June 14 - 20, 2014
CORPORATE
CIPLA TO PICK UP 60% IN SRI LANKAN FIRM
The Hindu Business Line, 18 June, 2014
Drug-maker Cipla has signed an agreement with its Sri Lankan distributor to pick up a 60 per cent stake in a
new company that will handle its distribution in Sri Lanka. Cipla will fork out $14 million for a 60 per cent
stake in the new entity. The deal was inked by Cipla (Mauritius) Ltd, a wholly owned subsidiary, and
Citihealth Imports (Pvt) Ltd, Cipla's existing Sri Lankan distributor. The Indian company did not explain
the rationale behind the move or its timing. Cipla, which has operated in Sri Lanka for more than 15 years,
is a big player in the market. This acquisition will further strengthen its presence in the country, the
company said. In the recent past, Cipla has moved to ramp up its presence in other markets. Late last year, it
picked up 100 per cent in Celeris, its distributor in Croatia, for an undisclosed sum. Cipla's Managing
Director and global Chief Executive Sub-hanu Saxena had then said that the move was in line with the
company's ambition to "front-end and establish a platform to market our own products".
US FDA CITES APOTEX'S INDIAN DRUG FACILITY FOR FRAUDULENT DATA
Economic Times, 18 June, 2014
An Indian subsidiary of Canadian drug company Apotex Inc manipulated laboratory data, retesting samples
until the results were acceptable, according to a warning letter posted by the U.S. Food and Drug
Administration on its website on Tuesday. The letter, dated June 16, referenced an FDA inspection that took
place in January at the company's facility in Bangalore, India, where inspectors found significant deviations
from good manufacturing practices. The inspection found that the company, which makes pharmaceutical
ingredients, routinely completed sample analyses and recorded the data only if the results were acceptable.
"If the results obtained were atypical, a fresh sample was to be prepared and analyzed," the FDA said in its
letter. "The original sample testing was not recorded." In April, the FDA banned imports from the facility,
saying it did not comply with quality standards. The move followed similar bans on certain products from
Indian drugmakers Ranbaxy Laboratories Ltd, Wockhardt Ltd and Sun Pharmaceutical Industries Ltd. The
FDA said a response by privately held Apotex in February to the agency's inspection report "lacks sufficient
corrective actions" and that the issues raised during the inspection "demonstrate a general lack of reliability
and accuracy of data generated by your firm's laboratory." The agency said the company's failure to create
and maintain accurate documentation "is a repeat observation reported to your facility during the 2006 and
2010 inspections." The FDA said that until the company corrects all the deviations, it may withhold
approval of any new product applications. Apotex officials were not immediately available.
US LAUNCHES, INDIA BIZ KEY FOR TORRENT PHARMA
Business Standard, 18 June, 2014
In recent months, the Torrent Pharma stock has been an outperformer due to upgrades following its
performance in the quarter ended March and moves to expand its domestic business, including the
acquisition of Elder Pharma's branded formulation business in December 2013. Emkay Global has upgraded
the company's FY15 earnings estimates 38 per cent to Rs43.3. Analysts at Anand Rathi believe the strong
growth momentum will be led by 8-10 generic launches in the US in FY15, faster growth in domestic
business after the Elder consolidation and traction in the EU and other global markets. Given the growth
prospects, the research firm believes the stock is attractively priced at 17 times its FY15 earnings estimates.
One of the reasons for the strong March quarter show (41 per cent year-on-year revenue growth) was
exclusivity gains from anti-depressant drug Cymbalta, which added Rs210 crore to the revenue of Rs1,225
crore. Gains from the product launch and a low base helped the US business grow 335 per cent year-onyear. Domestic formulations added to the overall show, growing 17.4 per cent in the March quarter. The
company has been able to outperform the sector in FY14, though the year was a weak one for the sector due
to pricing and trader commission issues. Given the product pipeline, the company is expected to grow at a
faster pace than peers in FY15.
DR REDDY'S RECALLS OVER 13,000 BOTTLES OF HYPERTENSION DRUG: FDA
Economic Times, 19 June, 2014
Drug maker Dr. Reddy's Laboratories has initiated voluntary recall of Metoprolol Succinate Extended
Release Tablets, USP 25 mg. 100-count bottles from US market following failure of dissolution test,
USFDA said. According to a notification by the FDA, the recall of the 13,560 bottles has been voluntarily
initiated by the company through a letter to the regulator last month under 'Class-II' classification.
Metoprolol is used alone or in combination with other medications to treat high blood pressure. It also is
used to prevent angina (chest pain) and to improve survival after a heart attack. The regulator's website
cited "Failed Dissolution Specifications: failure of dissolution test observed at 18 month time point," as the
reason for recall. Tablet Dissolution is a standardised method for measuring the rate of drug release from a
dosage form. Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, (100-count bottle) were
manufactured by Dr Reddy's at one of its Hyderabad manufacturing facilities and distributed by Dr. Reddy's
Laboratories Inc. in the US. According to the US health regulator, Class II recall is a situation in which use
of or exposure to a violative product may cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health consequences is remote. Shares of Dr.
Reddy's were trading at Rs 2435.20, up 0.51 per cent on the BSE in the morning trade.
OMRON HEALTHCARE INDIA EYES SALES OF RS 110 CRORE IN FY'15
Economic Times, 18 June, 2014
Omron Healthcare India today said it is looking at a revenue of Rs 110 crore for the current financial year as
it plans to expand it's reach by entering new distribution channels. "The company aims to clock in a
turnover of Rs 110 crore in this FY which indicates a growth of around 54 per cent over the previous FY,"
Omron Healthcare India Managing Director Shinya Tomoda said in a statement. For this, the company is
striving to expand its reach by entering new distribution channels - online shopping portals and electronics
retail chains, he added. The company is also planning to intensify its pan-India marketing efforts through a
TV commercial campaign which shall be rolled out in August this year, Omron said. The company is further
spreading the network of its traditional channels across India, it added. Omron Healthcare India markets
various products including blood pressure monitoring systems, home glucometer, body fat monitors,
pedometers, digital thermometers, respiratory therapy devices, massage devices. The company is a part of
Omron Corporation that globally employs over 30,000 people in more than 35 countries.
CIPLA PARTNERS WITH HETERO TO LAUNCH BIOSIMILAR ANAEMIA DRUG
Economic Times, 19 June, 2014
Pharma major Cipla today announced a collaboration with Hetero Drugs to launch a medication under the
Actorise brand for treatment of anaemia caused due to chronic kidney disease. "The collaboration stands as
a multi-partner co- marketing deal which offers Cipla a license to make the drug accessible to a wide
number of patients in India," the company said in a statement. Actorise is a biosimilar of 'Darbepoetin alfa',
which is marketed by US-based Amgen under the brand Aranesp. Cipla said Actorise is available in the prefilled syringes (PFS) in the strengths of 25 mcg and 40 mcg priced at Rs 1,500 and Rs 2,200 respectively.
Commenting on the development, Cipla Chief Medical Officer Jaideep Gogtay said: "The launch of
Darbepoetin alfa reinforces our strong commitment to expand the product pipeline in biosimilars and to
increase product access in various therapeutic areas." The company anticipates more number of deals across
therapy areas in the near future, he added. "More than 1,00,000 patients each year need renal replacement
therapy -- dialysis and renal transplant. Most of these patients develop anaemia and will need drugs such as
Darbepoetin alfa to maintain their hemoglobin and reduce the need for blood transfusions," Gogtay said.
Darbepoetin alfa, a second generation erythropoietin maintains the hemoglobin levels for a longer period of
time, and so the dose is only once a week, Cipla said. Mumbai based Cipla's portfolio includes 2,000
products in 65 therapeutic categories. Shares of Cipla were trading at Rs 424.30 per scrip in the afternoon
trade on BSE, down 0.20 per cent from it's previous close.
DECKS CLEARED FOR $218-MN ORCHID PHARMA-HOSPIRA DEAL
Business Standard, 18 June, 2014
The debt recovery tribunal (DRT) here on Tuesday cleared the decks for Orchid Chemicals and
Pharmaceuticals Ltd (Orchid Pharma) to transfer its penicillin and penem active pharmaceutical ingredient
(API) business, along with a few facilities, to US-based Hospira, according to a $200-million deal
announced in August, 2012. On Tuesday, the DRT vacated a stay on a business transfer agreement between
the two companies, issued about a year ago in favour of ING Vysya Bank, a lender to Orchid Pharma.
During the hearing, ING Vysya Bank argued Orchid Pharma had to pay Rs44 crore, which the bank had
given as working capital. Before implementing any agreement, ING the bank's accounts should be settled, it
said. It added it had opposed corporate debt restructuring (CDR) for the company, as it would get only a few
crores if CDR was carried out. However, Orchid Pharma argued the CDR proposal was accepted by an
empowered group on CDR. According to the CDR proposal, the company's 22 lenders were to let go of
Rs364 crore, mostly interest. Recently, a dispute between the company and one of its largest shareholders,
billionaire investor Cyrus Poonawalla and his group (including biotech firm Serum Institute), was heard by
the Chennai bench of the Company Law Board (CLB).
NOVARTIS, PEPSI MAY SIGN DRUG DISTRIBUTION PACT
Economic Times, 19 June, 2014
Beverage giant Pepsi and Novartis might start a pilot project to collaborate on a possible distribution and
logistics tie-up, according to a senior executive of Novartis. Both companies are exploring ways where
Novartis can make use of the deep distribution network of Pepsi, along with their cold storage facilities.
"Today, a Pepsi and Coca-Cola is available in every village, but a paracetamol is not. But they have great
logistics and a cold supply chain. So, products like insulin, as you go interiors, are affected by temperature.
The products become puerile and essentially counterfeit. So, we are talking to do a pilot with Pepsi where
we can ally with this company and create a model which works," said the executive, requesting anonymity.
US FDA RAISES CONCERNS OVER WOCKHARDT'S US UNIT
Express Pharma, 14 June, 2014
THE US Food and Drug Administration (US FDA) has expressed concerns over production processes at the
US unit of Wockhardt, a top executive said, possibly adding to a spate of regulatory troubles facing the
Indian generic drugmaker. The US is Wockhardt's biggest market and the US FDA has already banned the
import of generic drugs from its two plants in India, citing quality lapses in the manufacturing process.
Murtaza Khorakiwala, Managing Director, Wockhardt said on Tuesday Wockhardt had responded to the
FDA's observations but declined to give details. If the FDA is not satisfied with the response, it could ban
production from its Chicago-based Morton Grove Pharmaceuticals unit, which accounts for more than 50
per cent of Wockhardt's sales in the US, a region that contributed 45 per cent to its sales in the fiscal year
ended March. The FDA had sent Wockhardt a 'Form 483,' a letter in which the agency typically outlines
concerns discovered during inspections. Worries about quality control in India's $15 billion drug industry
surfaced in the past year after plants run by Ranbaxy Laboratories and Wockhardt were barred from sending
drugs to the US after falling short of the FDA's 'good manufacturing practices'. That has hurt India's
reputation as a supplier of safe, affordable drugs. Indian drug exports grew by just 2.6 per cent in the
2013/14 fiscal year ended in March. Two years ago, the growth rate was 23 per cent.
CIPLA'S DRUG PIPELINE TURNS IT INTO $10-BN TARGET
Business Standard, 19 June, 2014
Indian drugmaker Cipla may be the industry's next target in a record run of takeovers. Cipla, a maker of
generic HIV, cancer and respiratory medications, has almost doubled the number of treatments under
development in the past year and analysts projects its revenue will surge 60 per cent by 2017. Drawn by
demand for the $5.7 billion company's medicines internationally and factories across India, Teva
Pharmaceutical Industries or Mylan maybe suitors, said IIFL Holdings. After Mumbai-based Cipla bought
its South African distributor and raised its stake in a Ugandan manufacturer to gain more control of exports,
buyers may have to offer at least $9.7 billion to convince the founders to sell, said Angel Broking Ltd. Any
deal would follow about $190 billion of global drug and medical-products takeovers this quarter, according
to data compiled by Bloomberg. Cipla is "in investment mode," Prakash Agarwal, an analyst at CIMB
Securities India in Mumbai, said by phone. "They are preparing the bride. And everybody's out shopping."
Shares of Cipla today rose as much as 3 per cent in Mumbai before trading up 3.2 per cent at 426.30 rupees
at 12:59 pm. A spokeswoman for Cipla declined to comment on any potential takeover. Founded in 1935 by
scientist Khwaja Abdul Hamied, Cipla is India's fourth-largest pharmaceutical company by market value.
The Hamied family still owns about 37 per cent of the shares, according to Cipla's most recent results.
WOCKHARDT, BSES MG HOSPITAL ORGANISE BLOOD DONATION CAMP; TO PROVIDE
FREE BLOOD TO POOR
Pharmabiz, 16 June, 2014
In their commitment towards initiating blood donation drive, and to commensurate world blood donor day,
Wochardt Foundation in association with BSES MG Hospital of the Brahma Kumaris’ recently organised a
blood donation camp at Wockhardt Towers. Through this joint initiative, 30 per cent of the donated blood
will be made available free of cost to people below poverty line. Through this joint initiative, Wockhardt
Foundation and BSES MG Hospital will be making the blood available to children suffering from
thalassemia, cancer patients, surgeries, accident cases and other medical emergencies. Dr Huzaifa
Khorakiwala, trustee and CEO, Wockhardt Foundation said, “Underprivileged people cannot afford blood
for transfusion in emergency cases. I came across several cases where such people suffered and died
because of lack of financial assistance. This world blood donor day, Wockhardt Foundation engaged all
employees of the Wockhardt group to donate their blood towards this noble cause. We thank the BSES MG
Hospital for helping us achieve this kind act.”
PORTEA TO SET UP IN-HOME HEALTH CARE NETWORK IN 50 CITIES
Economic Times, 15 June, 2014
By investing $30-40 million, in-home healthcare services provider Portea Medical plans to expand to 50
Indian cities over the next two years. "We are by far the largest and fastest growing home healthcare
provider in the Indian market today. Our target is to be in 50 Indian cities which have a population of above
1 million) in the next 24 months," said Meena Ganesh, CEO and co-founder of Portea Medical,. Six months
ago, they had raised $8 million (around Rs 48 crore) in series A funding from Accel Partners and
Ventureast. "We are aiming to raise our series B funding of $30-40 million in the next 12 months and are
looking at all options, including the PE route for these funds," she said. Started last year, the Bangalorebased company has already expanded to 18 cities using their proprietary technology platform. Their
Kolkata chapter started recently while they are already present in other cities like Hyderabad, Pune,
Coimbatore, Lucknow and Vizag. The company CEO said Bangalore and the Delhi/NCR region followed
by the other metros accounts for the bulk of their patient base. Currently, Portea handles approximately
18,000 patient visits every month with its 1000 employees which include doctors, physiotherapists and
nurses. Portea estimates that the home health care market is between 2-4 billion $ and in the next 10 years
the size of the industry would grow to over 15 bn USD in India. A relatively new concept in India, home
health care is being targetted at the elderly, patients who are immobile, terminally ill and patients requiring
simple but repetitive treatments like physiotherapy, dressings and daily injections
GRANULES INDIA'S FACILITY PASSES USFDA INSPECTION
Financial Chronicle, 17 June, 2014
DRUG firm Granules India's paracetamol manufacturing facility at Bon-thapally in Andhra Pradesh has
passed an inspection by the US health regulator. The company's paracetamol facility has successfully passed
a United States food and drug administration (USFDA) inspection without any 483 observations, Granules
India said in a filing to the BSE. The facility has the world's largest single active pharmaceutical ingredient
(API) production line by volume, it added. An FDA Form 483 is issued to the firm's management at the
conclusion of an inspection when an investigator^) has observed any conditions that in their judgement may
constitute violations of the food drug and cosmetic (FD&C) Act and other related acts. The company's four
API facilities have passed the USFDA inspections in the past 12 months, Granules India said. Hyderabadbased Granules India has facilities for APIs, pharmaceutical formulation intermediates (PFIs) and finished
dosages, serving customers in over 60 countries. Shares of Granules India were trading at Rs 401.75 per
scrip in the afternoon trade on Monday, up 1.40 per cent from its previous close, on the BSE. Granules India
Limited is a fast growing pharmaceutical company with world-class facilities for APIs, PFIs and Finished
tomers in over 60 countries. We are committed to excellence in manufacturing, quality and customer
service. We are headquartered in Hyderabad with offices in 'the US, U.K., Colombia and China with
manufacturing facilities in India and China. The company have focused on a core portfolio.
AUROBINDO EYES MAJOR GROWTH IN US
Business Standard, 17 June, 2014
Hyderabad-based Aurobindo Pharma is expecting a significant growth in the business of its US-based
wholly owned subsidiaries Aurolife and AuroMedics Pharma LIC. While Aurolife is a generic
pharmaceutical product manufacturer, AuroMedics is responsible for generic injectable pharmaceutical
products in the US. According to Aurobindo's managing director N Govindarajan, AuroMedics continued to
see a steady increase in quarterly sequential sales over the past couple of years and generated $12 million
(around Rs 72 crore) in Q4 of FY14. The annual sales from the company at $ 37 million (Rs 222 crore) last
year, almost tripled the number in previous fiscal. Similarly, Aurolife saw an improvement in sales and
turned profitable in 2013-14 generating a revenue of $74 million (Rs 444 crore). In the current financial
year, AuroMedics expects to generate a revenue of $60 million (Rs 360 crore). "Our run rate is averaging
about ($) 5 million a month for this fiscal year, so that is 60 million total year for injectables," AuroMedics
president, Ronald Quadrel, told a conference call held by Aurobindo. Replying to questions, Quadrel said
the company was going to see a lot more growth going forward from the injectable side. "Right now we
have 45 files with FDA (US Food and Drugs Administration) under review. We are expecting another 8 to
9 this calendar year and another 30 next year. So I am expecting in calendar year 2015 between 20 and 30
approvals and in calendar year 2016 about the same. Depending on the timing of those particular approvals,
we could see significant growth over the next two to three years on the Injectable side." Quadrel also stated
AuroMedk would commission 'Oncology Block' most probably in March 2015 and filing of products with
USFDA would start towards the year-end.
LUPIN SEEKS EUROPE GENETICS ACQUISITIONS OF UP TO $1 BN
Business Standard, 17 June, 2014
Lupin, the drugmaker founded by Indian billionaire Desh Bandhu Gupta, is seeking to build its business in
Europe by acquiring generics manufacturers for as much as $1 billion. Lupin is looking for companies with
capabilities in complex generics like inhalation products and injectables, dermatology products, and
biosimilar drugs, Chief Executive Officer Vinita Gupta said in a phone interview. Europe is attractive
because it has clearer regulations than the US on biosim-ilars, or copies of biotechnology therapies. Europe
contributed 3 percent of Lupin's sales last year, while competitor Ranbaxy Laboratories, which agreed to be
acquired by Sun Pharmaceutical Industries Ltd., earned about 24 per cent of revenue from the region. "In
the US, we have a very strong footprint," Gupta, the founder's daughter, said in a telephone interview from
the company's US office in Baltimore. "In Europe, we are really small. So we have a focus in looking at
building a specialty presence as well as a generics presence." Lupin shares rose 0.3 per cent to Rs.986.60 as
of 9:41 a.m. in Mumbai. The Benchmark S&P BSE Sensex fell 0.4 per cent. Russia, China In addition to
specialised drugmakers with markets in Western Europe, Mumbai-based Lupin is looking for companies
that give it access to generic markets in Russia, China and Brazil. It also wants "larger, transformational
assets" that give access to multiple geographies as well as additional manufacturing capability, Gupta said.
The company is willing to spend $50 million to Si billion, she said. Lupin this year announced acquisitions
of Nanomi BV, a Netherlands-based company with technology to develop complex injectables, and
Laboratories Grin SA de CV, a Mexican manufacturer of ophthalmic products. Since 2007, Lupin has
acquired nine other brands and companies, including Tokyo-based generic injectables manufacturer From
Pharmaceutical, according to data compiled by Bloomberg. Lupin had cash and near-cash items of about
Rs.800 crore at the end of March.
ARVIND REMEDIES SIGNS MOU WITH ADESH UNIVERSITY TO LAUNCH NEW DRUGS
Economic Times, 16 June, 2014
Drug firm Arvind Remedies has inked a pact with Adesh University to make formulation products targeting
certain diseases such as diabetes and depression based on the Punjab based institution's patents. "The
company has signed Memorandum of Understanding with Adesh University, Punjab, to transfer the patent
rights to the company for manufacturing and marketing of formulation products from botanical source for
treatment of Type 2 diabetes, coronary heart disease, neuro and anti-depression," Arvind Remedies said in a
filing to the BSE. The drugs will be manufactured in form of tablets and will be launched in the domestic
market by 2017 followed by the global market, it added. Shares of Arvind Remedies today closed at Rs
37.10 per scrip on BSE, up 0.41 per cent from its previous close.
DR REDDY'S UNVEILS MELGAIN LOTION
The Hindu Business Line, 14 June, 2014
Drug maker Dr Reddy's Laboratories launched Melgain, a lotion that has been approved for the treatment of
vitiligo (skin pigmentation disorder).The medication has been launched in partnership with Issar
Pharmaceuticals. Vitiligo is a skin disease that leads to white patches due to the loss of normal skin pigment
called melanin. Globally, Melgain lotion is the first peptide-based drug for the treatment of vitiligo. It has
been indigenously developed in India. OUR BUREAU
LUPIN LAUNCHES CIPROF LOXACIN IN US
Mint, 14 June, 2014
Drug firm Lupin Ltd has launched its generic Ciprofloxacin, used for treating bacterial infections, in the
American market, and is expecting 180 days of market exclusivity, pti
SRL DIAGNOSTICS STRESSES ON TIMELY DIAGNOSIS, WARNS AGAINST MONSOON
RELATED ILLNESS
Pharmabiz, 17 June, 2014
SRL Diagnostics said that timely diagnosis during fever season is a must to avoid major complication from
monsoon related issues. In this move, SRL Diagnostics alerted that malaria and dengue are not the only
illnesses to be wary of during this monsoon and promised reports in three hours’ time to avoiding losing
count of platelets drastically. SRL Diagnostics has a comprehensive testing mechanism which has BACTEC
advantage that evaluates cultures for illnesses with decreased time-to-detection, and leads to potential
decrease in length of hospital stay. SRL Diagnostics has FDA-approved, advanced culture and drug
susceptibility testing systems which provide rapid diagnosis and has enhanced sensitivity and specificity
with less chances of contamination. Variety of panel formats (conventional and synergy) support any
workflow with a range of antibiotics being updated every year including the latest drugs as per CLSI
guidelines. The methodology helps ensure detection of emerging and low-level resistance as well.
According to the statistics from SRL Diagnostics, the number of typhoid cases has shot up from 8000 in
January this year, to 17,520 ( by a whopping 119 per cent) in May, similarly, the number of people infected
with malaria also has been rising steadily. Compared to the 9930 cases in January, 15,306 (up by 54 per
cent) cases have been reported in May. The number of leptospirosis cases has shot up from 260 in January
this year, to 326 (a rise of 25 per cent) in May. Overall, number of people screening for fever has risen from
934 in January to 1256 (35 per cent rise) in May. While the rise in the number of such diseases is common
during monsoon, doctors fear that there may be a sudden spurt in numbers. Some of the most common ones
include viral fever, the common cold, malaria, and dengue.
POLYCOM TO BOOST PRODUCTIVITY WITH PERSONAL VIRTUAL MEETING ROOMS
FOR HEALTHCARE INDUSTRY
Pharmabiz, 16 June, 2014
Polycom RealPresence One is all set to change the dynamics of the video conferencing market in India
particularly in the healthcare space. Launched early this year and has been useful for industries like
manufacturing, healthcare, education, government, financial services and various other verticals, it is now
available across all the cities in India. It is a comprehensive package for video and content collaboration
which is now sold by subscription making it even easier for companies to adopt human collaboration.
According to a recent forecast by Gartner, the top 10 technology trends and drivers that will be strategic for
Indian organizations in 2014 include ‘collaboration technologies’ which encompasses voice over IP, file
sharing, videoconferencing, content archiving, media streaming, feedback and polling. Real-time
collaboration technologies not included in the web conferencing category include instant messaging and
stand-alone audio conferencing. In India where enterprises look for a customized product or service for all
their business needs, now with Polycom RealPresence One organisations can choose from the new, flexible
video delivery options available, including hybrid and on-premises video, depending on the option that
works best for their business models and budgets. All of the options include the same benefits now what the
size of the investment making RealPresence One truly scalable.
INTERNATIONAL
VIIV HEALTHCARE ENTERS AGREEMENT WITH JANSSEN TO DEVELOP SINGLETABLET COMBINING DOLUTEGRAVIR & RILPIVIRINE FOR HIV-1 TREATMENT
Pharmabiz, 14 June, 2014
ViiV Healthcare, a global specialist HIV company established by GSK and Pfizer, has entered into an
agreement with Janssen R&D Ireland Ltd (Janssen) for the development and commercialisation of a singletablet combining dolutegravir (Tivicay) and Janssen’s non-nucleoside reverse transcriptase inhibitor
rilpivirine (Edurant). This represents ViiV Healthcare’s first external collaboration to develop a single-tablet
regimen with another company’s branded product and builds on ViiV Healthcare’s strategy to expand its
portfolio of dolutegravir-based regimens, which started with the approval of dolutegravir for use in
combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency
virus (HIV-1) infection in adults and children aged 12 years and older weighing at least 40 kg (approx. 88
lbs) in the US, and HIV infected adults and adolescents above 12 years of age in Europe. As part of this
agreement, the two companies will investigate the potential of combining dolutegravir and rilpivirine into a
single-tablet in order to expand the treatment options available to people living with HIV. Studies included
in the new development programme are expected to begin by Q1 2015 and will investigate the two drug
combination regimen as an HIV maintenance therapy for patients already virally suppressed on a three drug
regimen. The companies will further investigate the development of paediatric fixed-dose formulations
which combine dolutegravir and rilpivirine.
NOVARTIS SEEKS US FDA MARKETING NOD FOR MENINGITIS B VACCINE CANDIDATE,
BEXSERO TO HELP PROTECT ADOLESCENTS & YOUNG ADULTS
Pharmabiz, 18 June, 2014
Novartis has submitted a Biologic Licence Application (BLA) to the US Food and Drug Administration
(FDA) for marketing approval for the use of Bexsero (Multicomponent Meningococcal Group B Vaccine
[recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B
(meningitis B) in adolescents and young adults from 10 years through 25 years of age. This submission
initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough
Therapy designation in April. "Bexsero is the result of 20 years of groundbreaking research and a testament
to our leadership in preventing rare but devastating diseases," said Andrin Oswald, Division Head, Novartis
Vaccines. "With today's submission, we are one step closer to ensuring that no family in the US has to
endure the loss of a loved one from vaccine-preventable meningitis." Bexsero is the first broad coverage
vaccine to help protect against meningitis B. The vaccine is already approved in 34 countries including
across the European Union, Canada and Australia. Since the launch of Bexsero in 2013, over half a million
doses have been distributed worldwide. In the US, Novartis has provided nearly 30,000 doses of Bexsero to
students and staff at Princeton University and the University of California Santa Barbara (UCSB) following
meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from the
FDA. Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the
incoming freshman class at Princeton University in the at-risk group to receive Bexsero.
AMGEN JOINS NCI AND RESEARCH PARTNERS TO HELP ACCELERATE DEVELOPMENT
OF PERSONALISED TREATMENT APPROACHES FOR SQUAMOUS CELL LUNG CANCER
Pharmabiz, 18 June, 2014
Amgen announced that it will collaborate with the National Cancer Institute (NCI), part of the National
Institutes of Health, and other public and private sector partners on the Lung Master Protocol (Lung-MAP),
a groundbreaking new clinical trial programme that will use biomarker-driven research and genomic
profiling to match squamous cell lung cancer patients to investigational treatments based on their individual
cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets
under one trial protocol. Approximately 500 to 1,000 patients will be screened each year for more than 200
cancer-related genes, and the screenings will inform trial arm selection. Five investigational drugs have
been selected for inclusion in the initial trial, including Amgen's rilotumumab, an investigational fully
human monoclonal antibody designed to inhibit cancer cell growth and migration. "Amgen has been at the
forefront of biomarker research in an effort to help the medical community understand the different
mechanisms of cancer progression and ensure that patients receive treatments that will provide the greatest
benefit," said Sean E. Harper, M.D., executive vice president of research and development at Amgen. "This
latest collaboration can significantly speed our understanding of targeted approaches for this complex and
underserved form of lung cancer, while demonstrating how genomic testing can drive the evolution of
clinical trial design. It may ultimately tell us more about how best to match patients to the right treatments."
MEDTRONIC TO BUY COVIDIEN FOR 12.9 BN, REBASE IN IRELAND
Financial Express, 17 June, 2014
US medical device maker Medtronic said it has agreed to buy Dublin-based Covidien for $42.9 billion and
shift its executive headquarters to Ireland in the latest move by US firms to harvest lower corporate tax rates
abroad. While the cash and stock deal will allow Medtronic to reduce its overall global tax burden, the
Minneapolis-based company said on Sunday it was driven by a complementary strategy with Covidien
onmedical technology, rather than tax considerations. "The real purpose of this, in the end, is strategic, both
in the intermediate term and the long term," Medtronic chief executive Omar Ishrak said in an interview
after the deal was announced. "It is good for the US in that we will make more investment in US
technologies, which previously we could not." Medtronic's corporate tax rate, now at around 18%, won't
change much, Ishrak said. Themergerof Medtronic, the world's largest stand-alone medical device maker
with a market value of over $60 billion, and Covidien, a maker of devices used in a range of surgical
procedures, will create a close competitor in size to the medical device business of industry leader Johnson
& Johnson. ItbroadensMedtronic'sscope beyondits array of heartdevices, spinal implants, insulin pumps and
other products into areas such as weight-loss surgery and laparoscopic procedures. The expansion should
allow it to better competeforbusinessfromhospitals, particularly in the United States where healthcare
reform efforts and shrinking government reimbursement for medical procedures has kept pressure on device
pricing. The disparate businesses means there should not be significant antitrust concerns, industry analysts
said.
GLAXO IN $350M CANCER DEAL WITH BIOTECH SPECIALIST
Western Times, 16 June, 2014
GlaxoSmithKline has agreed a $350 million deal with Adaptimmune to help develop and sell the
biotechnology firms cancer drugs, the companies said. Adaptimmune announced in a statement thatlt has
entered into a strategic cancer immunotherapy collaboration with GSK to develop and commercialize novel
cell based therapies in its lead clinical cancer program. The biotech firm, which is based in Oxford,
southern England and Philadelphia, has had success in trials in using T cells, the heavy weaponry of the
immune system, to target cancer cells. The GSK deal, worth the equivalent of 260 million euro could yield
payments to excess of $350 million to Adptimmune over the.next seven.years; according to the statement
MYLAN RECALLS DRUG MADE IN INDIA
Mint, 19 June, 2014
London: US drug maker Mylan Inc. is recalling batches of the injectable antibiotic clarithromycin made in
India due to possible impurities, Britain's healthcare regulator said on Wednesday. The Medicines and
Healthcare Products Regulatory Agency, or MHRA, said the decision was due to the potential for small
particles of white material to be present in individual vials.
ASTRAZENECA SIGNS LICENSING PACT WITH SYNAIRGEN FOR SNG001 AS NOVEL
IMMUNO-MODULATORY THERAPY FOR VIRAL-INDUCED EXACERBATION IN ASTHMA
Pharmabiz, 14 June, 2014
AstraZeneca has signed a global licence agreement with Synairgen Plc, an AIM-listed UK company
specialising in respiratory diseases, for SNG001, a novel, inhaled interferon beta (IFN-beta) in clinical
development for treating respiratory tract viral infections in patients with severe asthma. SNG001 supports
the immune system by correcting a deficiency which makes patients vulnerable to respiratory tract viral
infections. Under the terms of the exclusive licence agreement, AstraZeneca will pay Synairgen a $7.25
million up-front fee and potential development, regulatory and commercial milestones of up to $225
million. In addition, AstraZeneca will pay tiered royalties ranging from single-digit up to mid-teens on
commercial sales. AstraZeneca will be responsible for future development costs. In early 2015, AstraZeneca
will commence a phase IIa study in patients with severe asthma, building on available clinical data from an
initial phase lla trial in a broad asthma population. SNG001 also provides the opportunity to expand the
clinical programme in other pulmonary diseases including chronic obstructive pulmonary disease (COPD).
Maarten Kraan, head of respiratory, inflammation & utoimmune innovative medicines, AstraZeneca, said:
BRECKENRIDGE PHARMA LAUNCHES GENERIC CYMBALTA CAPSULES
Pharmabiz, 14 June, 2014
Breckenridge Pharmaceutical, Inc., a privately-held pharmaceutical marketing, research and development
company, launches duloxetine delayed-release capsules. The US Food and Drug Administration granted
final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and
supplied by its parent company, Laboratorios Dr. Esteve, S.A. Barcelona, Spain, and will be available in
20mg, 30mg and 60mg strengths. Duloxetine delayed-release capsules are AB rated to Cymbalta, a drug
marketed by Eli Lilly, for the treatment of major depressive disorder (MDD). This milestone signifies the
first vertically-integrated product developed and commercialised between Breckenridge and Esteve.
EMA'S PRA COMMITTEE BEGINS REVIEW OF IBUPROFEN MEDICINES
Pharmabiz, 17 June, 2014
The European Medicines Agency's (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC)
has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those
taken by mouth but not topical medicines like creams and gels). The cardiovascular risks being evaluated
concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken
at lower doses and for short periods of time. There is therefore no suggestion of a similar cardiovascular
risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely
used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.
Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The
safety of these medicines including their cardiovascular risks has been under close review by the EMA and
national regulatory authorities for many years. Data, in particular the results of a published analysis of
clinical trial data, have suggested that the cardiovascular risk with diclofenac and high-dose ibuprofen
(2,400 mg) may be similar to the known risk with COX-2 inhibitors (also of the NSAID class). In 2013, the
PRAC considered the available data relating to diclofenac and issued recommendations to minimise their
risks. The PRAC is now considering the available data relating to high-dose ibuprofen.
IHEALTH INTRODUCES PORTABLE MOBILE BLOOD GLUCOSE MONITOR, IHEALTH
ALIGN
Pharmabiz, 16 June, 2014
iHealth Lab Inc., a leader in the design and development of mobile personal healthcare solutions,
announced the launch of the iHealth Align, the world's smallest, FDA-approved mobile blood glucose
monitor. The meter plugs directly into a smart phone and displays and stores readings using the iHealth
Gluco-Smart app. By displaying readings directly on the phone screen, iHealth was able to shrink the
device size to just slightly larger than the circumference of a quarter. The compact size and mobile sync
capability make iHealth Align a small and powerful new tool for diabetes management. iHealth also
announced the iHealth Simple Savings program to eliminate complexities associated with insurance
paperwork by significantly lowering the price of their proprietary test strips. The new price is about onequarter of the list price of most name brand test strips, placing it at or below the typical insurance co-pay
contribution. Users can now purchase iHealth strips and avoid hassles associated with reimbursement for
insurance coverage. The Simple Savings program will also incorporate an option in the near future to
automate test strip replenishment through the iHealth Gluco-Smart mobile app, which intelligently tracks
individual test strip usage, allowing for accurate and timely refills.
ULRICH MEDICAL INTRODUCES NEW SPINAL IMPLANT, UCENTUM COMPREHENSIVE
POSTERIOR SYSTEM IN US MARKET
Pharmabiz, 16 June, 2014
ulrich medical USA, an innovative medical technology company, announced the US market release of the
uCentum Comprehensive Posterior System for open and minimally invasive (MIS) surgical approaches
which is intended to provide immobilisation and stabilisation of spinal segments as an adjunct to fusion of
the thoracic, lumbar and sacral spine (T1-S2). "We are very excited to introduce the uCentum product to the
US spine market," said Christoph Ulrich, Managing Partner, ulrich medical, Inc. "The uCentum product
embodies design inputs from premier spine surgeons from across the globe and years of research and
development work, and we are confident that it represents the cutting-edge in technological advancements
in rod-screw implants." The uCentum pedicle screw consists of a simple low profile tulip-head, top loading,
cannulated, fenestrated and optimised (cortical to cancellous) thread design to address the increased
purchase requirements of poor bone quality. In addition, this system also features a unique prefixation screw
technology (dual locking) that adapts the screw head from a polyaxial to a monoaxial design, while still
allowing the rod to translate in order to offer true parallel compression or distraction of the vertebrae during
spinal surgeries. The screws are available in a variety of lengths and a wide range of sizes (from 4.5mm to
10.0mm) in order to match diverse patient anatomies for use during primary or complex revision surgeries.
Also, the system includes straight or curved titanium rods, and numerous reduction instruments and MIS
rod-delivery options to simplify the procedure for surgeons. Equally important, unlike most pedicle screw
systems available today, uCentum offers surgeons a unique 2-in-1 instrumentation set that encompasses
both open and MIS approach instruments and implants which allows surgeons to move between MIS and
open procedures while utilising one surgical set.
KALGENE, SRI, OCBN AND CIMTEC ANNOUNCE MULTI-YEAR COLLABORATION TO
TACKLE AGGRESSIVE CANCERS
Pharmabiz, 16 June, 2014
KalGene Pharmaceuticals, Inc. (KalGene), a company focused on the development of targeted therapeutics
and companion diagnostics for cancer, has announced that the company is expediting development of a
prognostic marker and companion therapeutic that specifically targets aggressive cancers. “KalGene is
focused on growth, with a vision to be a world class oncology company bringing targeted medicines to
patients, says Dr. Nathan Yoganathan, president and chief scientific officer at KalGene. We are developing
precision medicine tools that provide more effective cancer therapeutics that will also significantly alleviate
patient suffering during treatment and improve overall quality of life.” Precision medicine seeks to predict
which patients will respond to a particular therapy in advance of treatment. This allows physicians to only
prescribe treatment to the individuals who are most likely to benefit. KalGene has several projects in its
pipeline ranging from early stage research to clinical trials. The current project focuses on metastatic
disease, an unmet medical need for breast, colon and brain cancer. KalGene’s principals, Dr. John Gillard
and Dr. Nathan Yoganathan believe they have a unique solution and are enlisting the expertise of Canadian
and international partners. The complex project is a multi-stage and multi-year undertaking involving
Centre for Imaging Technology Commercialization (CIMTEC); Sunnybrook Research Institute (SRI); and
Ontario Cancer Biomarker Network (OCBN) at Queen’s University. CIMTEC is providing project
management services and coordinating the expertise of world-leading research laboratories in multiple
cities.
HILL-ROM TO ACQUIRE GERMAN-BASED TRUMPF MEDICAL FOR $250 MILLION
Pharmabiz, 17 June, 2014
Hill-Rom Holdings, Inc. (HRC), a leading global medical technology company, announced the signing of a
definitive agreement to purchase TRUMPF Medical, the medical unit of the privately held TRUMPF
Group, for approximately $250 million in cash. The transaction is expected to close late in the company's
fiscal fourth quarter and will be immediately accretive to adjusted earnings per share. TRUMPF Medical,
based in Germany, provides a portfolio of well-established operating room (OR) infrastructure products
such as surgical tables, surgical lighting, and supply units. Hill-Rom's surgical portfolio already includes
leading products for surgical safety and efficiency such as Bard-Parker scalpels, the Allen Advance Spine
Table, patient positioning accessories, surgical supplies and surgical fluids management systems. The
addition of TRUMPF Medical's line of integrated OR solutions doubles Hill-Rom's surgical portfolio with
market leading operating room products and positions the company to capitalize on new customer
partnerships. This acquisition also strengthens the company's geographic footprint in high-growth markets,
including Asia/Pacific, the Middle East, Eastern Europe, and Latin America.
ARATANA INKS LICENSING PACT WITH VET-STEM FOR ALLOGENEIC STEM CELL
THERAPY TECHNOLOGY
Pharmabiz, 16 June, 2014
Aratana Therapeutics, Inc. a pet therapeutics company focussed on licencing, developing and
commercialising innovative biopharmaceutical products for cats, dogs and other companion animals, has
entered into an exclusive licence agreement with Vet-Stem, Inc., for its novel, allogeneic stem cell therapy
technology. Under the agreement, Aratana obtains exclusive rights to commercialise Vet-Stem's allogeneic
stem cells in the United States, which if approved, will be the first FDA-regulated, "off the shelf"
regenerative cell therapy for the treatment of osteoarthritis in dogs. Vet-Stem pioneered the use of adipose
tissue as a source for stem cells in veterinary regenerative medicine, but to date has offered only autologous
stem cell therapy as a service (adipose tissue, also known as fat tissue, is harvested from the patient from
which stem cells are isolated then reintroduced into the same patient). The positive experience using
adipose-derived stem cells in this way is strong, with thousands of veterinarians utilising the service since
its introduction in 2004. Although excess doses can be frozen and banked, they can be used only as a future
therapy for the original donor patient. Vet-Stem has now developed a technology platform for producing
allogeneic stem cell therapies, where a single donor sample can be used to generate a large bank of doses
that can be stored and used to treat multiple patients. Aratana has licenced this allogeneic therapy, which
will be tested for safety and efficacy in randomised, placebo-controlled dogs with osteoarthritis and
submitted to the FDA for approval.
THERMO FISHER UNVEILS ADVANCED LAB FACILITY FOR BIO-PHARMA TO ACCESS
INNOVATIVE LIFE SCIENCES TECHNOLOGY
Pharmabiz, 16 June, 2014
Thermo Fisher Scientific Inc. has announced the launch of the Customer Experience Center (CEC) to
showcase its innovative technologies to new and existing customers. The advanced lab facility in Bengaluru
spans an area of 1800 sqft and is designed to meet the needs of life sciences covering genomics, proteomics
and cell biology. It is staffed by over 40 trained scientists. The CEC aims to showcase and deliver the latest
innovative solutions provided by Thermo Fisher Scientific to the life sciences research society of India.
Genomics plays an increasingly important role in driving discoveries in the life sciences. The study of
whole genomes enables researchers to find solutions to some of the most complex challenges in science.
“We have been supporting scientists’ needs by bringing key technologies to sustain our focus in India in the
areas of food security, fuel and health. The CEC will serve to showcase cohesive solutions for the scientific
community”, said Devashish Ohri, Managing Directorfor South Asia, Life Sciences Solutions, Thermo
Fisher. More than 24 training programmes have been scheduled for the year 2014 at CEC, which will
enhance the skills and knowledge of approximately 200 scientists, he added.
PFIZER OPENS NEW R&D SITE IN CAMBRIDGE, MASSACHUSETTS
Pharmabiz, 17 June, 2014
Pfizer Inc. has opened a new research and development (R&D) hub in Cambridge, Massachusetts. The new
Pfizer facilities in Kendall Square bring together 1,000 colleagues from three area locations and position
Pfizer in closer proximity to leading academic institutions, hospitals and patient organisations. “Our new
Kendall Square presence in Cambridge represents an important milestone in Pfizer’s approach to creating a
sustainable R&D engine that is designed to yield a flow of innovative therapies year after year,” said Mikael
Dolsten, M.D., Ph.D., president of worldwide research and development at Pfizer. “Having all of our
Cambridge-area researchers working closely together in one of the world’s most exciting biomedical
ecosystems will allow us to continue our efforts to grow our external collaborations and has the potential to
help speed the translation of scientific knowledge into potential medical breakthroughs across areas of
unmet need such as lupus, inflammatory bowel disease, kidney disease, type 2 diabetes, muscular dystrophy
and Parkinson's disease.” Led by Pfizer Group Vice President of BioTherapeutics R&D, José-Carlos
Gutiérrez-Ramos, Ph.D, the new laboratory facilities, located in the heart of Kendall Square at 610 and 700
Main Street, respectively, are leased from the Massachusetts Institute of Technology (MIT). Pfizer scientists
will work in state-of-the-art lab space on a range of clinical programmes across several therapeutic areas,
including inflammation, immunology, rare disease, cardiovascular and metabolic diseases, and
neuroscience.
GANEDEN EXPANDS GLOBAL FOOTPRINT EXPONENTIALLY WITH ITS PATENTED
PROBIOTIC INGREDIENT BC30
Pharmabiz, 17 June, 2014
Ganeden Biotech’s patented probiotic ingredient is now available in six of the seven continents. Ganeden
Biotech has announced that probiotic ingredient GanedenBC30 (Bacillus coagulans GBI-30, 6086) which
bagged several international regulatory approvals is now being shipped to six of the seven continents. This
means that its probiotic ingredient known for its digestive and immune benefits are now available globally
for food and beverage fortification. The company is engaged in probiotic research and product development
with an extensive library of published studies and more than 100 patents for probiotic technologies in the
food, beverage, animal health, and now personal care ingredients markets. It is known for its
GanedenBC30), a patented, FDA GRAS which is a highly stable probiotic ingredient. Its newest ingredient,
Bonicel, is the first science-backed, probiotic-derived, personal care ingredient shown to dramatically
reduce signs of aging. The global market of probiotic ingredients, supplements, and foods is expected to
reach nearly $27.1 billion in 2013 and register a compound annual growth rate of 6.2 per cent over the next
five years to reach $36.7 billion in 2018, according to Wellesley, MA- based technology markets research
firm BCC Research.
AGENA GETS US FDA PREMARKET CLEARANCE FOR IMPACT DX FACTOR V LEIDEN
AND FACTOR II GENOTYPING TEST
Pharmabiz, 17 June, 2014
Agena Bioscience, Inc., a life sciences and clinical diagnostics company, which recently acquired the
bioscience business of Sequenom, Inc., was notified by Sequenom, Inc. that it received premarket clearance
from the US Food and Drug Administration (FDA) for the Impact Dx Factor V Leiden and Factor II
Genotyping Test and the Impact Dx System. The Impact Dx Factor V Leiden and Factor II Genotyping Test
is performed on the Impact Dx System and is indicated for use as an aid in the diagnosis of patients with
suspected thrombophilia. The test is intended for in vitro diagnostic use in a clinical laboratory setting. The
Factor V Leiden mutation increases risk of venous thromboembolism seven-fold (when heterozygous) to
80-fold (when homozygous). Individuals heterozygous for the Factor II prothrombin mutation have 25%
higher plasma prothrombin levels than individuals with wild type genotype, and a 2.8-fold increased risk of
venous thromboembolism. “The clearance of our Impact Dx Factor V Leiden and Factor II Genotyping Test
on the Impact Dx System is a tremendous achievement that we believe contributes significant value to our
business and represents the transition of our proven research-use-only MassARRAY System into the clinical
diagnostics arena,” said John Lillig, Chairman and interim CEO of Agena Bioscience.
TWO INDEPENDENT REVIEW BOARDS, ASPIRE IRB & MIDLANDS IRB JOIN THE WIRBCOPERNICUS GROUP
Pharmabiz, 17 June, 2014
The WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services
for clinical research, announced that two independent review boards (IRBs) – Aspire IRB and Midlands
IRB – have joined the Group. Located near to San Diego, California and Kansas City, Missouri,
respectively, these companies expand WCG’s presence in two major clinical research hubs. The addition of
Midlands IRB and Aspire IRB also increases the Group’s expertise in early phase (I & II) reviews. WCG’s
chairman and CEO Donald A Deieso, commented, “We are delighted to welcome Midlands and Aspire to
our family; these two high quality organizations bring with them exceptional people, outstanding regulatory
and compliance records, and strong client relationships. Both Midlands and Aspire will continue to operate
independently and will retain their leadership, personnel, and brands. We look forward to providing both
organizations with expanded access to leading technology, capital, and corporate support which will assure
that they continue to deliver superior services to their clients.” As members of the WCG family, Midlands
IRB and Aspire IRB will have access to WCG’s significant resources, including state-of-the-art technology,
industry-leading advisory panels, and rigorous quality management and compliance programmes.
VERTEX SIGNS LETTER OF INTENT WITH PCPA TO ENABLE PUBLIC REIMBURSEMENT
OF KALYDECO IN CANADA FOR ELIGIBLE PEOPLE WITH CYSTIC FIBROSIS
Pharmabiz, 18 June, 2014
Vertex Pharmaceuticals, a global biotechnology company, has signed a letter of intent with the panCanadian Pricing Alliance (pCPA) to enable the public reimbursement of Kalydeco (ivacaftor) for the
treatment of eligible Canadians with cystic fibrosis (CF) ages 6 and older who have the G551D mutation.
The letter of intent represents an agreement in principle with the pCPA regarding the public reimbursement
of Kalydeco in Canada. However, before patients can get access through public reimbursement, each
participating province or territory must decide to reimburse Kalydeco through its individual drug
programme. In Canada, there are approximately 100 people ages 6 and older with this specific mutation.
Kalydeco is the first medicine to treat the underlying cause of cystic fibrosis for people with the G551D
mutation in the CFTR gene. Cystic fibrosis is a rare genetic disease for which there is no cure. CF is caused
by defective or missing CFTR proteins that result from mutations in the CFTR gene. The defective function
or absence of CFTR proteins in people with CF results in poor flow of salt and water into and out of the cell
in a number of organs, including the lungs. Kalydeco facilitates increased chloride transport by potentiating
the channel-open probability (or gating) of the CFTR protein. "The letter of intent signed with the panCanadian Pricing Alliance is an important step toward eligible Canadians receiving Kalydeco through
public reimbursement. However, our work is not complete until each province has added Kalydeco to its
individual drug programme to ensure people can get access to this medicine," said Stuart Arbuckle,
executive vice president and chief commercial officer for Vertex.
EMA VALIDATES MAA FOR ABBVIE'S ALL-ORAL, INTERFERON-FREE THERAPY FOR
GENOTYPE 1 CHRONIC HEPATITIS C TREATMENT
Pharmabiz, 18 June, 2014
AbbVie, a research-based global pharmaceutical company, announced that the Marketing Authorisation
Applications (MAAs) for its investigational, all-oral, interferon-free regimen for the treatment of adult
patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been validated and are under
accelerated assessment by the European Medicines Agency (EMA). Accelerated assessment, which is
designated to new medicines of major public health interest, was granted by the EMA for AbbVie's
investigational HCV regimen in May. Validation of the MAAs confirms that the submissions are complete
and starts the EMA's centralised review process. If approved, AbbVie's regimen could be available for
marketing in the European Union (EU) in the first quarter of 2015. The MAAs were submitted on May 8,
2014 and are supported by data from a large clinical program including six Phase III studies of more than
2,300 GT1 patients in over 25 countries. Review of the MAAs will be conducted under the centralised
licencing procedure, which, when finalised, provides marketing authorisations in all 28 member states of
the EU. On June 13, AbbVie announced that the New Drug Application (NDA) for AbbVie's regimen was
accepted and granted priority review by the US Food and Drug Administration (US FDA). The AbbVie
investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with
ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin (RBV). The combination of
three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of
optimising sustained virologic response rates across different patient populations.
INOVIO BROADENS ITS IP PORTFOLIO FROM THE UNIVERSITY OF PENNSYLVANIA
Pharmabiz, 18 June, 2014
Inovio Pharmaceuticals, Inc., a company engaged in revolutionizing vaccines to prevent and treat today's
cancers and challenging infectious diseases, has expanded its existing license agreement with the University
of Pennsylvania, adding exclusive worldwide rights to technology and intellectual property for novel
synthetic therapies against cancer, infectious diseases and new immune activators. Inovio has an ongoing
collaborative research agreement with the university to support fundamental research in the area of DNAbased vaccines and immunotherapies. All newly licensed products are in preclinical development. These
new pipeline candidates were developed using Inovio's SynCon design approach and were constructed and
tested in preclinical animal models for their ability to generate potent antigen-specific T cell and antibody
responses. Multiple patents have been filed and several manuscripts are being prepared for peer-reviewed
journal publications. Overall, this amendment broadens and strengthens the patent protection around
previously licensed oncology and infectious disease targets by in-licensing expanded patents covering
candidate products for DNA based synthetic antibodies and those covering dengue fever, H7N9 influenza,
additional HPV serotypes as well as certain other undisclosed cancer antigen targets. In addition, the
amended agreement provides Inovio global rights to: DNA-based synthetic antibodies – DNA plasmids are
able to generate not only antigens and immune activators, but also encode for various monoclonal
antibodies. Monoclonal antibodies (mAb) are designed to bind to a very specific epitope (area) of an
antigen or cell surface target and can bind to almost any selected target. mAbs have the unique ability to
alert the immune system to attack and kill specific cancer cells (as in the case of Yervoy) or block certain
biochemical pathways (such as those leading to rheumatoid arthritis, as in the case of Remicade).
Monoclonal antibodies, with their designer capabilities and potency, have consequently become a powerful
class of products against cancers, autoimmune diseases such as rheumatoid arthritis, and neurological
diseases such as multiple sclerosis. Immune Activators (IL-21, IL-23 & IL-33) -- Immune activators can
play a vital role in augmenting antigen-specific immune responses such as those generated by Inovio's DNA
vaccines. Inovio has already deployed two different DNA immune activators (IL-12 and IL-28) in human
studies.
WELLNESS
NESTLÉ PURINA SETTLES JERKY LAWSUIT FOR $6.5 MILLION
DVM360, 17 June, 2014
Nestlé Purina PetCare Co. and its Waggin’ Train brand have agreed to a $6.5 million settlement in a lawsuit
brought by pet owners in Illinois in 2012. The company makes jerky pet treats—some manufactured in
China—that have been implicated in a nearly decade-long U.S. Food and Drug Administration (FDA)
investigation into jerky-related illness. Nestlé Purina is not admitting that the treats made pets sick,
however. Bill Salzman, director of corporate communications for the company, says, “There is no indication
the treats negatively impacted the health of dogs; this resolution allows everyone involved to move
forward.” If the U.S. District Court for the Northern District of Illinois approves the agreement, it will
resolve the disputed claims related to Waggin’ Train jerky products and establish procedures for monetary
relief and compensation. If the deal is approved, settlement class members will be able to claim 100 percent
of reasonable economic damages incurred after their pets consumed the implicated jerky treats. Those with
a documented injury, a deceased pet, food purchase claims or health screening claims will be compensated
upon verification. Without documentation, claims are capped at $300. Earlier this year, Nestlé Purina
“relaunched” its Waggin’ Train products, touting changes to its jerky treat supply and production process.
The company stated that it would: > transfer its Chicken Jerky Tenders to a single-source supplier and
manufacturer in China. > place its own quality inspectors at the plant to oversee the production process. >
increase in the testing of products for the presence of Salmonella, melamine and antibiotics. > change its
packaging to include where the meat was sourced and add serving size recommendations.
NESTLÉ OPENS THIRD RESEARCH AND DEVELOPMENT CENTRE IN CHINA
Process & Control Today, 17 June, 2014
Nestlé has officially opened its latest Chinese research and development centre in Dongguan, in Guangdong
province. The centre at Dongguan is a joint venture with Hsu Fu Chi, China’s leading confectionery,
biscuits and traditional snack manufacturer. The new R&D Centre will focus on research in confectionery
and ice cream, building on Nestlé’s global R&D strength in these areas to develop more high-quality
products for consumers across Asia. Johannes Baensch, Nestlé’s Global Head of R&D said, “The
establishment of Nestlé Dongguan R&D Centre will further our understanding of Chinese consumers,
ingredients and local cuisine, and provide scientific and technological expertise to the rest of the business in
Asia and around the world.” Nestlé was among the first multinational companies to invest and build
factories in Dongguan. Its two other R&D centres in China are in Shanghai and Beijing. Each centre
focuses on nutrition and health, targeting consumer needs and conducting research on products,
development, innovation and renovation.
INDUSTRY AND ECONOMY
MNC DRUG COMPANIES LIKE ROCHE, MERCK SERONO, NOVARTIS SEE TOP DECK
RESHUFFLE
Economic Times, 17 June, 2014
Multinational drugmakers including Roche, Merck Serono, Novartis and Bristol Myers Squibs are
witnessing top-level changes in their management in India, with their chief executives exiting the country at
a time when the Rs 72,000-crore market appears to be as challenging as it is potentially lucrative. Lawrence
Ganti, India head of German drugmaker Merck Serono is moving to Brazil to take charge of the company's
business in South America while American drugmaker Bristol Mayers Squibbs' Phiroz Khan is headed for
the United States. Novartis' Anil Matai is leaving the company to go on a sabbatical and Roche's Meeta
Guliyani is moving to Merck Serono in Boston. Ganti, who stayed in India for three years, told ET, "I am
not boasting, but my shift is a reward for a successful transformation of the India business." Merck, the
second fastest growing multinational drugmaker in India according to figures from the All India
Organisation of Chemists and Druggists, is looking for Ganti's replacement. Novartis India, which had a
tough run with the intellectual property laws in India, will also see its chief executive Anil Matai exit after a
decade-long stint with the company. Besides its unsuccessful attempt in getting patent for the anti cancer
drug Glivec, under Matai's leadership Novartis has managed to built a strong business driven by its inroads
into the rural market and a strong portfolio of diabetes drug like Galvus. Matai will be replaced by Jawed
Zia, the former managing director of Alcon, the eye care company which Novartis had acquired in 2010.
INDIA THWARTS BIG PHARMA PUSH AT WHO ASSEMBLY
Times of India, 15 June, 2014
India has successfully thwarted Big Pharma's attempt to influence norm-setting for medicines in the
resolution passed recently at the World Health Assembly in Geneva. India, along with several other
countries, also objected to World Health Organization's involvement with the International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Civil
society organizations working for greater access to medicines are pleased with the initiative. According to
them, "harmonization" was a euphemism for setting of industry-led standards, which favour interests of
transnational pharmaceutical corporationB-and their push to weaken competition from generic medicines.
The original draft has several references to "harmonization of technical requirements for registrations of
Pharmaceuticals for human use" by developing appropriate norms and standards "taking into account the
standards created by existing regional and international" initiatives". India got such references dropped
before the resolution was adopted. "The WHO guidelines are advisory in nature. But if a resolution is
adopted, it becomes binding on the member countries. We cannot be party to a resolution where the
language is not clear. What exactly do you mean by convergence or harmonization of regulation? Who will
harmonize with whom? The needs of different countries are different," said R K Jain, additional secretary in
the health ministry He, with V G So-mani of Central Drug Standards Control Organization, negotiated on
India's behalf.
POLICY TWEAKS IN US SHIFT INDIAN PHARMA'S FOCUS
Business Standard, 18 June, 2014
Indian drug makers may have to revamp their strategies to maintain their grip on the world's largest
pharmaceutical market — the United States. The recent changes in the American law on generic drugs,
many of which are reflected in the functioning of the US Food and Drug Administration, or USFDA, are
likely to impact Indian pharmaceutical companies which clock 40-60 per cent of their consolidated
revenues through exports to that country. The patent laws, changed last year to the first-to-file or FTF
system, awards patents to companies that are first to file for protection of a new product rather than to the
company that first invents a product. An FTF status also allows the company to enjoy the right to 180 days
of exclusive sale in the US. So far, Indian pharmaceutical companies have focused on blockbuster
medicines that are expected to go off-patent in the near future. Their aim has been not only to develop
generic versions of such medicines, but also to win FTF for these and cash in on 180 days of monopolistic
sale. However, now, with the Generic Drug User Fee Act in place, USFDA is looking at gradually reducing
the time taken in evaluation of applications seeking approval to sell the generic version of an off-patent
drug. As a result, more drugs are entering the market at the same time. While this is directly impacting the
market share of companies, it is also seen as a threat to the exclusive marketing rights for off patent drugs.
Of late, the regulator has been granting 180 days of exclusive marketing rights to more than one company.
In effect, this dilutes the advantage of FTF while allowing increased competition. "As it is, once the drug
goes off patent, there is price erosion and the market value declines significantly with the entry of the
generics. With multiple FTFs, there is further disintegration of the market share and an increase in
competition," an industry official explains. For example, in December last year, as many as six companies
received the nod of USFDA to launch the generic version of Eli Lilly's anti-depressant Cymbalta in the US.
The regulator also allowed all six of them to share the 180 days of exclusive marketing rights for the
medicine. Of these, five were leading Indian companies — Aurobindo Pharma, Dr Reddy's Labs, Lupin,
Sun Pharma and Torrent. The sixth was Israel's Teva. According to industry experts, Cymbalta had annual
US sales of S5.43 billion and was one of the largest selling products globally before going off-patent.
However, analysts estimate that once the generic version of the drags reached the market, sales slipped to
$120-180 million. Similarly, the regulator had simultaneously cleared the applications of various companies
such as Dr Reddy's Labs, Sun Pharma and Aurobindo Pharma for their generic version of Sanofi Aventis'
Plavix tablets, which commanded annual sales of around $6.74 billion in the US before its patent expiry. Dr
Reddy's and Teva also received concurrent approval for launching generic version of Zyprexa with
exclusive marketing rights at the same time. However, the respective strengths varied for the companies.
PUBLISHING CLINICAL TRIALS DATA A WELCOME FIRST STEP
Economic Times, 19 June, 2014
Late last week, the European Medicines Agency (EMA) agreed on a policy to publish clinical trials data of
the drugs it approves. The new policy is expected to be finalised soon and to become effective on October 1
this year. It is a major victory for pressure groups that have been fighting for increased transparency in
clinical trials. The rules may still not go far enough, but it is a beginning that will make a difference to
clinical trials all over the world. For all those who participate in clinical trials, it may come as a shock that
the data about their trials may never be published. There is a business reason for it. Companies who sponsor
the trials fear that it might help their competition. That indeed may be the case in some instances, but it also
prevents doctors from making informed choices - if they want to -about the drugs they prescribe. The EMA
has been a pioneer in this regard, but because it came under intense pressure from NGOs. One campaign
called AllTrials, for example, has been fightingfor increased transparency in clinical trials. AllTrials was
started by physician Ben Goldacre, and also involves several prestigious organisations including the
journals BMJ and PLOS. Goldacre's book Bad Pharma set the tone in 2012 for the campaign for open
research. The EMA decision is its first positive outcome. Bad Pharma had argued that the medical system is
broken, as the pharma industry is full of unethical practices. They are far too many to be listed here, but one
issue is important: the industry frequently withholds negative data. Some analyses have shown that there is
only 50 % chance that a specific clinical trial data will be published eventually This should be disturbing to
all the stakeholders (like patients and doctors), but the healthcare regulators all over the world have allowed
this to happen in the name of protecting the business interests of pharma companies. Now that the
Europeans have taken a step forward, the system can hope to change, although some changes will take time.
The EMA will publish the results of trials even if there is no request from anyone to do so. But there are
other concerns, according to the pressure groups.
HELPING PHARMA COMPANIES KEEP TABS ON SALES REPS
The Hindu Business Line, 17 June, 2014
The idea occurred to him when he was consulting for a pharmaceutical company to help it streamline and
monitor the working of its field force. That was when he realised there was no product readily available in
the market. He then developed a solution that was just what the pharma company required. The next step
was why not develop it as a product and market it to other pharm companies that would need to monitor
their field sales personnel. Thus was born SwaaS Systems Pvt Ltd. Swaas in Sanskrit means breath or
oxygen and, the 38-year-old Anand Natraj V, Managing Director, says that is what his start-up wants to be,
especially for companies with field sales personnel.
The company that Anand tried to help out was Curatio based in Chennai, one of the portfolio companies of
Fulcrum Ventures, an early-stage venture capital firm. Fulcrum has also entirely funded the Chennai-based
SwaaS, to the extent of about Rs 4.5 crore. Fulcrum came in as an angel investor and has been there right
from the beginning, says Anand. The first product that SwaaS developed was called Hi Doctor that helps
sales representatives of pharmaceutical companies log in at the end of their day's work and file a report on
the doctors and pharmacists they met and products they talked about to the doctor. The representative logs
in to the company's website and files his or her report using the Hi Doctor facility. "We felt there was a
strong need for a niche solution in the market, which is how we started SwaaS," says Anand. SwaaS
initially focussed on pharmaceutical companies in Chennai and sold the Hi Doctor product to companies
such as TTK, Tablets India and Shield Healthcare. Encouraged by the response, SwaaS then launched it in
Mumbai followed by Ahme-dabad. It now works with 75 pharma companies and over 30,000 sales
representatives.
PHARMA SECTOR POISED FOR HEALTHY GROWTH
Financial Chronicle, 16 June, 2014
PHARMACEUTICAL Industry is well poised to deliver a strong growth, both on the domestic and the
exports markets. While the, domestic market, slowed down in FY2014, due to the new DPCO, going
forward we expect the domestic formulation sales to grow at a CAGR of 13-14 per cent during FY2Q1416E, though FY2015 sales growth could be higher on back of the low base effect. Exports, on the other
hand can easily grow at 17-18 per cent CAGR of FY2014-16E. Thus, the Industry can • easily post a CAGR
of 15-16 per cent during FY2014-16E. The growth in the exports would be driven mainly by the US and
ROW markets, which have been clocking higher growth than other mar- kets. Indian companies still
manage to hold large no of ANDA's in the US and with the merger of the Sun with Ranbaxy, the combined
entity has become one of the largest players in the US markets, being the 5th largest player in the US
generic Industry. We expect the US markets to post a 18-20 per cent CAGR during the period. On the stock
front, we expect an. earnings CAGR of 12 per cnt over FY2014-16E for our universe of stocks, on back of
moderate margin assumptions for the sector. In the generic segment, we prefer Cipla, Lupin, DRL, Sun
Pharmaceuticals and Ipca Labs. In CRAMS, though the segment is currently witnessing some-pressure,
there have been indications of gradual recovery and ramp up from most of the CRAMS players. Thereby,
with the valua-' tions rendering attractive, we recommend Dishman in this segment.
CANCER DRUG SALES GREW FASTEST IN CY13 ON NEW THERAPIES
Financial Express, 16 June, 2014
SALES of cancer drugs grew fastest among all therapeutic categories in CY2013 with the availability of
several new therapies helping to increase awareness and purchases. Cancer drugs, also known as antineoplasties, registered a growth of 24.1% in CY13 to Rs 998 crore but analysts believe the market remains
under-penetrated. Pharma sales across the 19 therapies that constitute the market, however, grew at just 6%
in CY2013, well below the 14 % rise in C Y2012 as the combination of a higher base and adverse policies
impacted business. Hari Natarajan, vice-president, business intelligence at AIOCD Pharma softtech
AWACS, said the market for cancer medication had expanded while biosimilars were gaining ground.
"Many therapies, especially the 'zumabs' — a type of cancer drug — are being launched," Natarajan pointed
out adding that while biosimilars are a relatively new segment, they're clocking increasingly higher sales.
Anti-diabetic medications were the second fastest growing segment last year reporting a rise of 14.2%,
although this was way lower than the 22% seen in CY12. ""There were several'gliptins' — a type of
diabetes drug —launched in 2012 which created a huge base," IDFC Institutional Equities analyst Nitin
Agarwal Agarwal explained. The market share of gliptins is rising steadily with CY2010 sales of about f810 crore growing to about Rsl3-15 crore in C Y2013 and Nataraj an believes the base created by gliptins has
now normalised. Several anti-diabetes molecules have, however, come under price control such as
metformin, a basic diabetes therapy, which has been added to the national list of essential medicines
(NLEM). The growth of the cardiac therapies segment, the second highest-grosser in CY13, more than
halved to 8.5% due to the lower contribution of cardiac drugs with statins or purely statin drugs to the mix.
Pure-play cardiac drugs comprised 82.1% of the cardiac segment with the combination of statins and statin
drugs vying for the rest of the market share. Analysts believe the low base post July last year together with
the normalisation in distribution as also impact from price increases taken from April onwards should help
pharma sales grow 8-10% in the current year. However, they caution that a rebound to the levels of 10%
plus growth seen in FY13 may not happen soon.
ANTI-DIABETIC DRUG TOPS INDIA'S PHARMA SALES
Economic Times, 18 June, 2014
In a grim reminder of the rise of lifestyle diseases, particularly diabetes, an anti-diabetic molecule has for
the first time become the largest-selling formulation in the domestic pharma retail market. The formulation,
which is also the most-prescribed anti-diabetic drug—a combination of glimepiride and metformin
(marketed as Glycomet GP and Gluconorm-G)—has dethroned the popular class of anti-infective
medicines, led by widely-used medicine brands like GSK's Augmentin (a combination of amoxycillin and
clavulanic acid) in May. Widely-prescribed anti-diabetic drugs (glimepiride plus metformin) clocked sales
of Rs 105 crore, surpassing the anti-infective therapy at Rs 103 crore, in the pharma retail market valued at
Rs 6,636 crore, in May this year. Analysts tracking the market said the anti-infective therapy had always
been ranked on top. The primary reason for the anti-diabetic molecule taking the lead is because of its faster
growth, as well as the anti-infective molecule coming under price control. The anti-diabetic sub-class, a
combination of glimepiride and metformin, registered a growth of 34.4% in May, as against a meagre
growth of nearly 4% in the anti-infective amoxycillin and clavulanic acid market, figures culled from
market research firm, AIOCD AWACS said. Interestingly, the anti-infective molecule witnessed a
downward revision in prices over the last few months as it came under price control, with prices declining
by over 9% for the 12-month period ended May 2014, while its volumes grew around 7% in the same
period. As against this, the anti-diabetic sub-group clocked robust sales month on month, posting a volume
growth of 26%, while its prices jumped 6.4% (MAT, May 2014). Not only has the anti-infective sub-group
lost value because of price control, but the anti-diabetic therapy is growing faster, Hari Natarajan VP,
AIOCD AWACS told TOI, adding the overall pharma retail market seemed to be showing signs of revival in
May, with a strong growth registered at 8.1%, as against 5% witnessed in April. In fact, sales of diabetes
molecule have been climbing up over the last few years, and have shown a steady increase month on month
from Rs 97 crore in December. Doctors say that the anti-diabetes combination is widely used as its
affordable and effective.
SPOOKED BY PROBES, PHARMA EXECS THINK OF LEAVING CHINA
Financial Express, 14 June, 2014
CHINA'S crackdown on corruption in the pharmaceutical sector has frightened foreign executives so much
that some fear they could be jailed and have asked their lawyers if they should leave the country for six
months. Others are thinking of going for good. While the crackdown has been building for a year, Chinese
police shocked the foreign business community a month ago when they filed corruption charges against
Mark Reilly former China head of British drugmaker GlaxoSmithKline Pic. The Briton, who has been
barred from leaving China, could face decades in prison. Even before then, executives were getting worried
about a wave of visits from police andregulators to their offices as well as articles in Chinese media alleging
corrupt practices against many global drugmakers. The charges against Reilly had prompted some senior
executives to look at all contingencies, several legal and industry sources said. "Many of our clients are
asking about personal liabilities and insurance, with executives asking if they are put in jail what will
happen to their families and how the company will provide protection for them," said John Huang,
Shanghai-based co-founder and managing partner at law firm M WE China. Police said a year-long
investigation found GSK made billions of yuan from schemes to bribe doctors and hospitals. Two senior
Chinese executives were also charged. Britain'sbiggestdrugmak-er has said the accusations were "deeply
concerning" and that it had zero tolerance for bribery. Reilly has not been reachable for comment while his
lawyer has declined to talk to the media. Reilly's whereabouts are unknown. Global drugmakers contacted
by Reuters declined to comment about the crackdown andhowitwas affecting executive morale in the
world'sthird-largestpharma-ceutical market. But Huang and two pharmaceutical executives said some
managers were reconsidering the legal risks involved in holding any position where they were responsible
for some of the thousands of marketing and sales staff that global firms employ across China. Investigators
have focused on those staff and how they deal with poorly paid doctors and administrators in public
hospitals, the biggest buyers of medicine in China.
ASIA SLOWLY WARMS TO BIOLOGIC DRUGS
Mint, 14 June, 2014
One ongoing concern for people and governments in Asia is the rising cost of healthcare. Every year,
governments spend more on caring for their populations while the people themselves worry that treatments
and drugs could prove to be too expensive. Since the 1990s, one way to lower costs has been to use generic
drugs, which have made some of the most sought-after and expensive medicines in the world much cheaper.
But doing the same with the more complex biologic drugs that arc often seen as the future of medicine may
not be so easy. Nevertheless, companies are betting heavily on the market for bio-similars, and health
authorities are, slowly, making this possible. Across Asia, half a dozen countries already have active
markets and more are on the way. In the United States, generics brought down the price of drugs like the
antidepressant Prozac from $40 per month to $10 per month. Over the last decade, the savings to patients
from the use of generic drugs have risen three and a half times. For emerging markets like much of Asia, the
impact of generics on the pockets of patients has been even greater, particularly for complex and expensive
chemical drugs like the antiretrovirals (ARVs) used to treat HIV/AIDS. In 2007, a one-pill daily dose of the
ARV combination tenofovir and lamivudine cost $613 per year in low-income countries and $1,033 in
lower middle-income ones. The price has fallen 67 percent since then. At the end of 2012, some
governments negotiated a price a little more than $100 for a two-pill combination of the same drugs,
according to humanitarian organization Medecins Sans Frontieres, which tracks prices. Generics are copies
of chemical drugs that can be produced and sold once the patents on the original products run out Patents
last around 20 years, depending on which country grants them. A number of companies, most notably in
India, emerged and expanded globally by producing and distributing generics. Because chemical drugs are
essentially mixtures of chemicals made in factories, the manufacturing process is relatively easy to copy to
create a generic version. Now companies are trying to do the same with the biologic drugs that have
emerged, over the last couple of decades, as the new wave of medicines. But copying biologic drugs is
much harder than chemical ones. In fact, it is almost impossible to make an exact copy: What companies
are producing are types of drugs known as biosimilars. "A similar trend will be seen with biosimilars," said
Christopher Ko, CEO of Samsung Bioepis, during the Bio Korea 2014 event in Seoul last month. Since its
inception in 2012 as a division of the South Korean conglomerate, Samsung Bioepis has sought to emerge
as a global player in biosimilars.
PATENTS
ALNYLAM PHARMA RECEIVES US PATENT COVERING RNAI THERAPEUTICS TO TREAT
HBV INFECTION
Pharmabiz, 16 June, 2014
Alnylam Pharmaceuticals, Inc, a leading RNAi therapeutics company, announced that the United States
Patent and Trademark Office (USPTO) has issued a new patent (US patent no. 8,618,277, or "'277 patent")
in the company's McSwiggen patent estate. The McSwiggen patent estate broadly describes chemical
modifications of RNAi therapeutics needed to achieve "drug-like" properties in siRNA, the molecules that
mediate RNAi. Specifically, the '277 patent includes claims that the company believes are critical for the
development of RNAi therapeutics for the treatment of hepatitis B virus (HBV) infection. This patent is
held exclusively by Alnylam and is not licensed to any third parties. The McSwiggen patent estate
comprises a core component of Alnylam's overall intellectual property (IP) estate for the advancement of
RNAi therapeutics, and was recently obtained through the company's acquisition of Sirna Therapeutics
from Merck. "We are pleased with the USPTO's decision to issue the '277 patent from our McSwiggen
patent family, a key component of the IP estate we recently obtained through our acquisition of Sirna
Therapeutics from Merck. Our '277 patent has broad, sequence-independent claims on chemically modified
siRNAs which we believe are critical for the development and commercialisation of RNAi therapeutics for
the treatment of HBV infection," said Laurence Reid, Ph.D., senior vice president and chief business officer
of Alnylam. "Our IP estate remains a cornerstone in our efforts to advance RNAi therapeutics to patients in
need. In the case of the '277 patent, we intend to maximise the value of this newly issued IP solely through
the advancement of ALN-HBV our GalNAc-conjugated siRNA targeting the HBV genome for the treatment
of HBV infection where we expect to select our Development Candidate by this year's end and to file an
investigational new drug application at or around year-end 2015."
GLIVEC PATENT BATTLE LOSS BEHIND US: NOVARTIS' SHAHANI
Economic Times, 19 June, 2014
Just a year after Swiss drug-maker Novartis lost the patent battle for its anti-cancer drug Glivec, the
company has said it has "moved on" with a focus on new product launches and growing its India business, a
strategy that reinforces the importance of the Indian market for multinational drugmakers despite regulatory
challenges. Over the past year, Novartis India has launched three successful patented drugs and over 12
generic drugs that have helped it expand its presence in the country. "Glivec is behind us. Strategically, all
products which are in the Novartis pipeline and also make a commercial case will be launched in India,"
said Ranjit Shahani, vice-chairman and MD of Novartis India. The largest company in the world by sales,
Novartis has launched products like Galvus for diabetes which has monthly sales of over Rs30 crore,
according to trade data, followed by anti-cancer drug Tasigna and On-brez, an asthma drug. All these drugs
have been successful in India, Shahani said. In April, Novartis acquired the cancer drug business of UK
drugmaker GlaxoSmithkline for $16 billion and sold its animal health business to Eli Lilly for $5.4 billion
as part of its global restructuring. GSK and Novartis plan to float a joint venture to sell their over-thecounter drugs. Novartis may also launch some of GSK's products in India.
POLICY AND REGULATIONS
EMA AGREES POLICY ON PUBLICATION OF CLINICAL TRAIL DATA WITH MORE USERFRIENDLY AMENDMENTS
Pharmabiz, 14 June, 2014
The European Medicines Agency (EMA) Management Board has recently agreed the policy on publication
of clinical trial data, together with more user-friendly amendments proposed by EMA executive director
Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted
as part of marketing authorisation applications, but also give the possibility to download, save and print the
trial data for academic and non-commercial research purposes. In light of discussions at the Board, the
wording of the policy, including practical arrangements for academic and non-commercial research users,
will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014,
and will be effective from 1 October 2014. Importantly, the Agency will ensure that the policy will not
prejudice citizens’ rights under existing access to documents legislation and the new clinical trials
regulation. Since embarking on its plans for the proactive publication of clinical trial data, the Agency has
aimed to achieve the broadest possible consensus among its stakeholders and their often competing views
and interests. After an extensive consultation phase that took place between June and September 2013, the
Agency carried out a second round of targeted consultation in May 2014 that showed broad support for the
policy, but highlighted concerns over the proposed view-on-screen-only access. The Agency’s policy is an
important step forward towards achieving increased transparency in the regulation of medicines in Europe.
It takes the Agency beyond its legal obligations and provides an unprecedented level of access to clinical
trial data that are used as part of decision-making for new medicines. The Board endorsed a proposal for the
creation of an ad hoc
INJETI SRINIVAS NEW NPPA CHAIRMAN
Pharmabiz, 16 June, 2014
Injeti Srinivas, a 1983 batch IAS officer, has taken over as the new chairman of National Pharmaceutical
Pricing Authority (NPPA). He assumed the new charge on 11.06.2014. Srinivas is a graduate in Economics
from SRCC, Delhi University with Master in Business Administration from Strathclyde University, UK. He
belongs to 1983 batch of IAS (Odisha Cadre). Srinivas has wide experience in Government of India as well
as in Government of Odisha. He was Director, looking after FIPB and FDI policy, in the Ministry of
Commerce & Industry, Resident Commissioner, Odisha, New Delhi, Chairman, Odisha State Financial
Corporation, Chairman & MD, Industrial Infrastructure Development Corporation of Odisha (IDCO),
Capacity Development Advisor of UNDP, National Institute Building Programme, Afganistan, Joint
Secretary (Sports) Government of India, Additional Chief Secretary, Housing and Urban Development
Department and Development Commissioner – cum- ACS, Odisha.
REGULATOR TO CHASE DRUG COS ON OVERCHARGING
Hindustan Times, 17 June, 2014
Drug-price regulator, National Pharmaceutical Pricing Authority (NPPA) is set to chase drug majors for
defaulting on penalties imposed for overcharging consumers. The defaulters include Cipla Healthcare,
Lupin Limited, Dr. Reddy's, Cadila and Baxter Pharmaceuticals among many others. NPPA has issued a list
of 1,018 cases, since its inception in 1997 up to March 2014, demanding Rs3,381 crore in penalties. So far
it has recovered only Rs274 crore. NPPA has now decided to look at bigger violations. "We have expedited
the legal process to recover the overcharging penalty amounts. Companies that have to pay penalty of over
Rs10 crore are our major focus now," CP Singh, chairman, NPPA told HT. "Consumers get hurt when
companies over-charge, which is why we are looking at the big price violations," Singh added. While some
of the drug makers did not reply to mails sent by 'HT, most of the companies are not satisfied with the
allegations and have filed cases against the authority in court. "In the past also we have won cases against
the authority. This time also, based on legal advice, we haven't paid the penalties in cases where the
molecules used in the drugs were not the part of price control list," said a Dr. Reddy's Laboratories
spokesperson. Other companies echoed similar concerns. "Baxter has also challenged the demand and the
order has been stayed and the matter is subjudice," said the company.
HEALTH MINISTRY'S NEW BID FOR CANCER DRUG COPY NIXED
The Hindu Business Line, 19 June, 2014
In what should come as relief for US drug major Bristol-Myers Squibb, the Ministry of Commerce has
rejected a fresh proposal by the Health Ministry seeking a compulsory licence for production of a copy of
its patented blood cancer drug, Dasatinib. In its response, the Department of Industrial Policy and
Promotion (DIPP), which is a part of the Commerce Ministry and responsible for such approvals, said the
Health Ministry's arguments did not conclusively prove that a generic version of the medicine was needed.
"We have written back saying that we could not support their proposal as more justification was required," a
DIPP official told BusinessLine. The Health Ministry had proposed that a compulsory licence be given for a
generic version of Dasatinib in January this year and then again in May after the DIPP asked it to specify
why it wanted the Centre to step in. In the second proposal, it said the licence should be granted for 'public
non-commercial use' and the cost of producing the blood-cancer medicine be met through Government
schemes.
PRODUCT APPROVALS
US FDA APPROVES BAYER’S GADAVIST INJECTION AS FIRST MAGNETIC RESONANCE
CONTRAST AGENT FOR EVALUATION OF BREAST CANCER
Pharmabiz, 14 June, 2014
The US Food and Drug Administration (US FDA) has granted approval for a new indication for Bayer
HealthCare's Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the
presence and extent of malignant breast disease. The approval is based on priority review of two, multicentre, Phase 3 studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.
ALERE GETS US FDA CLEARANCE FOR ALERE I INFLUENZA A AND B TEST
Pharmabiz, 18 June, 2014
The US Food and Drug Administration (FDA) has cleared Alere Inc's Alere i Influenza A & B test, the first
and only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. "By
providing the speed of a rapid test with molecular technology, Alere i delivers clinically meaningful and
actionable results to clinicians – enabling them to treat patients more quickly and appropriately," said Avi
Pelossof, Alere global president of infectious disease. The clinical performance of Alere i Influenza A & B
was established in a multi-center, prospective study conducted at eight US trial sites during the 2012-2013
flu season, in which 585 prospective nasal swab specimens, collected from patients presenting with
influenza-like symptoms, were evaluated with Alere i, and compared to viral culture. All specimens
generating discrepant results between the Alere i Influenza A & B test and viral culture were tested using an
FDA cleared RT-PCR assay to confirm influenza status. Molecular testing involves the extraction and
analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of
infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, labaccurate results in less than 15 minutes on a user-friendly platform.
US FDA APPROVES NOVARTIS' HOLLY SPRINGS FACILITY FOR PRODUCTION OF CELLCULTURE INFLUENZA VACCINES
Pharmabiz, 17 June, 2014
The US Food and Drug Administration (FDA) has approved Novartis' manufacturing facility in Holly
Springs, North Carolina for the production of cell-culture influenza vaccines. This is the first US facility of
its kind and is now approved for commercial production. The site will produce seasonal and pre-pandemic
influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic.
Novartis utilizes cell-culture technology to produce Flucelvax (Influenza Virus Vaccine), which was the first
FDA-approved seasonal influenza vaccine not manufactured with chicken eggs. Flucelvax, approved for
individuals 18 years of age and older, does not contain any antibiotics or preservatives. With the licensure
of the Holly Springs facility, Flucelvax will be produced in the US for the first time. "Cell-culture
technology is the first major advancement in influenza vaccine production in the US in more than 40 years.
We are proud to be at the forefront of this innovation, which will allow us to deliver on our public health
and health security commitments," said Andrin Oswald, division head, Novartis Vaccines. "With this awardwinning, state-of-the-art facility, we will be able to not only offer US consumers an antibiotic- and
preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future
pandemic threats." Cell-culture technology offers several potential benefits over traditional influenza
vaccine production, which occurs in chicken eggs.
CLINICAL TRIALS
BASILEA PHARMACEUTICA BEGINS PHASE I COMBINATION STUDY WITH GRAMNEGATIVE ANTIBIOTIC BAL30072 & MEROPENEM
Pharmabiz, 14 June, 2014
Basilea Pharmaceutica Ltd. has initiated a phase 1 clinical study with its gram-negative antibiotic
BAL30072 evaluating the safety, tolerability and pharmacokinetics of multiple-ascending doses of
intravenously administered BAL30072 in combination with meropenem, an antibiotic of the carbapenem
class. Basilea is developing BAL30072 for the potential treatment of infections with multidrug-resistant
Gram-negative bacteria. Gram-negative pathogens account for approximately a third of all hospitalacquired infections and are recognised as a global health threat. In preclinical studies, BAL30072
demonstrated synergistic or additive effects when combined with carbapenem antibiotics. Prof. Achim
Kaufhold, Basilea's chief medical officer, stated: "Based on the recent encouraging preclinical data on the
synergistic or additive effects of BAL30072 and carbapenems we are exploring such combinations in the
clinical setting. We are assessing the safety and tolerability of BAL30072 alone and in combination with
meropenem in preparation for phase 2 development. Combinations with meropenem may add synergistic or
additive coverage to the potent activity of BAL30072 against a broad range of clinically relevant multidrugresistant Gram-negative pathogens, such as Acinetobacter baumannii and Pseudomonas aeruginosa and
other less common pathogens causing serious infections for which there are currently few or no treatments
available." The phase 1 study is designed as a double blind, placebo-controlled, parallel-group study
enrolling healthy female and male adults and randomised to receive multiple-ascending doses of BAL30072
or placebo alone or in combination with meropenem. BAL30072 is an intravenous monosulfactam
antibiotic in phase 1 clinical development with bactericidal activity against infections by multidrug-resistant
Gram-negative bacteria. The investigational drug demonstrated in-vitro and in-vivo coverage of Gramnegative pathogens including multidrug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa
and has robust activity against strains that produce antibiotic-inactivating enzymes such as metallo-betalactamases. BAL30072 has shown synergistic or additive activity with antibiotics from the carbapenem
class. In previous phase 1 studies, the maximum tolerated dose for BAL30072 was determined, with
reversible elevated liver enzyme levels as the dose-limiting factor. In June 2013, Basilea entered a contract
for the development of BAL30072 with the Biomedical Advanced Research and Development Authority
(BARDA) within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for
Preparedness and Response. The contract may provide development funding for BAL30072 of up to USD
89 million.
FERRER BEGINS SECOND PHASE III STUDY OF OZENOXACININ IN ADULTS &
PAEDIATRIC PATIENTS WITH IMPETIGO
Pharmabiz, 14 June, 2014
Ferrer, a privately-held Spanish pharmaceutical company, announces that the first patient has been recruited
into a second phase III trial of Ozenoxacin, formulated as a topical treatment for infectious dermatological
conditions in adult and paediatric patients with impetigo. The study is scheduled to complete in Q1, 2015.
The multicentre, randomised, double-blinded, clinical study comparing Ozenoxacin one per cent cream
versus placebo will be conducted in about 412 patients aged two months and over with a clinical diagnosis
of non-bullous or bullous impetigo at approximately 36 centres in the USA, South Africa, Germany, Spain,
Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals In 2013, Ferrer
successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two
years and over with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream
versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological
endpoints by end of therapy visit. In addition, Ozenoxacin demonstrated a superior bacteriological cure
compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is
safe and very well tolerated in the adult and paediatric populations.
ELI LILLY REPORTS DETAILED RESULTS FROM TWO PHASE III STUDIES TESTING
BOTH DOSES OF DULAGLUTIDE VS INSULIN GLARGINE
Pharmabiz, 18 June, 2014
Eli Lilly and Company released detailed results from two AWARD trials that showed treatment with onceweekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin
glargine, with a lower risk for hypoglycemia. Dulaglutide is an investigational glucagon-like peptide-1
(GLP-1) receptor agonist being studied for the treatment of type 2 diabetes. Results were presented at the
74th American Diabetes Association Scientific Sessions in San Francisco. "Many patients with type 2
diabetes reach a point when oral medicines alone may no longer be effective enough. In these cases, many
healthcare professionals choose to intensify treatment with an injectable medicine," said Francesco
Giorgino, MD, professor of endocrinology and metabolism, University of Bari, Italy. "Data from these two
studies comparing once-weekly dulaglutide with insulin glargine, in combination with other diabetes
treatments, provide important information about a GLP-1 receptor agonist that, if approved, may be
appropriate for patients with type 2 diabetes." Results from the AWARD-2 trial, which evaluated the safety
and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to
combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg
provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated
patients reached target HbA1c levels of less than 7 per cent. Further, once-weekly dulaglutide 0.75 mg was
non-inferior to insulin glargine in reducing HbA1c levels. Both doses of dulaglutide were associated with
sustained weight loss, while insulin glargine showed weight gain. Results from the AWARD-4 trial - the
first phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin - showed
that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior
blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin
glargine and mealtime insulin lispro.
GILEAD REPORTS POSITIVE PHASE 3 DATA FROM ONCE-DAILY FDC
LEDIPASVIR/SOFOSBUVIR TO TREAT GENOTYPE 1 CHRONIC HCV INFECTION
Pharmabiz, 17 June, 2014
OF
Gilead Sciences, Inc., a biopharmaceutical company, announced topline results from a phase 3 clinical trial
(GS-US-337-0113) in Japan evaluating the investigational once-daily fixed-dose combination of the NS5A
inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg,
with and without ribavirin (RBV), for the treatment of genotype 1 chronic hepatitis C virus (HCV)
infection. Among patients receiving 12 weeks of LDV/SOF without RBV, 100 per cent (n=83/83) of
treatment-naïve and 100 per cent (n=88/88) of treatment-experienced patients achieved a sustained
virologic response 12 weeks after completing therapy (SVR12). Among patients receiving LDV/SOF plus
RBV, 96 per cent (n=80/83) of treatment-naïve and 100 per cent of treatment-experienced patients
(n=87/87) achieved SVR12. Across all arms of the study, patients with cirrhosis achieved a 99 per cent
(n=75/76) SVR12. The study met its primary endpoint of superiority compared to a predefined historical
SVR12 rate. Patients who achieve SVR12 are considered cured of HCV infection. Genotype 1 is the most
common strain of HCV in Japan, accounting for approximately 70 per cent of the more than one million
people chronically infected with the disease. The majority of these infections are due to HCV genotype 1b.
Current treatment options for genotype 1 HCV infection involve up to 48 weeks of therapy with pegylated
interferon injections, RBV tablets and other oral medicines, which may not be suitable for certain patients.
“The cure rates observed with LDV/SOF in this study are impressive because they were achieved without
the need for interferon or ribavirin, both of which involve more complex dosing requirements and may be
associated with significant side effects,” said Norbert Bischofberger, PhD, Gilead’s executive vice president
of research and development and chief scientific officer. “These results suggest that a once-daily LDV/SOF
tablet has the potential to be an efficacious and well-tolerated regimen for many HCV patients in Japan.” In
the study, 341 patients with genotype 1 HCV infection were randomized (1:1) to receive 12 weeks of alloral therapy with LDV/SOF, with or without RBV.
BIOSENSORS ENROLLS FIRST PATIENT IN LEADERS FREE JAPAN TRIAL
Pharmabiz, 19 June, 2014
Biosensors International has announced enrollment of the first patient in LEADERS Free Japan, a groundbreaking trial involving BioFreedom, the company's novel polymer and carrier-free drug-coated stent
(DCS). LEADERS Free is the world's first prospective, randomised double-blind clinical trial employing
only a one-month course of dual anti-platelet therapy (DAPT) after implantation of an active stent. The trial
is focussed on patients at high risk of bleeding, and has been designed to confirm that BioFreedom is as safe
as a bare-metal stent (BMS) in this patient group, while delivering the anti-restenotic benefit of a drugeluting stent (DES). LEADERS Free Japan will apply the same principles as LEADERS Free (patient
selection criteria and duration of DAPT), but with just the BioFreedom treatment arm. The objective of
LEADERS Free Japan is to confirm that the safety and efficacy of BioFreedom in Japanese patients is
equivalent to that observed in patients of other ethnicities, as assessed in the active (BioFreedom) arm of
LEADERS Free. Safety is to be measured by the composite of cardiac death, myocardial infarction and
definite/probable stent thrombosis at one year, and efficacy by the incidence of clinically driven target
lesion revascularisation at one year. LEADERS Free Japan aims to enroll 139 patients identified as having a
high risk of bleeding from 12 centres across the country. All patients are being prescribed only one month of
DAPT. The first patient has been enrolled in LEADERS Free Japan by the trial's Principal Investigator, Dr.
Shigeru Saito, Shonan Kamakura General Hospital, Kanagawa, Japan. The trial plans to conduct two years
of follow-up. Patients in both arms of the trial are being prescribed only one month of DAPT. Primary
endpoint data is expected in late 2015. BioFreedom represents the latest development in Biosensors' stent
technology, featuring an abluminal coating of Biolimus A9 (BA9) without the use of a polymer or other
carrier. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with
stents. LEADERS Free Japan will be the first clinical trial ever conducted by Biosensors of a BA9-coated
stent in Japan. In its First in Man ("FIM") study, treatment with BioFreedom demonstrated excellent 12month late lumen loss and sustained safety up to four years, including absence of definite and/or probable
stent thrombosis. BioFreedom received CE Mark approval in January 2013 and is currently available in
select markets. Last month Biosensors announced that they had received conditional IDE approval to
conduct a US-based clinical trial of BioFreedom, designed to collect additional safety and effectiveness data
to support a future pivotal IDE study
MERLION PHARMACEUTICALS COMPLETES RECRUITMENT IN PHASE II CUTI TRIAL
IN GERMANY &POLAND
Pharmabiz, 20 June, 2014
MerLion Pharmaceuticals, has completed the planned recruitment into its Phase II trial in patients
hospitalised with Complicated Urinary Tract Infection, including pyelonephritis (“cUTI”) in Germany and
Poland. The trial is a multi-dose, double-blind, double-dummy, active-control, randomised 3-arm study to
evaluate the safety, tolerability, efficacy and pharmacokinetics of finafloxacin. MerLion expects to report
top-line results from the study by the end of Q3 2014. Mr. David Dally, chief executive officer, of MerLion,
commented, “The study is designed to test the safety and efficacy of different finafloxacin dose regimens
with an “intravenous (“iv”) to oral step-down” option for the treatment of cUTI and pyelonephritis. We
believe that finafloxacin will offer the real possibility of reduced treatment durations and concomitant
shorter stays in hospital, thus improving patient convenience and significantly lowering the costs of
hospitalisation and treatment. Reduced hospitalisation periods should also reduce the risk of nosocomial
infections and of generating drug-resistant strains through extended therapy.” Florian Wagenlehner, M.D.,
Ph.D., Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University Giessen, Germany,
lead investigator of the study stated; “We very much look forward to the results of this exciting study and
anticipate that they will allow us to determine the optimum dosing regimen for Finafloxacin and to confirm
the drug’s potential for use as a short course high dose treatment of patients with cUTI and pyelonephritis."
Finafloxacin is a next generation, highly differentiated, fast acting fluoroquinolone antibiotic with an
excellent safety profile. The antibacterial activity of finafloxacin increases significantly under infection
relevant conditions (i.e. at pH values below neutral). The compound exhibits a very broad spectrum of
activity that covers Gram positive, Gram negative, anaerobic and atypical pathogens.
TWO PHASE III TRIALS OF EMPAGLIFLOZIN/LINAGLIPTIN COMBO TABLET SHOWED
REDUCTION IN BLOOD GLUCOSE LEVELS IN ADULTS WITHT2D
Pharmabiz, 17 June, 2014
Two phase III clinical trials found the investigational combination tablet of empagliflozin and linagliptin
reduced blood glucose levels in adults with type 2 diabetes (T2D), Boehringer Ingelheim Pharmaceuticals,
Inc. (BIPI) and Eli Lilly and Company announced. The findings were presented as late breaking abstracts at
the American Diabetes Association 74th Scientific Sessions. The 24-week primary findings of these two 52week trials compared the combination of empagliflozin and linagliptin with empagliflozin or linagliptin
alone in patients with T2D and moderately elevated blood glucose levels consistent with what is often seen
in clinical practice. "We are encouraged by the reductions in blood glucose levels with the
empagliflozin/linagliptin combination tablet and by the fact that more than half of the 494 adults with type
2 diabetes in these studies were able to achieve blood glucose goals below 7.0 per cent with the
combination," said Christophe Arbet-Engels, vice president, metabolic clinical development and medical
affairs, BIPI. "People with type 2 diabetes must often take more than one medication to adequately control
their blood sugar levels. If approved, this combination tablet with two mechanisms of action that lower A1C
through different pathways in a single pill could be an important treatment option for physicians and
patients." If approved, this investigational combination would bring together the distinct mechanisms of
action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4)
inhibitor for the first time in one tablet. SGLT2 inhibitors remove excess glucose through the urine by
blocking blood glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that
stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor and is being studied
for the reduction of blood glucose levels in adults with diabetes. The emerging SGLT2 inhibitor class
removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Empagliflozin is
being studied in one of the largest clinical registration programs in its class, comprised of more than 10
multinational clinical trials and more than 13,000 adults with T2D.
ONCOBIOLOGICS GETS APPROVAL TO BEGIN PHASE I TRIAL IN EUROPE FOR ONS-3010
BIOSIMILAR VERSION OF HUMIRA
Pharmabiz, 14 June, 2014
Oncobiologics, Inc. has received approval to initiate a phase I clinical trial in Europe for its first biosimilar
molecule, ONS-3010, a highly biosimilar version of the marketed drug, Humira. After reviewing
Oncobiologics’ Clinical Trial Application, the Centrale Commissie Mensgebonden Onderzoek (CCMO), the
Dutch Competent Authority, has provided a Letter of No Objection, and the Independent Ethics Committee
of the Foundation “Evaluation of Ethics in Biomedical Research” has approved a Phase I trial to be
conducted by the Center for Human Disease Researchin Leiden, The Netherlands. The study is expected to
be completed before the end of 2014. “After a very successful development campaign, we are excited to see
our first biosimilar molecule enter thisPhase I study. This represents the culmination of two years of hard
work by our team, as well as proof-of-concept for our biosimilars business model, BioSymphony, which
integrates our world-class CMC and manufacturing capabilities with the external clinical expertise of
inVentiv Health, a top global CRO, and several regionally strong commercial partners around the world,”
commented Oncobiologics founder & chief executive officer, Pankaj Mohan. Aldeyra chief executive
officer, Todd C. Brady added, “As an advisor, I have witnessed the rapid development of Oncobiologics and
am thrilled to see the company take this exciting step. Oncobiologics has built a team of respected industry
leaders within the framework of an agile startup. It is a testament to that team that Oncobiologics has been
able to satisfy the challenging regulatory hurdles surrounding the development of complex mAb
biosimilars. I look forward to the successful completion of this trial as well as the continued advancement
of other potential products in the Oncobiologics pipeline.” Oncobiologics is developing several additional
biosimilars, including a biosimilar version of Avastin, which will be filed for its first clinical trial later in
2014. Oncobiologics is also pursuing biosimilar versions of Herceptin, Rituxan and Erbitux with plans to
initiate studies in 2015 and thereafter. Oncobiologics is a privately-held biopharmaceutical company
developing a pipeline of biosimilars and next generation biotherapeutics. Formed by a team of leading
industry experts from firms such as Eli Lilly, Bristol-Myers Squibb, Amgen, Genentech, Merck and Pfizer,
Oncobiologics operates from a state-of-the-art 35,000 sq. ft. fully integrated R&D and Manufacturing
facility in Cranbury, NJ.
SENHWA BIO BEGINS PHASE 1B/2 TRIAL OF CX-4945 IN COMBO WITH GEMCITABINE &
CISPLATIN
Pharmabiz, 18 June, 2014
Senhwa Biosciences, Inc. has initiated a randomised phase 1b/2 Trial of CX-4945 in combination with
gemcitabine and cisplatin for the frontline treatment of patients with bile duct cancers
(cholangiocarcinoma). This Proof-of-Concept trial will study the use of CX-4945, a small molecule CK2
inhibitor, to suppress DNA repair mediated resistance and boost the efficacy of the widely used
chemotherapy agents. “We are delighted to be conducting a phase 2 trial in frontline patients with
cholangiocarcinoma, a population with poor prognosis and limited treatment options. Bile duct cancers are
increasing in prevalence globally, and are of particular significance and concern in emerging Asian
markets,” stated Dr. Tai-Sen Soong, president of Senhwa Biosciences. “This Proof-of-Concept study is
designed to evaluate the combination of CX-4945 with DNA damaging chemotherapy agents. Positive
results in this orphan indication may propel the development of CX-4945 toward similar combination
chemotherapies in additional solid tumour indications, such as breast, lung and bladder cancers, with
greater incidence and substantial markets.” The clinical trial has been initiated at the Mayo Clinic Cancer
Center, Scottsdale, AZ where Dr. Mitesh Borad M.D., director, phase I drug development is global Principal
Investigator of the CX-4945 cholangiocarcinoma study. The multi-centre Phase 2 trial will initially assess
the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin,
followed by a randomised study that compares anti-tumour activity in cholangiocarcinoma patients
receiving either the standard of care gemcitabine plus cisplatin, or CX-4945 combined with gemcitabine
plus cisplatin.
IROKO PHARMA'S PHASE 3 STUDY OF SOLUMATRIX MELOXICAM DEMONSTRATES
SIGNIFICANT EFFICACY AT 30% LOWER DOSES IN OSTEOARTHRITIS TREATMENT
Pharmabiz, 16 June, 2014
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science
of analgesia, will present phase 3 results that showed osteoarthritis (OA) patients treated with
investigational SoluMatrix meloxicam 5 mg and 10 mg, a low dose nonsteroidal anti-inflammatory drug
(NSAID), reported significantly greater pain relief compared with placebo1. These data are being presented
at the 2014 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology
in Paris, France. “Osteoarthritis is one of the most common causes of disability2, and inadequate pain
control can lead to joint stiffness that may impair mobility for patients,” said Dr. Roy Altman, Professor of
Medicine in Rheumatology at UCLA and lead study author. “Clinicians have an urgent need for new
osteoarthritis treatments that can offer reduced systemic exposure when taken over a long period of time,
while also helping to restore some of the loss of function due to the nature of this chronic condition. These
data show SoluMatrix meloxicam represents an important new step forward in fulfilling the unmet need for
effective low dose treatment options for osteoarthritis.” In this Phase 3, multi-centre, double-blind and
placebo-controlled study, 403 patients aged 40 and older with a clinical diagnosis of OA of the knee or hip
were randomized to receive treatment with once-daily SoluMatrix meloxicam 5 mg, SoluMatrix meloxicam
10 mg, or placebo. The primary efficacy endpoint of the study was the mean change from baseline in the
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at week
12. Secondary efficacy endpoints included the Patient Global Impression of Change (PGIC), a patient
reported outcome measure, as well as the amount of rescue medication (acetaminophen) used by each
patient. At week 12, patients treated with SoluMatrix meloxicam 5 mg (P = 0.0005) and 10 mg (P = 0.0059)
achieved significantly greater pain relief as measured by the WOMAC pain subscale score compared with
patients receiving placebo1.
PHASE 3 STUDY SHOWS EFFICACY & SAFETY OF VICTOZA TO TREAT TYPE 2 DIABETES
IN ADULTS WITH MODERATE RENAL IMPAIRMENT
Pharmabiz, 16 June, 2014
Data from a new phase 3 study demonstrated that once-daily Victoza (liraglutide) provided greater
glycaemic control versus placebo with no worsening of renal function in adults with type 2 diabetes and
moderate renal impairment. The data were presented at the 74th Annual Scientific Sessions of the American
Diabetes Association (ADA) in San Francisco, California. Renal impairment is one of the more challenging
and common long-term complications of diabetes and limits the use of available antidiabetic treatment
options. The 26-week, double-blind, randomised, controlled study investigated the efficacy and safety of
Victoza compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a
combination thereof. The study showed that adults with type 2 diabetes and moderate renal impairment,
defined as those with stage 3 chronic kidney disease (estimated glomerular filtration rate [eGFR] 30-59
ml/min/1.73 m2; Modification of Diet in Renal Disease [MDRD]), treated with Victoza had significantly
greater improvements in mean HbA1c (a measure of blood glucose levels) (-1.05% vs -0.38%; ETD -0.66%
[-0.90;-0.43] p<0.0001), were more likely to achieve the target level of HbA1c <7% (52.8% vs 19.5%;
p<0.0001) and experienced significantly greater weight loss from baseline (-2.41 kg/5.31 lbs vs -1.09
kg/2.40 lbs; ETD -1.32 kg [-2.24;-0.40] p=0.0052) versus placebo. No worsening of renal function and a
lower incidence of hypoglycaemia with treatment of Victoza compared with placebo were observed in the
study. "Renal impairment is very common in patients with type 2 diabetes, especially in adults over 65
years of age", said Melanie Davies, professor of Diabetes Medicine and honorary consultant, Diabetes
Research Centre, University of Leicester, UK. "Of the therapies available for type 2 diabetes, it is essential
we have treatment options specifically for patients with associated renal impairment." The most common
adverse events (AEs) seen in this study were gastrointestinal. These included nausea (21.4% vs 4.4%
placebo), vomiting (12.1% vs 2.2%), diarrhoea (7.1% vs 2.9%) and constipation (5.7% vs 1.5%). Additional
frequent AEs (?5%) were renal impairment (5% vs 5.8% placebo), nasopharyngitis, usually referred to as
the common cold (5% vs 11.7%), headache (5% vs 2.9%), increased lipase (15% vs 8.8%) and decreased
GFR (6.4% vs 5.1%). The phase 3 study was a multinational study involving 277 adults. People with
moderate renal impairment were defined as those with stage 3 chronic kidney disease (eGFR 30-59).
Participants were randomised to either Victoza (liraglutide) 1.8 mg, the highest dosage available, or placebo
as add-on to existing oral antidiabetic treatment and/or insulin therapy. The mean age of participants was 68
and 66.3 years for people treated with Victoza or placebo, respectively. The primary endpoint was
percentage change in HbA1c from baseline.
CONVERGENCE ANNOUNCES POSITIVE DATA FROM PHASE II TRIAL OF NOVEL
SODIUM CHANNEL BLOCKER CNV1014802 IN PATIENTS WITH TGN
Pharmabiz, 17 June, 2014
Convergence Pharmaceuticals Holdings Limited (Convergence), an independent biotechnology company,
announces positive data from the phase II clinical trial of novel sodium channel blocker CNV1014802 in
patients with trigeminal neuralgia (TGN), a very severe form of facial pain. CNV1014802 is a novel small
molecule state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav1.7
sodium channel. Following an initial 21 day open-label treatment period with CNV1014802 at a dose of
150mg three times a day (tid), patients who showed a successful response in the final week of the period,
defined as a 30% or more reduction in numbers of paroxysms, or severity of paroxysms, relative to the runin period, were then randomised to a 28 day double-blind treatment period with either CNV1014802 150mg
tid or placebo. All patients entering the study had to have a pre-specified number of paroxysmal attacks of
at least moderate severity. A total of 67 patients were recruited into the study and 69% of those patients
completing the open label period were randomised as clear responders into the double-blind phase of the
study. The novel design of this study protocol has been published and is available online: CNV1014802 was
well tolerated and the study showed a consistent reduction of pain severity and number of paroxysms in all
primary and secondary outcomes. In the primary endpoint of the study there was a treatment failure rate of
just 33% for CNV1014802 vs 65% for placebo and a favourable separation from placebo on the Kaplan
Meier time to relapse. CNV1014802 showed a 2.3 unit decrease in the NRS scale for pain intensity, 60%
reduction in paroxysms vs. 12% in placebo and pain severity dropped by 55% vs. 18% placebo, by the end
of the study. There were no serious adverse events related to the drug and the adverse event profile of the
drug was similar to placebo in the double blind phase of the study. The full study will be published at the
International Association for the Study of Pain (IASP) World Congress of Pain, Buenos Aires in October
2014. CNV1014802 received orphan-drug designation from the US Food and Drug Administration in July
2013 and Convergence will utilise these data to design a pivotal clinical study to start in early 2015 with a
view to commercialising an orphan drug as soon as possible. This is the first well powered, randomized and
placebo controlled clinical trial to demonstrate efficacy of a selective state dependent Nav1.7 inhibitor in a
chronic pain indication.
RESEARCH
TYPE 2 DIABETES DRUG MIGHT ALSO AID WEIGHT LOSS
DNA, 17 June, 2014
Adults who are overweight, obese or have type 2 diabetes might be able to benefit from Danish-made
Victo-za, which, in its third phase of clinical trials, proved successful in weight management. Its chemical
name is liraglutide and when given in 3mg doses over a 56-week period, combined with proper diet and
exercise. Smaller doses of the drug led to a slightly reduced mean weight loss of 4.6 percent and the control
group's mean weight loss was just two percent. All three groups followed a low calorie diet and exercise
regimen for the duration of the study. According to Dr. Maria Collazo-Clavel, an associate professor at
College of Medicine, Mayo Clinic and medical editor of diabetes content on Mayo's health information
website says that the drug delays the passage of food from the stomach to the small intestine, increasing the
amount of time in which the patient is satiated. If approved for use as a weight loss medication, the drug
could serve an important patient group. "Weight loss and weight management are generally much harder for
people who are overweight or obese and who also have type 2 diabetes," said Dr. Robert Kushner, Clinical
Director, Northwestern Comprehensive Center on Obesity, Chicago. "Given the challenges faced by this
patient population, the 5.9% weight loss seen with liraglutide 3 mg in this study is impressive. Another
positive result of the study was the reduction in blood glucose of 1.3 percent in the group that received
liraglutide in the 3mg doses. Some side effects, mostly gastro-intestinal complications such as nausea, were
reported.
DEPRESSED ELDERLY AT ALZHEIMER’S RISK
Times of India, 15 June, 2014
A new study has revealed that depression builds up beta-amyloid plaque in the brain that could cause
Alzheimer's in aged people. Many people develop depression in the latest stages of life, but until now
doctors had no idea that it could point to a build up of a naturally occurring protein in the brain called betaamyloid, a hallmark of Alzheimer's disease. Alzheimer's disease is a currently incurable neurodegenerative
disease with marked protein aggregates including beta-amyloid and tau. The disease begins developing
years before noticeable cognitive decline and memory loss. On the other hand, depression has been proven
to have its own neurodegenerative effects on the brain, but the researchers have found an undeniable
connection between beta-amyloid in depressed elderly patients with cognitive deficits and advancement to
Alzheimer's disease. Axel Rominger, MD said that the results clearly indicate that mild cognitively
impaired subjects with depressive symptoms suffer from elevated amyloid-levels when compared with nondepressed individuals. Alzheimer's disease is the most prevalent form of dementia. It is estimated that 44.4
million people are living with dementia worldwide and this number is expected to increase to
approximately 75.6 million in 2030.
URBAN NOISE CAN TRIGGER OBESITY, HEART DISEASE
Times of India, 16 June, 2014
Are you living in the vicinity of a busy highway or an airport or even a hospital? Constant noise emanating
from heavy city traffic, industrial machinery, aeroplanes and loud music may leave one at a higher risk of
obesity and cardiovascular diseases. In a four-year project, researchers from Karolinska University in
Sweden found that the louder the traffic noise, the greater the increase in people's waist size. "There was
nearly a centimetre increase for every 10-decibel rise in the noise levels," the study authors noted. The
effects of noise pollution are even felt by babies in the womb. "We are gathering more and more evidence
that noise in the environment can have a direct effect on health,' said professor Adrian Davis, one of the
authors of the study that appeared in the journal Lancet. Noise pollution affects stress hormones including
cortisol which raises likelihood of pounds packing on around the waist. This visceral fat also pushes up
heart attack risk. In another study, researchers from Utrecht University in the Netherlands examined data
from more than 68,000 births. They found that for every six-decibel increase in traffic noise, there was a
drop of 15g to 23g in birth weight. Low birth weight is linked to a range of long-term health problems,
including high blood pressure, diabetes and heart disease. It also affects school children's academic
performance, researchers said.
POST-MENOPAUSAL WOMAN AT RISK OF HEART DISEASES
Times of India, 16 June, 2014
A staggering 43 million Indian women are affected by heart disease, with one in every three women dying
of the condition as against one in 31 from breast cancer and experts say that it is post-menopausal women
who are at a greater risk. Tapan Ghose, director and head of department of cardiac sciences at Paras
Hospitals, said that in 2012, 56 percent of women identified heart disease as the leading cause of death
compared with 30 percent in 1997. "India is considered the cardiac as well as the diabetic country of the
world. It has been estimated that 60 percent of the Indian population is suspected to be suffering from some
cardio-vascular disease. Ninety percent of women have one or more risk factors for developing heart
disease," Ghose told us. "While one in 31 Indian women die of breast cancer each year, one in three dies of
heart disease," he added. Agreeing with Ghose, N.N. Khanna, senior consultant, cardiology at Indraprastha
Apollo hospital, said that post-menopausal women are at greater risk as compared to their male
counterparts. "Once they develop a cardiac disease, chances are they might face death due to it. We do not
have real statistics in India; but death toll is higher in India since women are prone to diabetes," Khanna
told us. Women are more susceptible to cardiac ailments after menopause since their natural protection
wears off, he added. According to Deepak Khurana, director of cardio thoracic and vascular surgery at
Rockland Hospital, Manesar, urbanization of society, stress level, smoking, consumption of alcohol and
lack of physical work are some of the main reasons for the growing trend. Anil Bansal, chief cardiologist at
Columbia Hospital, Gurgaon, said that diabetes, hypertension and obesity are equally responsible. "With
changed patterns in urban culture, the trend of smoking and excessive alcohol has increased among women,
making them vulnerable to heart diseases. Cardiovascular diseases are also rising due to affluence with
which there is increased dependence on junk food, leading to rising heart conditions," Bansal told IANS.
"Along with high cholesterol, obesity, reduced physical activity combined with over-nutrition, increase in
smoking and alcohol consumption and sedentary or moderate lifestyle," he added.
'NICOTINE GUMS TOO MAY CAUSE CANCER'
Times of India, 17 June, 2014
Nicotine patches may have helped many to kick the butt, but these can be equally dangerous as smoking as
nicotine itself is carcinogenic, a new study shows. Nicotine is such a powerful carcinogen that nicotineinfused products designed to help people give up smoking may not be safe, the findings showed. Nicotine is
one of 4,000 chemicals found in cigarette smoke. While many of these chemicals are recognised as
carcinogens, nicotine has, until now, only been considered addictive rather than carcinogenic. Nicotine
exposure causes thousands of mutations in a cell's DNA and this could be a precursor to cancer. "These
results are important," Harold Garner from Virginia Bioinformatics Institute in the US was quoted as
saying. "This is because for the first time they directly measured large numbers of genetic variations caused
only by nicotine, showing that nicotine by itself can mutate the genome and initiate cancer," Garner added.
PROCESSED RED MEAT UPS HEART FAILURE RISK
Times of India, 18 June, 2014
Love ham or salami for your breakfast daily? Better cut down the intake for the health of your heart. An
alarming research indicates that men who regularly eat moderate amounts of processed red meat such as
cold cuts (ham/salami), sausage, bacon and hot dogs are at higher risk of heart failure and death. Processed
meats are preserved by smoking, curing, salting or adding preservatives. "Processed red meat commonly
contains sodium, nitrates, phosphates and other food additives, and smoked and grilled meats also contain
polycyclic aromatic hydrocarbons, all of which may contribute to the increased heart failure risk," claimed
Alicja Wolk, a professor from the Institute of Environmental Medicine at Karolinska Institutet in
Stockholm, Sweden. Unprocessed meat is free from food additives and usually has a lower amount of
sodium, Wolk added. "To reduce your risk of heart failure and other cardiovascular diseases, we suggest to
avoid processed red meat and limit the amount of unprocessed red meat to one to two servings per week or
less," explained Joanna Kaluza, an assistant professor at Warsaw University of Life Sciences in Poland.
"Eat a diet rich in fruit, vegetables, whole grain products, nuts and increase your servings of fish," Kaluza
added. To reach this conclusion, researchers analysed a cohort of Swedish Men study that included 37,035
men 45-79 years old with no history of heart failure. Participants completed a questionnaire on food intake
and other lifestyle factors in 1998. After almost 12 years of follow-up, researchers found that heart failure
was diagnosed in 2,891 men and 266 died from heart failure. Men who ate the most processed red meat (75
grams per day or more) had a 28 per cent higher risk of heart failure compared to men who ate the least (25
grams per day or less) after adjusting for multiple lifestyle variables. Men who ate the most processed red
meat had more than a two-fold increased risk of death from heart failure compared to men in the lowest
category. For each 50 gram (1-2 slices of ham) increase in daily consumption of processed meat, the risk of
heart failure incidence increased by eight percent and the risk of death from heart failure by 38 per cent,
researchers noted. The risk of heart failure or death among those who ate unprocessed red meat did not
increase. Researchers said they expect to find similar associations in a current study conducted with
women. "For people who eat meat, choose lean meats and poultry without skin and eat fish at least twice a
week - preferably fish high in omega-3 fatty acids such as salmon, trout and herring," researchers concluded
in an American Heart Association journal Circulation: Heart Failur
AVOCADO DIET CUTS HEART RISK IN OBESE
Times of India, 19 June, 2014
Researchers are exploring the potential effects of Hass avocado consumption on emerging cardiovascular
disease (CVD) risk factors. The research was based on a clinical study that investigated whether eating one
Hass avocado every day as part of a moderate fat diet (34 percent fat) had a beneficial effect on risk factors
for CVD among healthy overweight and obese subjects, compared to a similar moderate fat diet without
avocados, and a lower fat diet. The researchers, Li Wang, PhD Candidate, Pennsylvania State University,
and primary investigator, Penny Kris Etherton, PhD, RD, found that relative to baseline, although all three
diets lowered LDL cholesterol (LDL-C), only the avocado diet significantly decreased low density
lipoprotein particle number (LDL-P); there was no significant change in LDL-P with the moderate fat diet
without avocado or the low fat diet. Researchers also observed that the avocado diet significantly lowered
small, dense LDL cholesterol (a more atherogenic subclass of LDL) and oxidized LDL (atherogenic
modified LDL particle). The study was supported by the Hass Avocado Board (HAB) and was also
nominated as one of five finalists for the Clinical Emerging Leader Award Competition. "As new research is
published on CVD risk factors, we're learning that it may not simply be the level of LDL cholesterol that
matters, but rather the particle number, size, density and especially oxidative modification of the LDL
particles," said Penny Kris-Etherton, Distinguished Professor of Nutrition at the Pennsylvania State
University. "Research is beginning to show that small, dense LDL particles, in particular, may be more
likely to be oxidized and form plaques in the arteries compared to large, buoyant LDL particles." Wang said
that their findings show that there is something unique about the avocado beyond its MUFA content that
helped to specifically decrease small, dense LDL in healthy overweight and obese adults.
LIFESTYLE DISEASES HITTING YOUNG URBAN MEN: SURVEY
Western Times, 18 June, 2014
Lifestyle diseases like diabetes and high cholesterol are now hitting more young men in metropolitan cities
of India, says a new survey released here Monday on the occasion ofWorld Men's Health Week. Despite
rising awareness, more than half of the men in major cities like Delhi, Mumbai, Ahmedabad and Chennai
suffer from diabetes,according to a sur-' vey by Metropolis Healthcare. Of the 38,966 samples screened
during June 9-15,56.81 percent reported high diabetes levels. Over 41.48 percent of the samples were in the
age group of 20-40, indicating an increasing trend of. younger population getting hit by diabetes. , In
another sample of 35,886 males, the survey found 8.21 percent with high cholesterol levels and 23.01
percent in the same age group with growing rate of cholesterol. High diabetes levels are usually associated
with age, but other factors like body mass index, stress, family history of the disease, lack of physical
activity etc.also significantly add to the problem. Moreover, both diabetics and high-cholesterol patients are
highly risk-prone to cardiovascular dis-, eases besides other major health problems. The study suggested
that besides regular sc'reen-ings, people should go for preventive measures like reducing obesity, increasing
physical activity, decreas-ing salt intake, among others. The study also unveiled a worrying trend of
prostrate cancer." Of 20,054 samples tested for it, 4,064 samples showed marginally high risk of prostrate
cancer. "Individuals have become more aware of the fact that heart disease is not just a,disease of the
elderly and are now a lot more determined to go a long way v in combating this disease.
SOON, AN ANTI-DEPRESSANT WITHOUT SIDE EFFECTS
Times of India, 19 June, 2014
In a ray of hope for people suffering from depression, researchers have identified a compound that may
treat depression just as effectively as the psychoactive drug ketamine without the unwanted side effects
associated with it. The compound hydroxynorketamine (HNK) produces the same beneficial effects
attributed to ketamine without its unwanted side effects, a new research showed. "The clinical use of
ketamine therapy for depression is limited because the drug is administered intravenously and may produce
adverse effects such as hallucinations and sedation to the point of anaesthesia," said Irving Wainer, a senior
investigator from the National Institute on Aging in the US. "We found that the HNK compound counters
depressive symptoms but it does not cause sedation as in the case of ketamine. "It makes HNK an attractive
alternative as an anti-depressant in humans," Wainer noted. In the study, researchers examined the effects of
intravenous doses of ketamine, HNK and another compound produced by ketamine metabolism known as
norketamine in brains of rats. They found that the compound HNK, like ketamine, not only produced potent
and rapid anti-depressant effects but also stimulated neuro-regenerative pathways and initiated the regrowth of neurons in rats' brains. Surprisingly, HNK was also found to reduce the production of D-serine - a
chemical found in the body whose over-production is associated with neuro-degenerative disorders such as
Alzheimer's and Parkinson's diseases. The use of HNK can also serve as a future therapeutic approach to
treat neuro-degenerative disorders such as Alzheimer's and Parkinson's diseases.
NEW AND GENERIC DRUG APPROVALS
US FDA site
Drug Name
Strength
Dosage Form /
Route
Injectable;Injection
Marketing
Status
Discontinued
Company
Saizen
6mg/Vial; 4mg/Vial
Saizen
Injectable;Injection
Prescription
Emd Serono
Bio-Tropin
5mg/Vial;
8.8mg/Vial
4.8mg/Vial
Injectable;Injection
Discontinued
Ferring
Tev-Tropin
5mg/Vial
Injectable;Injection
Prescription
Ferring
Nutropin Aq
10mg/2ml
(5mg/Ml);
5mg/2ml
(2.5mg/Ml);
20mg/2ml
(10mg/Ml);
10mg/2ml
(5mg/Ml)
6mg/Vial;
5mg/Vial; 4mg/Vial
8.8mg/Vial
Injectable;Injection
Prescription
Genentech
Injectable;Injection
Prescription
Emd Serono
Injectable;Injection
Discontinued
Emd Serono
Injectable;Subcutane
ous
Suspension;Oral
Discontinued
Emd Serono
Noxafil
6mg/0.5ml
(6mg/0.5ml)
40mg/Ml
Prescription
Schering
Daptomycin
500mg
Injectable;Injection
Hospira Inc
Technescan
N/A
Injectable;Injection
None (Tentative
Approval)
Prescription
Beconase Aq
Eq 0.042mg
Diprop/Spray
0.05mg/Spray
Spray, Metered;Nasal
Prescription
Glaxosmithkline
Spray, Metered;Nasal
Prescription
Glaxosmithkline
Flovent Diskus
100
Flovent Diskus
250
Flovent Diskus 50
0.1mg/Inh
Powder;Inhalation
Prescription
Glaxo Grp Ltd
0.25mg/Inh
Powder;Inhalation
Prescription
Glaxo Grp Ltd
0.05mg/Inh
Powder;Inhalation
Prescription
Glaxo Grp Ltd
Ventolin Hfa
Eq 0.09mg
Base/Inh
0.1mg/Inh; Eq
0.05mg Base/Inh
0.25mg/Inh; Eq
0.05mg Base/Inh
Aerosol,
Metered;Inhalation
Powder;Inhalation
Prescription
Glaxo Grp Ltd
Prescription
Glaxo Grp Ltd
Powder;Inhalation
Prescription
Glaxo Grp Ltd
Serostim
Serostim
Serostim Lq
Flonase
Advair Diskus
100/50
Advair Diskus
250/50
Emd Serono
Mallinckrodt
Advair Diskus
500/50
Exalgo
Powder;Inhalation
Prescription
Glaxo Grp Ltd
Tablet, Extended
Release;Oral
Injectable;Iv
(Infusion)
Prescription
Discontinued
Mallinckrodt
Inc
Novartis
Injectable;Iv
(Infusion)
Prescription
Novartis
Aerosol,
Metered;Inhalation
Prescription
Glaxo Grp Ltd
Aerosol,
Metered;Inhalation
Prescription
Glaxo Grp Ltd
Injectable;Iv
(Infusion)
Spray, Metered;Nasal
Prescription
Novartis
Veramyst
0.5mg/Inh; Eq
0.05mg Base/Inh
8mg; 12mg; 16mg;
32mg
Eq 4mg Base/Vial
**Federal Register
Determination That
Product Was Not
Discontinued Or
Withdrawn For
Safety Or Efficacy
Reasons**
Eq 4mg Base/5ml;
Eq 4mg
Base/100ml
0.045mg/Inh; Eq
0.021mg Base/Inh;
0.115mg/Inh; Eq
0.021mg Base/Inh;
0.23mg/Inh; Eq
0.021mg Base/Inh
0.22mg/Inh;
0.11mg/Inh;
0.044mg/Inh
Eq 5mg
Base/100ml
0.0275mg/Inh
Prescription
Glaxosmithkline
Altabax
1.00%
Ointment;Topical
Prescription
Glaxo Grp Ltd
Micronor
0.35mg
Tablet;Oral-28
Prescription
Janssen Pharms
Pitocin
Injectable;Injection
Prescription
Par Sterile
Products
Capsule;Oral
Prescription
Ring;Vaginal
Prescription
Tablet;Oral
Discontinued
Glaxo
Wellcome
Organon Usa
Inc
Hoffmann La
Roche
Boniva
10usp Units/Ml
(10usp Units/Ml);
100usp Units/10ml
(10usp Units/Ml);
500usp Units/50ml
(10usp Units/Ml)
Eq 0.25mg Base;
Eq 1mg Base
0.015mg/24hr;
0.12mg/24hr
Eq 2.5mg Base
**Federal Register
Determination That
Product Was Not
Discontinued Or
Withdrawn For
Safety Or Efficacy
Reasons**
Eq 150mg Base
Tablet;Oral
Prescription
Truvada
200mg; 300mg
Tablet;Oral
Prescription
Hoffmann La
Roche
Gilead
Boniva
Eq 3mg Base/3ml
Prescription
Roche
Vpriv
400 Units/Vial
Prescription
Vpriv
200 Units/Vial
Injectable;Intravenou
s
Injectable;Iv
(Infusion)
Powder;Iv (Infusion)
Merrem
1gm/Vial;
500mg/Vial
Injectable;Injection
Prescription
Shire Human
Genetic
Shire Human
Genetic
Astrazeneca
Zometa
Zometa
Advair Hfa
Flovent Hfa
Reclast
Hycamtin
Nuvaring
Boniva
Discontinued
Chlorothiazide
Sodium
Oxaliplatin
Bloxiverz
Acyclovir
Eq 500mg
Base/Vial
50mg/10ml
(5mg/Ml);
100mg/20ml
(5mg/Ml)
5mg/10ml
(0.5mg/Ml);
10mg/10ml
(1mg/Ml)
5.00%
Injectable;Injection
Prescription
Injectable;Iv
(Infusion)
Prescription
Solution;Intravenous
Prescription
Eclat Pharms
Llc
Ointment;Topical
Prescription
Amneal Pharms
***
Mylan
Institutional
Jiangsu Hengrui
Med