May 31 – June 7, 2014
CORPORATE
GLENMARK OPENS NEW MANUFACTURING FACILITY IN SWITZERLAND
Economic Times, 4 June, 2014
DELHI: Glenmark Pharmaceuticals today opened a new manufacturing facility in Switzerland for supply of
clinical trial material. Glenmark Pharmaceuticals S.A (GPSA), a wholly-owned subsidiary of the company
has opened its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de- Fonds,
Switzerland, Glenmark Pharma said in a statement. "This manufacturing facility supplements Glenmark's
existing in-house discovery and development capabilities and will supply material for clinical
development," it added. Glenmark Pharma Biologics-President Michael Buschle said: "We have been doing
cutting edge work in the area of novel monoclonal antibodies and have several monoclonal antibody
candidates & bispecific antibodies in the pipeline. The manufacturing facility would help us bring these
antibodies to the clinic faster..." An antibody is a protein produced by plasma cells that is used by the body's
immune system to identify and neutralise foreign particles such as bacteria and viruses. The focus for the
biologics R&D centre is to develop novel biologic entities for the treatment of pain, oncologic,
inflammatory and respiratory conditions, Glenmark Pharma said. Since its inception around 10 years back,
Glenmark's biologics research centre has filed several patents on novel biologic entities, it added. "GBR
500, its most advanced candidate has been licensed to Sanofi and is currently in Phase II development.
GBR 900, a first-in-class molecule for treatment of chronic pain is currently in Phase I and GBR 830, an
anti OX-40 antagonist, is scheduled to enter the clinic later this year," it said. The Glenmark Pharma scrip
was trading at Rs 539.90, down 0.03 per cent, on the BSE in the afternoon.
SUN PHARMA IN $400 M DEAL TO SUPPLY GENERICS AT DISCOUNT
DNA, 31 May, 2014
Pharma major Sun Pharmaceutical Industries said it would supply generics at discounted costs to a third
party for an upfront $400 million in order to manage its cash flow and debt better. Sun Pharma founder and
managing director Dilip Shanghvi, in an earnings call, said, "We did this deal to manage our cash flow and
debt in a better manner. The $400 million comes to us offhand but this has nothing to do with our fiscal
2015 guidance." Shanghvi said the deal may see a drop in the topline. Margins will not be impacted, he
said. Under a settlement of a patent dispute case with Pfizer in the US last year over the latter's acid reflex
brand Pro-tonix, Sun had agreed to pay the multinational $550 million. According to analysts, though Sun
had made its provisions, the $400 million will help it to improve cash flow. "Sun will get $400 million
offhand for its supply of possibly a mixed portfolio of generics to the third party at discounted rates. This
will help in managing its cash flow and debt," said pharma analyst Bino Pathiparampil of IIFL. "The
contract is possibly for mixed generics as we do not see a point in selling generic version of Protonix to a
customer since it is unlikely to be launched in the US market anytime soon," said a pharma analyst.
Shanghvi also expressed concern over reduction in price negotiating ability in the US market. "Around 80
% business will be consolidated among 3-4 customers. It will reduce our negotiating capabilities."
DCGI SUSPENDS RANBAXY'S SUPPLY
The Asian Age, 31 May, 2014
In a major development, the Drugs Controller General of India (DCGI) has suspended supplies from one of
Ranbaxy's manufacturing units to the European Union (EU). The DCGI inspects domestic manufacturing
facilities supplying to the European Union (EU), on behalf of its regulator. Based on the inspection of
Ranbaxy's Toansa plant in Punjab, the DCGI recently.suspended Ranbaxy from exporting pharmaceutical
products to European countries. "Due to the suspension of written confirmation to EU from Toansa plant,
ranbaxy cannot export to EU till they comply with the set standards," said a senior official in the health
ministry. Earlier, the the US FDA had put restriction on manufacturing and distributing pharmaceutical
ingredients after flaws were found at their drug manufacturing unit, after which the Indian drug regulators
woke up to review the ranbaxy plant. The Drug DCGI had asked for lifting samples of ranbaxy drugs for
independent testing.. While most of the samples have been found be found to be fit in its other facilities
which are under scrutiny. , "Non compliance was found in the Toansa plant after which its license of export
to EU was terminated," added the official.
EMA FINDS RANBAXY'S MANUFACTURING SITE IN TOANSA NO RISK TO PUBLIC
HEALTH
Pharmabiz, 6 June, 2014
European regulatory authorities have finalised their assessment of reported non-compliance with Good
Manufacturing Practice (GMP) at Ranbaxy Laboratories’ manufacturing site in Toansa, India that had led to
the suspension of the GMP certificate for the site in the European Union (EU). Although the assessment
showed that there were a number of GMP deficiencies at the concerned site, assessment of all available
information has reassured European regulators that there has been no risk to public health from these
deficiencies. Patients should continue to take their medicines as prescribed by their healthcare professional.
European regulators also considered the corrective measures put in place by the company and were satisfied
that the measures are sufficient to ensure GMP-compliant manufacture of products at the site. As a
consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014.
The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates. The
assessment followed an inspection by the US Food and Drug Administration (US FDA) which revealed
areas of non-compliance with GMP at the site. The European medicines regulatory network responded
quickly to the FDA’s findings, and sent a team of inspectors from Germany, Ireland and the UK, who were
joined by inspectors from Switzerland and Australia to undertake an unannounced international inspection
of the site. The GMP inspection concluded that appropriate corrective and preventive measures have been
put in place by the manufacturer.
CHRYSCAPITAL TO SELL 10% IN DRUG MAKER INTAS PHARMACEUTICALS TO
TEMASEK FOR OVER $160 MILLION
Economic Times, 3 June, 2014
In what would be one of the most profitable recent exits in Indian private equity, ChrysCapital is selling its
stake in drug maker Intas Pharmaceuticals at nearly 20-fold returns. According to sources, Temasek has
emerged as frontrunner to pick up the stake valuing the Ahmedabad-based company at Rs 8,800 crore.
Others, such as Capital International and Goldman Sachs, were also in the fray for the deal finally clinched
by the Singapore sovereign wealth fund, which is expected to pick up over 10% stake in the company. The
deal size has been pegged at about $160-170 million, or Rs 950-100 crore. The transaction comes at a time
when PE industry is struggling with exits due to factors like a tepid IPO market and depreciating currency.
"It's a significant and great news for PE Industry, given emergence of secondary deals as a viable exit route
and the exit value," said Raja Lahiri, partner for transaction advisory services at Grant Thornton. The deal is
now awaiting clearance from Foreign Investment Promotion Board, the nodal body on clearing foreign
direct investments in India. Jayesh Shah, CFO at Intas Pharmaceuticals, confirmed talks with Temasek but
declined to comment on transaction details. "I cannot comment on valuation right now as the deal is not yet
signed. But we have filed with FIPB, and the process is going on," he said.
SUN MAY SHINE ON HEALTHY MARGIN, VALUATION MAKES CIPLA ATTRACTIVE
Economic Times, 3 June, 2014
Drugmakers Sun Pharmaand Cipla have reported contrasting performance in the quarter to March. Sun
Pharma's rich profitability with an operating margin of 44 %, was its high point during the three months
while its topline growth of 32 % compared with the year-ago period was a tad disappointing. The
company's US sales grew 22 % in dollar terms, but its non-US international sales remained flat. Its unit
Taro's sales grew 13 %, lagging the growth rate posted by its US business. The company maintained its
edge in the domestic business though, with revenues growing strongly at 21%, faster than the industry
average. In the current fiscal, the company has targeted to file 25 ANDAs (abbreviated new drug
applications) in the USandhasguided for a conservative revenue growth of 13-15% that does not include
Ranbaxy's consolidation. On the other hand, Cipla's profitability continued to be afflicted by low-margin
antiretro-viral business and high staff costs and over-heads for the second consecutive quarter. While the
consolidated revenues grew at 27 %, driven by growth in export sales, the operating profit dropped 4% and
operating margin contracted 5.3 percentage points to 16.8%. The sales from the domestic business,
contributing 40 % of the revenues, grew strongly at 19 %, higher than the industry growth. Cipla has
increased its market share from 4.7% to 5.3% in the domestic market. Its management has guided for a
growth of 15 % in revenues and operating margin of 21% for the current fiscal. The second half of the fiscal
is likely to be better than the first due to the proposed launch of combination inhalers in Europe.
BIOCON ARM, BRISTOL-MYERS SQUIBB EXTEND DRUG DISCOVERY PARTNER
Financial Express, 4 June, 2014
Syn-gene, the contract research arm of India's largest biotechnology firm Biocon, on Tuesday said its drug
discovery and development collaboration with US pharma company Bristol-Myers Squibb has been
extended by five years. The two firms had entered into a collaboration in 2007 with Syngene setting up the
Biocon Bristol-Myers Squibb Research Center (BBRC) that houses 500 scientists in Bangalore. The firms
did not reveal financial terms of the contract extension. So far, the collaboration has produced six drug
candidates for further study besides helping Bristol-Myers Squibb reduce the time and costs associated with
advancing new compounds to first-in-human studies, said a release from Biocon. "One drug candidate
currently in clinical trials was discovered at BBRC and early non-clinical development work done at BBRC
has enabled most of Bristol-Myers Squibb's small molecule assets to advance to later stages of development
over the last five years," it said. The Bangalore centre, currently Bristol-Myers Squibb's largest research and
development centre outside the US, is aimed at developing integrated capabilities in process chemistry,
biology, biotechnology, bio-markers, drug metabolism and pharmacokinetics, analytical research, and
pharmaceutical development. "We are delighted to extend our discovery and development partnership with
Bristol-Myers Squibb for another five years. This extension reflects the strength of our existing
collaboration which has delivered many successful outcomes," said Peter Bains, director, Syngene
International. "BBRC has supported the non-clinical development of a large proportion of our smallmolecule portfolio assets since its inception, and is a premier example of the high-quality innovative drug
hunting that is taking place in India today," said Francis Cuss, executive vice president and chief scientific
officer, Bristol-Myers Squibb.
ANOTHER US FIRM EYES INDIA BUY
Business Standard, 4 June, 2014
US-based drug maker Amneal Pharmaceuticals LLC, headed by Chintu Patel and Chirag Patel, may be the
latest among multinationals eyeing India for expanding its manufacturing footprint. The company, it is
learnt, is in advanced talks to buy Hyderabad-based oncology products manufacturer Epsilon
Pharmaceuticals. According to an industry source, the deal is also likely to include sale of a manufacturing
facility that received approvals of the US Food and Drug Administration (US FDA). The transaction could
be valued at Rs.80-100 crore, he said. A detailed questionnaire e-mailed to Amneal Pharmaceuticals did not
elicit any response. Phone calls made to Epsilon's Hyderabad office remained unanswered. According to
Epsilon's website, the company is mainly engaged in manufacturing sterile injectibles for treatment of
cancer. Incorporated in November 1998, Epsilon Pharmaceuticals has a facility spanning over 20,000
square metres in Jedcherla special economic zone near Hyderabad. Exclusive for multi-product sterile
dosage form manufacturing, the facility has a capacity to make up to 5 million lyophilised vials and up to
10 million liquid filled sterile vials, it said. For Amneal, the buyout may make sense as it already has
presence in the generic drug manufacturing space. Moreover, oncology injectibles is seen as a high-growth
segment, which also allows higher margins compared with conventional generic products. Global injectible
market is pegged at over §15 billion. Recently, Mylan, another American generic drug maker, acquired
Strides Arco-lab's injectible manufacturing subsidiary, Agila Specialities in a $1.8-billion deal. Others such
as Hospira have also expanded their presence in the injectible manufacturing space in India. However,
Amneal Pharma already had presence in India through its R&D (research and development) facility in
Bavla near Ahmedabad. Amneal develops over a dozen generic products from this centre annually across all
dosage forms, all of which are to be filed from its US facilities. Industry officials say if the two companies
seal the deal, they may also need clearance from the Foreign Investment and Promotion Board.
FDA FINDS FLAWS AT WOCKHARDT'S US PLANT
Mint, 4 June, 2014
Wockhardt Ltd, the gener-ics drug maker that has faced quality issues at two of its Indian plants, was cited
by the Food and Drug Administration (FDA) for testing lapses at a factory in Illinois. The FDA issued a
Form 483 listing possible violations of the Food Drug and Cosmetic Act after inspecting Wockhardt's drug
making facility in Morton Grove, Illinois, over seventeen days between January and March, according to a
document on the agency's website. Two of the Mumbai-based drug maker's local facilities are already
banned from exporting to the US after inspections where the FDA reported similar violations. If Wockhardt
fails to address the problems, the latest observations could hurt the company's supply to its biggest market.
The facility generated more than half of Wockhardt's US sales last quarter. Wockhardt's US business
dropped 26% in the year ended March 2014 following the import restriction on the two other factories. The
contribution from US sales dropped to 45% of total revenue from 51% the year before. The Form 483,
issued on 26 March and containing 12 observations, said the plant's quality unit doesn't have documented
procedures and some systems weren't followed. The Wockhardt factory in Illinois is the latest Indian facility
to come under FDA scrutiny. Four factories from India's Ranbaxy Laboratories Ltd are banned from selling
to the US and the FDA this year put import restrictions on a Sun Pharmaceutical Industries Ltd plant.
IPCA, ONCOBIOLOGICS IN PACT FOR BIOSIMILARS
Mint, 3 June, 2014
Mumbai-based drug maker Ipca Laboratories Ltd has said on Monday that it has entered into an alliance
with Oncobiologics Inc., a US-based biological drug researcher, for the development, manufacture and
commercialization of biosimilar monoclonal antibody products. The biologies covered under this alliance
are among the most popular therapies in the world for immunology and cancer indications, c.h.
unnikrishnan
STRONG US SHOWING AIDS AUROBINDO'S EARNINGS
Business Standard, 3 June, 2014
Expectations of a good performance and the Aurobindo Pharma stock's 28 per cent rise through the last
three months weren't unjustified, with the company posting better-than-expected results for the quarter
ended March. Largely led by its performance in the US, Aurobindo posted 48.4 per cent year-on-year
growth in consolidated revenue at Rs.2,330 crore; the company's net profit more-than-tripled to Rs.502
crore. Sale of US formulations rose 129 per cent, owing to strong sales of anti-depressant Cymbalta.
Increased sales of high-margin drugs such as Cymbalta helped Aurobindo post its highest ever earnings
before interest, tax, depreciation and amortisation margin of 31.9 per cent. What aided the company's
performance in the US market was gain in market share for key products. Bank of America Merrill Lynch
(BoAML) analysts estimate the company's market share in the US generics market increased from 1.6 per
cent in FY11 to four per cent in March 2014. The market share for Cymbalta, a drug with a market size of
§5 billion, launched about six months ago, is pegged at about 25 per cent. These gains have helped
Aurobindo more-than-triple its US revenue from §56 million in the first quarter of FY12 to $186 million in
the March quarter 2014. Analysts expect the company to sustain sales in the US due to its product pipeline
of injectables, antibiotics and controlled substances. BoAML analysts believe the pipeline will ensure 20
per cent annual revenue growth during FY14-16, in dollar terms.
PHARMA M & AS TO DRIVE INFOSYS' LIFE SCIENCES BIZ
Business Standard, 5 June, 2014
Infosys, India's second largest software services company, expects the recent spate of mergers and
acquisitions (M&As) in the global pharmaceutical sector to boost its life sciences business over the next 12
months. "There is a lot of M&A activity happening in the life sciences space. When M&A is typically
initiated, budgets are tightly controlled, because companies are hoarding cash to ward off (rival bids) and to
make the sale happen," said Manish Tandon, senior vice-president and global segment head of life sciences.
"As these M&As are fructified in the next six months to a year, a lot of new work will be generated. We are
confident we will get a lot of business there." In April, Swiss drug maker Novartis announced a multibillion dollar revamp. As part of it, the company swapped assets with GlaxoSmithKline and sold its animal
health arm to simplify business and increase focus on high-margin cancer medicines. In India, Sun
Pharmaceutical Industries bought Ranbaxy Laboratories in a $4-billion transaction, making the combined
entity the world's fifth-largest generic drug maker by sales. Pfizer tried to buy the UK's second largest
pharmaceutical company, AstraZeneca, but the deal did not come through. Life sciences makes for nearly
five per cent of Infosys' revenue and till recently, it was part of the company's retail and life sciences
business segment that comprised retail and consumer packaged goods, transport and logistics, life sciences
and health care. The combined segment grew 3.4 per cent in October-December 2013 over the previous
quarter but shrank 3.5 per cent in January-March
SUN PHARMA NOT TO ALLOW RANBAXY MINORITY INVESTORS A MERGER VETO
Mint, 5 June, 2014
Sun Pharmaceutical Industries Ltd will settle for nothing short of a full merger with Ranbaxy Laboratories
Ltd although some minority investors want to maintain Ranbaxy as a separate unit and nurse it back to
financial health before proceeding with the union. The drug maker, which on 6 April agreed to buy Ranbaxy
for $3.2 billion (around ^19,200 crore) in stock in addition to assuming $800 million of debt, will walk
away from the deal rather than keep Ranbaxy as a separate entity in case the merger, due to be completed by
end-2014, is nixed, said three people including a senior Sun Pharma executive. "The deal will cease to exist
if the merger doesn't happen," said the executive, who didn't want to be identified. The transaction, aimed at
creating India's largest drug maker and the world's fifth largest maker of generic, or off-patent drugs, has
come under scrutiny of the Securities and Exchange Board of India (Sebi) over allegations of insider trading
in Ranbaxy shares in the run-up to the announcement of the deal. "Any findings by Sebi that proves the
insider trading of Ranbaxy shares would directh' impact the merger," said a Mum-bai-based corporate
lawyer, who spoke on condition of anonymity- For Sun Pharma, a merger of Ranbaxy's operations with its
own is crucial. The acquisition will allow the company to expand in countries where it hasn't ventured so far
and give it access to Ranbaxy's product pipeline in the US and the large distribution network in India. It will
result in cost savings of $250 million for Sun Pharma. Maintaining Ranbaxy, which has been battling
regulatory issues with the US Food and Drug Administration (USFDA), as a separate entity would mean
large overlaps of business and overheads. "Given that the deal is beneficial for all shareholders of Sun as
well as Ranbaxy, we expect the deal to be approved," a Sun Pharma spokesperson wrote in response to Mint
queries. Japan's Daiichi Sankyo Co. Ltd agreed to sell its stake in Ranbaxy to Sun Pharma at f 457 per
share; it had bought the stake five years ago paying 61% more. Ranbaxy and Daiichi declined to comment
for this story. The transaction requires approvals from the audit committee, shareholders including minority
investors and the boards of directors. The transaction will need approval by a majority, representing 75% in
value of the shares present and voting at the shareholder meetings of Sun Pharma and Ranbaxy. The deal hit
a roadblock within days of it being signed after two minority shareholders challenged the merger in the
Andhra Pradesh high court, alleging insider trading in Ranbaxy shares. The shareholders cited a sharp rise
in the share price of Ranbaxy prior to the announcement of the acquisition. The high court first ordered an
interim stay on the merger, asking Sebi to withhold approval for the union, but later vacated the stay and
asked the market regulator to investigate the allegations. Experts say the merger process could face other
obstacles. The Companies Act, 2013 and listing norms of Sebi under the related-partv transaction clause
also makes a special resolution by minority shareholders mandatory for approving mergers and acquisition
deals between two companies. In the Sun-Ranbaxy case, according to experts, there are two grounds which
could probably be invoked to prove a relationship between the parties involved. First is the equity that
Silverstreet Developers Lip, a wholly owned subsidiary of Sun Pharma, holds in Ranbaxy.
GLENMARK OPENS NEW UNIT IN SWITZERLAND FOR CLINICAL MATERIAL
Politicel Business Daily, 5 June, 2014
GLENMARK Pharmaceuticals today opened a n-ew manufacturing facility in Switzerland for supply of
clinical trial material. Glenmark Pharmaceuticals SA (GPSA), a wholly-owned subsidiary of the company
has opened its new GMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds,
Switzerland, Glenmark Pharma said in a statement. "This manufacturing facility supplements Glenmark's
existing in-house discovery and development capabilities and will supply material for clinical
development," it added. Glenmark Pharma Biologies-president Michael Buschle said: "We have been doing
cutting edge work in the area of novel monoclonal antibodies and have several monoclonal antibody
candidates & bispecific antibodies in the pipeline. The manufacturing facility would help us bring these
antibodies to the clinic faster..." An antibody is a protein produced by plasma cells that is used by the body's
immune system to identify and neutralise foreign particles .such as bacteria and viruses. The focus for the
biologics R&D centre is to develop novel biologic entities for the treatment of pain, oncologic,
inflammatory and respiratory conditions, Glenmark Pharma said. Since its inception around 10 years back,
Glenmark's biologies research centre has filed several patents on novel biologic entities, it added.
INTERNATIONAL
ADAPTIMMUNE INKS CANCER IMMUNOTHERAPY PACT WITH GSK TO DEVELOP &
COMMERCIALISE NOVEL CELL-BASED THERAPIES
Pharmabiz, 3 June, 2014
Adaptimmune Limited, a leading biotechnology company developing TCR engineered T-cells to treat
cancer, has entered into a strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for
the development and commercialisation of its lead clinical cancer programme. Using its unique T-cell
receptor (TCR) engineering technology, Adaptimmune has created TCRs which are deployed to target the
cancer testis antigen, NY-ESO-1, and other targets. The company’s trials in the NY-ESO-1 programme in
multiple myeloma, melanoma, sarcoma and ovarian cancer in the US are generating encouraging results,
with European trials set to commence shortly, and it has a pipeline of follow-on programmes. Under the
terms of the agreement, Adaptimmune will co-develop its NY-ESO-1 clinical programme and associated
manufacturing optimisation work together with GSK. GSK will have an option on the NY-ESOprogramme through clinical proof of concept, anticipated during 2016, and, on exercise, will assume full
responsibility for the programme. The companies will also co-develop other TCR target programmes and
collaborate on further optimization of engineered TCR products. According to the agreed development plan,
the deal could yield payments in excess of $350 million to Adaptimmune over the next seven years, with
significant additional development and commercialisation payments becoming due in subsequent years if
GSK exercises all its options and milestones continue to be met.
GSK IN $350MDEAL TO DEVELOP CANCER DRUGS
Financial Chronicle, 3 June, 2014
GlaxoSmithKline has agreed a deal worth more than $350 million with British biotech company
Adaptimmune to develop cancer drugs, based on novel cell-based therapies. Adaptimmune said on Monday
it would collaborate with GSK on its lead clinical program, which it said had already generated encouraging
results in multiple myeloma, melanoma, sarcoma and ovarian cancer in trials in the United States. The
privately-owned company said it could receive payments in excess of $350 million over the next seven
years from the tie-up, subject to development goals being met, and significant development and
commercialisation payments in subsequent years. Adaptimmune said it would also receive sales royalties,
ranging from single to double digits on net sales, on any products that reach market. The company's cancer
therapies work by re-engineering the patient's own t-cells, a type of white blood cell, to target and destroy
cancerous or infected cells. GSK manufactures drugs and vaccines for major disease areas such as asthma,
cancer, infections, diabetes, digestive and mental health conditions, the biggest selling of which were
Advair, Avodart, Flovent, Augmentin, Lo-vaza, and Lamictalin 2013. Many medicines were historically
discovered or developed at GSK and its legacy companies and are now sold as generics. Its drugs and
vaccines earned 21.3 million in 2013. Its consumer healthcare division, which earned 5.2 million in 2013,
sells oral healthcare and nutritional products, drinks and over-the-counter medicines, including Sensodyne,
Boost and Horlicks.
US FDA GRANTS FAST TRACK STATUS TO ASTRAZENECA’S NOVEL ANTIBIOTIC
CANDIDATE AZD0914
Pharmabiz, 5 June, 2014
The US Food and Drug Administration (US FDA) has granted fast track status to AstraZeneca's novel
investigational drug AZD0914 as a Qualified Infectious Disease Product (QIDP) for the treatment of
uncomplicated gonorrhoea, which is increasingly resistant to existing antibiotics and poses a serious global
public health threat. AZD0914 is a novel oral antibiotic entering phase II clinical trials to investigate
efficacy in treating uncomplicated gonorrhoea and is the first of a novel class of molecules to be developed
for this indication. Uncomplicated gonorrhoea is becoming increasingly difficult to treat as the Neisseria
gonorrhoeae bacterium has developed resistance to successive classes of antibiotics. There are currently few
treatment options and the US Centers for Disease Control and Prevention has recently designated Neisseria
gonorrhoeae an immediate public health threat that requires urgent and aggressive action. The QIDP
designation was created by the US Generating Antibiotic Incentives Now (GAIN) Act, implemented in
2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious
or life-threatening infections. Fast Track status is a process designed to facilitate and speed-up interactions
with the FDA on issues related to study design, safety data, the use of biomarkers and other critical issues in
the development and regulatory review of drugs. The QIDP and Fast Track designations mean that
AZD0914 is eligible for priority review by the FDA and a five-year extension of exclusivity under the US
Hatch-Waxman Act if approved. If untreated, gonorrhoea can lead to serious and permanent health
problems including pelvic inflammatory disease, first-trimester abortions, ectopic pregnancy and infertility.
The World Health Organisation estimates that in 2012, gonoccocal infections represented 106 million of the
estimated 498 million new cases of curable sexually transmitted infections that occur globally every year.
BAYER, ORION ENTER AGREEMENT TO DEVELOP & COMMERCIALISE NEW PROSTATE
CANCER TREATMENT
Pharmabiz, 3 June, 2014
Bayer has entered into a global agreement with Orion Corporation, a pharmaceutical company based in
Espoo, for the development and commercialisation of the compound ODM-201, an investigational novel
oral androgen receptor inhibitor. ODM-201 is in clinical development for the treatment of patients with
prostate cancer. Bayer and Orion plan to start jointly the clinical phase III programme to further evaluate the
efficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2014. These patients are at high risk of developing metastatic disease and can be identified due to
rapid Prostate Specific Antigen (PSA) increases. “We see in ODM-201 a potential new treatment for
patients with high risk non-metastatic castration-resistant prostate cancer and are looking forward to
developing this promising compound,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive
Committee and Head of Global Development. “Bayer’s oncology portfolio currently includes Xofigo which
has been shown to prolong life in patients with castrate resistant prostate cancer with symptomatic bone
metastases, and no known visceral metastases. From a clinical perspective, ODM-201 has the potential to
complement our portfolio in prostate cancer and enables us to deliver new treatment options for patients
who desperately need them.” "Joining forces with Bayer, I believe that we have again achieved a
collaboration that represents the best of all worlds," said Dr. Reijo Salonen, SVP R&D and chief medical
officer for Orion. “Bayer has recently committed to developing therapies in Oncology, particularly for
prostate cancer. At Orion, we continue our track record of inventing innovative molecules. And most
importantly, for patients with prostate cancer, this partnership will bring a medicine that will make an
important difference to their lives." Under the terms of the agreement, Bayer and Orion will jointly develop
ODM-201, with Bayer contributing a major share of the costs of future development.
PROVENCE TECHNOLOGIES GROUP BUYS SYNPROSIS
Pharmabiz, 4 June, 2014
Provence Technologies Group, a specialist fine chemistry research group, has acquired Synprosis, a
company specialized in the chemical synthesis of peptides and proteins for therapeutic use. Synprosis is
based in Aix-en-Provence, France. The financial terms of the agreement were not disclosed. The deal opens
up new development opportunities for the Provence Technologies Group in the area of biologically active
pharmaceuticals. Synprosis has a ten-year history of producing active principles in the field of vaccines
under development (for malaria, cancer, and allergies, etc.), as well as in other therapeutic fields (for
neurogenerative diseases and the treatment of pain). The company was first recognised for its expertise in
creating synthetic vaccines for HIV and malaria. The technology developed by Synprosis offers
significantly increased peptide production yields with a cost reduction of 30 to 40 per cent. The Group’s
new entity has adopted the name Provepep. Synprosis will be the division specialized in pharmaceuticalstandard production, in keeping with good manufacturing practices. Jean-Pierre Salles, who founded
Synprosis, will remain in the Provepep executive management team.
PFIZER WALKS AWAY FROM $118 BN ASTRAZENECA BID
Western Times, 2 June, 2014
Pfizer abandoned its attempt to buy AstraZeneca for nearly 70 billion pounds as a deadline approached
without a last minute change of heart by the British drugmaker. The decision ends a month long public fight
between two of the world's biggest Pharmaceuticals companies that sparked political concerns on both and
corporate tax maneuvers.Following the AstraZeneca board's rejection of the proposal, Pfizer announces that
it does not intend to make an offer for AstraZeneca, Pfizer said in a short news release.
TEVA TO BUY BIOTECHNOLOGY COMPANY, LABRYS BIOLOGICS FOR $825 MILLION
Pharmabiz, 5 June, 2014
Teva Pharmaceutical Industries Ltd., and Labrys Biologics, Inc., a privately-held development stage
biotechnology company focused on treatments for chronic migraine and episodic migraine, announced that
Teva has entered into a definitive agreement to acquire Labrys, broadening Teva’s array of biotechnology
assets and capabilities. Teva will acquire Labrys for $200 million in upfront payment in cash at closing as
well as up to $625 million in contingent payments upon achievement of certain pre-launch milestones.
Potential peak sales for LBR-101 are estimated to reach $2 to $3 billion. With the goal of becoming a global
leader in pain by 2020, the Labrys acquisition adds a significant migraine prophylaxis dimension to Teva’s
extensive pain care franchise, which includes a range of investigational, approved and marketed treatments
for migraine, cancer pain and chronic pain. Labrys is developing LBR-101, a fully humanized monoclonal
antibody that binds to calcitonin gene-related peptide (CGRP) currently in phase IIb clinical trials for
prevention of chronic and episodic migraine. Teva’s acquisition of the LBR-101 programme targeting high
frequency episodic and chronic migraine clearly complements the recent addition of Zecuity, an innovative
therapy for the acute treatment of migraine, obtained through the acquisition of NuPathe. This ability to
treat both acute and chronic migraine builds on Teva’s broader pain portfolio, which was recently further
strengthened by positive pivotal phase III results achieved by Teva’s potential abuse-deterrent extended
release hydrocodone. The results gave a clear indication, in a clinical setting, of the promise of Teva’s
proprietary technology with potential abuse-deterrent properties in a range of opioid medications.
CRB, KEY ORGANICS SIGN EXCLUSIVE GLOBAL SUPPLY & MARKETING AGREEMENT
FOR PEPTIDES
Pharmabiz, 5 June, 2014
Cambridge Research Biochemicals (CRB), a leading independent producer of custom-made peptide and
antibody tools, and Key Organics Limited (Key Organics), a Tennant Group of Companies and a leading
supplier of R&D compounds and chemistry contract research services to the international life sciences
industries, have entered into a worldwide exclusive supply & marketing agreement that makes CRB’s
peptides available to Key Organics’ global life science customer base through its online BIONET catalogue.
Emily Humphrys, commercial director at CRB commented: “Our partnership with Key Organics will allow
us to expand the reach of our growing peptide product portfolio to a global market. We will continue to
focus on our core peptide activities, serving our key customers with bespoke custom-made peptides, whilst
Key Organics sells our new catalogue peptide range.” Joe Carey, managing director at Key Organics added:
“We have been seeking to extend our product range in the peptide area so are delighted to enter into this
agreement with CRB. The Company has established itself as a world leader in peptide chemistry with an
excellent quality and service record that conforms to the standards we have established for our BIONET
portfolio." Since CRB was established in 1980, the company quickly became a global leader in the supply
of custom–made peptides and has recently expanded its premises in Billingham, UK. CRB continues to
develop the range of products and services offered and can supply all flavours of peptides. This
encompasses simple to heavily modified targets and various labels can be incorporated, including stableisotopes, radio-isotopes and fluorescent dyes. Milligram to gram-scale quantities are offered, at the highest
levels of purity. Within its BIONET brand, Key Organics offers an extensive range of over 74,000 screening
compounds, intermediates, building blocks and biochemicals to the international pharmaceutical,
biotechnology and agrochemical industries. With new premises near Boston, USA, Key Organics is able to
supply its BIONET products to the North American market.
ARGEN-X INKS ALLIANCE WITH SHIRE PHARMA IN THERAPEUTIC ANTIBODIES
Pharmabiz, 5 June, 2014
arGEN-X, a clinical-stage biopharmaceutical company focussed on creating and developing differentiated
therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, has entered into a longterm strategic alliance with Shire Pharmaceuticals. Under the agreement, arGEN-X will bring its entire suite
of human antibody discovery technologies to a partnership focussed on multiple targets aligned with Shire's
therapeutic focus. The multi-year initiative aimed at helping augment the Shire development pipeline
follows an initial research and development collaboration undertaken in March 2012. "Our partnering
philosophy at arGEN-X is to create alliances for the long term with select, top tier companies. We have
certainly upheld this principle by repeatedly expanding our collaboration with Shire, with today's
announcement marking our most ambitious and exciting venture with them to date," said Tim Van
Hauwermeiren, chief executive officer, of arGEN-X. "We have enjoyed consistent success in our
collaboration, recognising important synergies in combining our strengths and capabilities.
ENDO COMPLETES SALE OF BRANDED PHARMACEUTICAL DRUG DISCOVERY
PLATFORM TO ASANABIOSCIENCES
Pharmabiz, 3 June, 2014
Endo International announced that its Endo Pharmaceuticals subsidiary has completed the sale of its
branded pharmaceutical drug discovery platform to AsanaBioSciences, LLC, an independent member of the
Amneal Alliance of Companies. The deal includes an upfront payment as well as milestones on the
achievement of certain development objectives. Endo initiated the exploration of strategic alternatives for
the portfolio of early stage drug discovery assets in 2013 as part of the company's portfolio optimisation
process. The sale includes multiple early-stage drug discovery and development candidates in a variety of
therapeutic areas, including oncology, pain and inflammation, among others. "The sale of the early stage
discovery platform is another step in the transformation of Endo," said Rajiv De Silva, president and chief
executive officer, of Endo. "We continue to make progress against the strategic objectives we set forth in
2013 and remain enthusiastic about what lies ahead for Endo. We are committed to supporting the organic
growth of our existing business segments as we search for attractive acquisition targets to enhance our
portfolio of pharmaceutical products." Endo International plc is a global specialty healthcare company
focused on improving patients' lives while creating shareholder value. Endo develops, manufactures,
markets, and distributes quality branded pharmaceutical, generic and device products through its operating
companies.
MERCK SERONO INTRODUCES UPDATED ELECTRONIC INJECTION REBISMART FOR
SELF-ADMINISTRATION OF REBIF
Pharmabiz, 4 June, 2014
Merck Serono, the biopharmaceutical division of Merck, has introduced its updated electronic injection
RebiSmart for self-administration of Rebif (interferon beta-1a). Rebif is the disease-modifying treatment of
the company, which is used as basic therapy for the treatment of relapsing-remitting form of multiple
sclerosis (MS). The new RebiSmart allows patients to inject Rebif themselves, and may also collect
information about injection times, dates and doses administered and store and wirelessly send the safe
MSdialog server. But only the new RebiSmart must be inserted into a corresponding transmitter and then a
button to be pressed. Together with the new RebiSmart, Merck Serono also conducts a the new, web-based
software system MSdialog. This allows people with MS to become actively involved in the management of
their disease by being regularly called upon to fill abstracts of health-related questionnaires that are based
on established procedures and standardized scales - such as the MSQLI (Multiple Sclerosis Quality of Life
Inventory) - and the MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire. In addition,
doctors and MS nurses can monitor patient compliance as well as the course of their health on the basis of
regular questionnaires. "To encourage patients through knowledge and technologies and to enable, may
have the potential to improve patient outcomes, as it allows the patient, even to contribute to document their
disease," said Dr. Gavin Giovannoni, Professor of Neurology at the Barts and The London School of
Medicine and Dentistry. "This new RebiSmart and MSdialog platform can provide physicians access to
certain therapy data of their patients in real time, so that the time can be used during the doctor visit to
discuss important patient-specific topics and issues. Moreover, these technologies enable the patient to more
indepth knowledge of their own disease. " Patients who use MSdialog, have the choice between E-mail and
SMS reminders for the self-application of their medication.
DCC VITAL ACQUIRES WILLIAMS MEDICAL HOLDINGS
Pharmabiz, 4 June, 2014
DCC plc, the international sales, marketing, distribution and business support services group, announces
that DCC Healthcare's subsidiary DCC Vital has acquired Williams Medical Holdings (Williams), the
market leader in the supply of medical and pharmaceutical products and related services to general
practitioners in Britain. The consideration was paid in cash at completion, based on an enterprise value of
£45 million. Williams supplies a wide range of own and third party branded products medical equipment,
consumables and pharmaceuticals to a very broad customer base of c.10,000 GP practices, as well as
healthcare providers in the community care and domiciliary care sectors. The business also provides a range
of services including field based testing & calibration and repair & maintenance of equipment. The
Williams business model, similar to that in DCC Technology, is based on telesales, e-commerce, product
catalogues and key account management, supported by high quality IT systems and cost effective logistics.
Williams has 165 employees and operates from a modern, purpose built facility in Rhymney, SouthWales.
In its last financial year ended 31 July 2013, Williams recorded an adjusted operating profit of £6.0 million.
DCC Vital is building a substantial business focussed on sales and distribution of own and third party
pharmaceuticals and medical devices across all channels to the healthcare market.
US FDA ACCEPTS GENZYME'S LEMTRADA RESUBMISSION FOR REVIEW
Pharmabiz, 31 May, 2014
The US Food and Drug Administration (FDA) has accepted for review the Genzyme's resubmission of
supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the
treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the
Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter. This resubmission is
based on data from the same clinical studies included in the original sBLA, and provides supplemental
analyses and additional information to specifically address issues previously noted by the FDA in its
December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month
following constructive discussions with the agency. Genzyme has pioneered the development and delivery
of transformative therapies for patients affected by rare and debilitating diseases for over 30 years.
QIAGEN COLLABORATES WITH LILLY TO CO-DEVELOP COMPANION DIAGNOSTICS
FOR SIMULTANEOUS ANALYSIS OF DNA & RNA BIOMARKERS IN COMMON CANCERS
Pharmabiz, 31 May, 2014
Qiagen N.V., a Netherlands-based leading global provider of sample & assay technologies, has entered into
a collaboration with Eli Lilly and Company to co-develop universal and modular assay panels for the
simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in
common cancer types. The agreement includes the development of tests that will be based on Qiagen’s
multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and
biomarkers in a single test. “We are excited to add a new stage to our successful collaboration with Lilly,
this time co-developing a broad panel of molecular assays covering a range of biomarkers with diverse
nucleic acid analytes and modalities to guide the use of tailored therapies. We believe our technology can
enhance Lilly’s development of innovative therapies for the benefit of cancer patients,” said Peer M Schatz,
chief executive officer of Qiagen. “In addition to a broad portfolio of PCR-based assays targeting more than
25 biomarkers, Qiagen’s personalized healthcare offering has expanded to include universal solutions using
next-generation sequencing (NGS) and now also a unique and proprietary multi-modal, multi-analyte
testing technology. Our collaborations with Lilly are among more than 20 co-development and cocommercialization projects underway with leading pharmaceutical and biotechnology companies.” Richard
B Gaynor, senior vice president, oncology-clinical product development and medical affairs, of Lilly, said:
“Certain applications in biomarker development for tailoring oncology therapeutics require the combined
analysis of DNA and RNA, and this collaboration provides a multi-modal, multi-analyte solution that can
process multiple sample types and biomarkers in a single test. We are pleased to work with Qiagen on this
novel platform to support our development programmes.” The new collaboration is the fourth project in the
two companies’ long-standing partnership.
MISSION PHARMACAL STARTS PROMOTION OF ELESTRIN IN US MARKET
Pharmabiz, 31 May, 2014
Mission Pharmacal Company, a privately held pharmaceutical company based in San Antonio, has begun
exclusive promotion of Elestrin (estradiol gel) 0.06 per cent in the United States through an agreement with
Meda AB. Elestrin is a prescription medicine approved by the Food and Drug Administration (FDA) for use
as a topical hormone replacement gel to treat moderate-to-severe hot flashes due to menopause. Using
estrogen-alone may increase your chance of getting cancer of the uterus (womb). The addition of Elestrin
complements and expands Mission Pharmacal's existing line of branded products for women. Established in
1946 in San Antonio, Texas, the company has a long history of service and expansion in the women's health
sector. Mission Pharmacal therapies for women include a premier line of prescription prenatal vitamins, an
innovative bone health product, anti-infectives, an iron supplement, a urinary analgesic, and now Elestrin.
"Mission Pharmacal's commitment to women's health has never been stronger," says Dan Kibbe, senior vice
president, Pharmaceutical Division, Mission Pharmacal. "The addition of Elestrin further enhances our
position as one of the most valuable partners in providing healthcare solutions for obstetricians and
gynaecologists (OB/GYNs) and their patients in the women's healthcare community." Elestrin also directly
supports Mission's vision to offer innovative, science-based products that meet the nutritional and
healthcare needs of people at every life stage.
CELL THERAPEUTICS RENAMES AS CTI BIOPHARMA CORP
Pharmabiz, 31 May, 2014
Cell Therapeutics, Inc. (CTI or the Company), a biopharmaceutical company focussed on acquiring,
developing and bringing to market novel targeted therapies for blood-related cancers, announced that it will
change its corporate name to CTI BioPharma Corp. effective May 30, 2014. The company's common stock
will continue to trade under its current ticker symbol: "CTIC." "The rebranding from Cell Therapeutics to
CTI BioPharma comes at a defining moment in our company's history and better reflects who we are today
and our aspirations for becoming a leader in developing therapies for patients with blood-related cancers,"
said James A Bianco, managing director, president and chief executive officer of CTI BioPharma. "From the
beginning, CTI has looked at potential therapies from the patient's perspective to address both the clinical
need and the impact treatment can have on a patient's life. This inspires everything we do and is evident in
the drug candidates we are currently pursuing and those we'll look to acquire. Currently, we have a growing
commercial presence in Europe for Pixuvri (pixantrone) for patients with relapsed aggressive B-cell nonHodgkin lymphoma, and a promising late-stage pipeline that includes a phase 3 programme for pacritinib, a
novel JAK2/FLT3 inhibitor, for patients with myelofibrosis."
ROCHE BUYS CALIFORNIA-BASED DNA SEQUENCING FIRM, GENIA TECHNOLOGIES
FOR US$ 350 MN
Pharmabiz, 2 June, 2014
Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics,
announced the acquisition of Genia Technologies, Inc. (Genia), a privately held company, based in
Mountain View, California, USA. Genia is developing a single-molecule, semiconductor based, DNA
sequencing platform using nanopore technology. Under the terms of the agreement, Roche will pay Genia’s
shareholders USD 125 million in cash. In addition to this payment from Roche, Genia’s shareholders may
receive up to USD 225 million in contingent payments depending on the achievement of certain milestones.
Genia’s proprietary technology is expected to reduce the price of sequencing while increasing speed and
sensitivity. “The acquisition of Genia is a further step for Roche to introduce a potentially disruptive
technology to the market,” said Roland Diggelmann, COO of Roche Diagnostics. “The addition of Genia’s
single molecule semiconductor DNA sequencing platform using nanopore technology strengthens our next
generation sequencing pipeline.” “We are very excited about continuing our successful development as part
of the Roche Group and bringing our technology to researchers on a global scale,” said Stefan Roever, CEO
of Genia. Once the transaction is complete, Genia will be integrated into Roche Sequencing Unit and will
continue to focus on the development of this innovative system.
NEWRON PHARMA SUBMITS SAFINAMIDE NDA TO US FDA
Pharmabiz, 2 June, 2014
Newron Pharmaceuticals S.p.A. (Newron), a research and development company, and its partner Zambon
S.p.A., an international pharmaceutical company, have announced that the New Drug Application (NDA)
for safinamide was submitted to the US Food and Drug Administration (FDA). The submission covers the
indications "safinamide as add-on therapy to a stable dose of a single dopamine agonist" in early
Parkinson's disease patients and "safinamide as add-on therapy to levodopa alone or in combination with
other Parkinson's disease treatments" in mid-to late stage Parkinson's disease patients. The submission was
based on completion of activities agreed upon during meetings with the FDA. The submission was made by
Newron, which is the NDA holder until completion of the sublicense process for the US rights to
safinamide, by Zambon. Stefan Weber, Newron's CEO, commented: "We are both proud and excited to be
submitting the company's first ever NDA, for safinamide. Parkinson's disease is a debilitating condition and
this brings us one crucial step closer to providing an innovative treatment to improve the quality of life for
these patients." Ravi Anand, Newron's CMO, commented: "Following the usual review periods, we are
optimistic that safinamide will receive approval within Europe by end of this year, and in the US within 12
months.
POLYPLUS-TRANSFECTION LAUNCHES LATEST OPTIMISED TRANSFECTION REAGENT
FECTOPRO
Pharmabiz, 31 May, 2014
Polyplus-transfection SA, a privately-held company specialising in the development of innovative solutions
for transfection, announces the launch of FectoPRO, the latest optimised transfection reagent in their
product portfolio. FectoPRO has been designed for high yields in medium and large-scale production of
proteins and antibodies in mammalian cells. Polyplus has designed FectoPRO to deliver very high protein
yields in CHO and HEK cell line systems, the current industry standard systems and most commonly used
by bio-production scientists. FectoPRO will also produce up to three times more protein using half the DNA
required by other leading commercial transfection reagents. In addition, scientists working with transient
gene expression (TGE) systems using FectoPRO will be able to benefit from reproducibility experiment-toexperiment and between reagent batches. “The bio-production markets, specifically those using larger scale
transient transfection systems, have continued to increase their need for higher protein yields whilst
decreasing costs and reducing the time to develop viable lead molecules. In our communication with
customers, across all sections of this market, these were the consistent and clear messages coming back to
us time and time again,” said Mark Bloomfield, cief executive officer, of Polyplus-transfection.
SANGAMO & CITY OF HOPE GET $5.6 MN GRANT FROM CIRM TO SUPPORT TRIAL OF
STEM-CELL BASED ZFP THERAPEUTIC FOR HIV/AIDS
Pharmabiz, 2 June, 2014
The California Institute for Regenerative Medicine (CIRM) has granted a $5.6 million Strategic Partnership
Award to Sangamo BioSciences, Inc. to fund clinical studies at City of Hope to develop a potentially
curative ZFP Therapeutic for HIV/AIDS based on the application of Sangamo's zinc finger nuclease (ZFN)
genome-editing technology in hematopoietic stem/progenitor cells (HSPCs). "Sangamo's powerful and
precise ZFN-mediated genome editing technology allows us to modify a patient's own stem cells and
perform 'autologous' transplants, with the potential to replicate the functional cure obtained for the 'Berlin
Patient' in any HIV-infected individual," said John A. Zaia, M.D., Professor & Chair, Department of
Virology, Beckman Research Institute of City of Hope and a member of the clinical team that will be
conducting the pilot clinical trial of this ZFP Therapeutic. "We are very pleased to be working with
Sangamo to test this important immunologic approach in the clinic." The four-year grant provides matching
funds to support evaluation of Sangamo's stem cell-based ZFP Therapeutic in HIV-infected individuals in a
clinical trial conducted at City of Hope. The grant application entitled, "A Phase 1, Open-Label Study to
Assess the Safety, Feasibility and Engraftment of Zinc Finger Nucleases (ZFN) CCR5-Modified
Autologous CD34+ Hematopoietic Stem/Progenitor Cells (SB-728mR-HSPC) with Escalating Doses of
Busulfan in HIV-1 (R5) Infected Subjects with Suboptimal CD4 Levels on cART" tied for the highest
scientific score and was one of two applications recommended for funding in this round of CIRM's
Strategic Partnership Awards. CCR5 encodes a critical co-receptor for HIV infection of immune cells. A
naturally occurring mutation of the CCR5 gene, CCR5 delta-32, results in the loss of expression of the
CCR5 protein on the surface of immune cells. Individuals who carry the CCR5 delta-32 mutation on both
copies of their CCR5 gene (CCR5 delta-32 homozygotes) are not susceptible to the most common strain of
HIV. One HIV-infected individual, known as the 'Berlin Patient,' underwent stem cell transplantation with
HSPCs from a CCR5 delta-32 homozygote achieving what is considered to be a "functional cure" of his
HIV and enabling him to remain off antiretroviral medication for more than six years. As stem cell
transplantation is limited by the availability of HLA-matched, homozygous CCR5 delta-32 donors,
Sangamo's approach is designed to make HIV-infected individuals their own donor using ZFN technology
to disrupt the CCR5 gene in their HSPCs.
WIRB-COPERNICUS FORMS NEW CANCER-FOCUSED INSTITUTIONAL REVIEW BOARD,
WCG ONCOLOGY
Pharmabiz, 2 June, 2014
The WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services
for clinical research, announced the formation of a new cancer-focused institutional review board, WCG
Oncology. The company also unveiled the members of its prestigious WCG Oncology Expert Advisory
Board. This Board will provide strategic counsel to WCG regarding the changing oncology research
landscape, covering cutting-edge theory, scientific methods, technologies, and study designs. WCG
Oncology Board members include James E. Rothman, Ph.D., chairman of cell biology at Yale Medical
School, and recipient of The Nobel Prize in Physiology or Medicine in 2013; John E. Niederhuber, M.D.,
CEO of Inova Translational Medicine Institute and former director of the National Cancer Institute; and
Arnold J. Levine, Ph.D., professor at the Institute for Advanced Study at the School of Natural Sciences,
and professor in the Departments of Pediatrics and Biochemistry at the Robert Wood Johnson Medical
Center. They are joined by Howard I. Scher, M.D., chief of the Genitourinary Oncology Service at the
Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan Kettering; John M. Falletta,
M.D., pediatric oncologist and IRB chair at Duke University Medical Center, and former vice chair of the
Copernicus Group IRB; and George D. Demetri, M.D., director of the Ludwig Center at Harvard and senior
vice president for Experimental Therapeutics at the Dana-Farber Cancer Institute. Donald A. Deieso, Ph.D.,
WCG’s Chairman and CEO, commented, “Advancing science has created exciting and very promising new
approaches to cancer treatment. To assure the proper risk-benefit assessment of these new approaches, the
IRB members must possess a deep understanding of the underlying science and clinical aspects of the
associated treatments. WCG Oncology will provide our clients with the confidence that reviews will be
conducted with therapeutic focus.” “Oncology is one of the fastest-evolving medical fields,” added WCG
Chief Clinical Research Officer Lindsay McNair, M.D., M.P.H., M.S.B.
NOVOZYMES INKS PACT TO CONDUCT RESEARCH ON NOVEL SUBUNIT VACCINE
COMPLEX BASED ON ALBUMIN FUSION TECHNOLOGY
Pharmabiz, 2 June, 2014
Novozymes Biopharma has entered a new collaborative research agreement with one of the world’s top
vaccine companies. The partnership will enable the company to evaluate Novozymes Biopharma's modified
recombinant human albumin (rAlbumin) Veltis technology, to assess the dosing and performance of a novel
subunit antigen vaccine candidate. “This collaborative research agreement with one of the leading vaccine
companies showcases the potential application of Novozymes’ proven albumin-based half-life extension
technology in the vaccine space”, says Svend Licht, Global Head of Sales & Business Development,
Novozymes Biopharma. He continues, “The Veltis technology could overcome many of the limitations of
current subunit vaccines, resulting in both improved healthcare and economic outcomes.” The human
immune system's capability to respond effectively to replicating viruses means that some live attenuated
vaccines are effective with a single dose. Subunit vaccines are regarded as a safer and more specific
alternative to live attenuated vaccines; however, they are often limited by the requirement for multiple
dosing and the need for adjuvants to improve the immune response. Novozymes Biopharma’s Albumin
vaccine complex technology, based on the genetic fusion or conjugation of a subunit antigen to Novozymes’
sequence modified albumin variants, has been specifically designed to overcome these limitations by
allowing the fused or conjugated antigenic species to remain in circulation for a longer period of time than
the uncomplexed antigen. Veltis’ long half-life is due to a receptor mediated recycling process in the cells
lining blood vessels. In specific immune cells, this receptor has been shown to facilitate presentation of
antigens when bound to antibodies as a complex. The Albumin vaccine complex technology should
similarly be presented in these immune cells, potentially eliciting a powerful and protective immune
response. The agreement covers a feasibility study between the parties and is not expected to have any
impact on Novozymes’ financial results in 2014. Recently Novozymes has also announced that its half-life
extension technology is being used by Janssen and GlaxoSmithKline.
THE BUTTERFLY TREE GETS LICENSE TO IMPORT PRODUCTS FOR MALARIA
PREVENTION & OTHER VECTOR-BORNE DISEASES
Pharmabiz, 5 June, 2014
The Butterfly Tree, a UK charity and NGO in Zambia to support rural communities decimated by the HIV
pandemic in Zambia, has been given a licence to import two safe new products to use in the prevention of
malaria and other vector-borne diseases. Globally malaria is the biggest killer of man. 75 per cent of people
who die from malaria are children under five, mostly in Sub-Saharan Africa. The products could potentially
save the lives of thousands of children and also help to prevent Onchocerciasis, commonly known as river
blindness, caused by the black fly. In areas of the Northern and Western Provinces one in ten people suffer
from this condition and currently there are no preventative methods available in Zambia. The Ministry of
Health and the Malaria Control Centre in Zambia have welcomed the products. They have been tested by
the London School of Hygiene and Tropical Medicine in the UK and the active ingredients used have been
approved by the World Health Organisation. The Butterfly Tree is to be given licenses to import and
distribute throughout Zambia. Besides using it for our humanitarian projects we are contacting all
corporates operating in the nation as this could be hugely beneficial to the mining, agriculture and tourist
industries. Many productive hours are lost as a result of malaria. By selling it to corporates we will be able
to create sustainability for our water, health, education and community projects in addition to extensively
distributing the products to vulnerable communities. The first product, MozziMort, is an insecticidal coating
used on any hard surface that lasts for two years and could replace the normal method of insecticide
spraying, which only lasts for six months. The second product, MozziMort Larvicide granules, prevents
mosquito larvae reaching adult stage.
DRUG FIRMS ACCUSED OF CREATING PAINKILLER ADDICTS
The Rakyat Post, 2 June, 2014
Chicago, the third-biggest US city, sued Johnson & Johnson and four other drug companies for allegedly
pushing consumer use of opioid painkillers, creating addicts and driving up its costs. More than 12 million
people abuse prescription painkillers annually, according to a study published March 3 in JAMA Internal
Medicine. Misuse of those drugs in 2008 killed more people than heroin and cocaine combined, according
to the U.S. Centers for Disease Control and Prevention. “Since 2007, the city has paid for nearly 400,000
claims for opioid prescription fills, costing nearly US$9.5 million (RM30.66 million) and suffered
additional damages for the costs of providing and using opiates long-term to treat chronic non-cancer pain,”
lawyers for the municipality alleged in a state court complaint filed in Chicago. Lawyers for the city of 2.7
million accused the drug companies of deceiving the public about the risks associated with the use of painkillers including Duragesic, made by Johnson & Johnson’s Janssen Pharmaceuticals unit, while overstating
their benefits. In May, two California counties made similar accusations in a lawsuit against the same
drugmakers. Johnson & Johnson, based in New Brunswick, New Jersey, is the world’s biggest health-care
products maker. Accusing the companies of civil conspiracy, fraud and violations of city laws, Chicago is
seeking unspecified money damages including coverage of the costs associated with its lawsuit. Other
drugmakers being sued by the city are Purdue Pharma Inc, maker of OxyContin, Endo Health Solutions Inc,
which makes Percoset and Percodan, Teva Pharmaceutical Industries Ltd and Actavis plc. The companies
and related entities engaged in a long-term campaign to alter public perceptions of the narcotics, which are
classified by the US as controlled substances, resulting in their increased use, increased instances of
addiction and users migrating to heroin because it is less expensive and sometimes easier to obtain,
according to the complaint. In the California case, Santa Clara and Orange counties sued the companies in
state court, claiming they marketed the drugs as rarely addictive, trivialised serious side effects and falsely
assured consumers that opioids were safer than over-the-counter drugs.
ROCHE ACQUIRES US GENE SEQUENCING FIRM GENTIA
Pharmatimes, 2 June, 2014
As part of its plans to expand in gene sequencing, Roche is acquiring Genia Technologies in a deal that
could be worth up to $350 million to the US firm. The Swiss major will pay privately-held Genia’s
shareholders $125 million in cash upfront and up to $225 million in contingent payments depending on the
achievement of certain milestones. The Mountain View, California-based company is developing a singlemolecule, semiconductor based, DNA sequencing platform using nanopore technology. Genia’s technology
“is expected to reduce the price of sequencing while increasing speed and sensitivity”, Roche noted. Roland
Diggelmann, chief operating officer of its diagnostics arm, said that getting hold of this technology
“strengthens our next-generation sequencing pipeline”. A couple of years ago, Roche finally walked away
from a proposed $6.60 billion bid to buy the gene sequencing market leader Illumina after the US firm
fought off an attempt to take control of its board.
TEVA READY TO SHELL OUT $825M ON LABRYS
Pharmatimes, 3 June, 2014
Teva Pharmaceutical Industries is snapping up private California-based biotech Labrys Biologics in a deal
worth up to $825 million. The Israeli drugmaker is particularly attracted to Labrys' experimental migraine
drug LBR-101 - a fully humanised monoclonal antibody that binds to the well-known target calcitonin
gene-related peptide (CGRP) - which is currently in Phase IIb clinical trials. According to the companies,
potential peak sakes for LBR-101 are an impressive $2 billion-$3 billion, and Teva says its addition
complements the recent acquisition of acute migraine drug Zecuity (obtained through its purchase of
NuPathe in January). "With its long half-life, target specificity and favourable pharmacokinetic profile
allowing for infrequent, and convenient, subcutaneous administration, LBR-101 represents a very exciting
biologic product candidate, and much needed option, for the management of this truly debilitating
condition," said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, further
explaining the interest. Under the terms of the deal, Teva will acquire Labrys for $200 million in upfront
payment in cash as well as up to $625 million in contingent payments upon achievement of certain prelaunch milestones.News of Teva's latest acquisition comes hot on the heels of an internal reshuffle via a
suite of organisational changes, including the appointment of Sigurdur Olafsson as President and CEO of a
newly established Global Generic Medicines Group, which will take on responsibility for all global
commercial activity from July 1.
APPLE PLAN TO REVOLUTIONISE MOBILE HEALTHCARE
Pharmatimes, 3 June, 2014
Apple has unveiled HealthKit, a platform to centralise data from different types of devices, like fitness
trackers, heart rate and blood pressure monitors. Launching iOS 8 for iPhones and iPads, which it describes
as the biggest release since the launch of the App Store, Apple gave much prominence to HealthKit, which
“gathers the information you choose from your various health apps and fitness devices, and provides you
with a clear and current overview in one place”. The new operating system offers developers the ability for
these apps “to communicate with each other”, the company said, and with permission of the user, each app
can use specific information from other apps “to provide a more comprehensive way to manage your health
and fitness”. Apple gave the example of the Nike+ apps using NikeFuel which “will be able to pull in other
key HealthKit metrics such as sleep and nutrition to build a custom user profile”. It has also teamed up with
Mayo Clinic in a move which will see the world-famous medical group launch a new app in September
offering its patients and consumers easy-access personalised health information, guidance and care when
they need it. Mayo chief executive John Noseworthy said that “we believe Apple’s HealthKit will
revolutionize how the health industry interacts with people”. Apple is also collaborating with the electronic
health records major Epic Systems so that HealthKit can be used by healthcare professionals to monitor
specific patient data. Craig Federighi, Apple’s head of software engineering, said the scheme is giving
developers “amazing new tools” to make managing health from devices “an integrated, simple and secure
experience”.
WELLNESS
HUL EXPANDS DISTRIBUTION NETWORK BY 50% IN TWO YEARS
Livemint, 2 June, 2014
Mumbai: Hindustan Unilever Ltd (HUL), India’s largest consumer packaged goods company, undertook its
most aggressive expansion drive by increasing its distribution network by 50% over the last two years. The
company also relaunched nearly two-third of its products portfolio, it said in its annual report for the year
2013-14 released on Monday. The company had said in its 2011-2012 annual report that it had reached 2
million stores across urban and rural India. Hindustan Unilever also increased the number of perfect stores
from 80,000 in 2010 to one million in 2013, the company said. A perfect store ensures that the right
products are available on the shelves and are marketed clearly. “Pilot studies in India and Argentina show
that outlets enrolled for the ‘perfect stores’ programme grow on average 4% more than other outlets,” said a
2012 Hindustan Unilever annual report. The Indian subsidiary of Unilever also added more than 17,000
Shakti entrepreneurs in 2013, taking the total count to 65,000. Shakti entrepreneurs are a network of rural
women reaching out and selling the company’s goods in villages where it has limited reach. Hindustan
Unilever has also developed a low-cost distribution model based on the mobile phone. “The company has
increased penetration in the interiors substantially,” said Arvind Singhal, chairman of Technopak Advisors
Pvt Ltd. According to the latest census, India has 7-8 million small stores selling consumer packaged goods
across 600,000 villages and 5,500 towns. Hindustan Unilever also relaunched 60% of its portfolio in one
year—making it one of the highest number of relaunches taking place in a single year.
INDUSTRY AND ECONOMY
PHARMA DEPT TO BAT FOR REVIVAL OF BULK DRUG INDUSTRY
Economic Times, 31 May, 2014
The Department of Pharmaceuticals in a presentation, it is preparing to brief Prime Minister Narendra
Modi, may pitch for the revival of the domestic bulk drug industry, which has lost much of its sheen over
the past decade. Citing instances of depending too much for drug raw materials from China, which has built
an immense competitive edge in API (Active Pharma Ingredients, main raw materials) and intermediates,
the pharma department could bat for measures to boost the domestic bulk drug sector, government officials
told ET. "In our presentation, we would focus on steps to reboot the bulk drug industry and overall
measures to improve the compe-tiveness of the pharma sector," an official told ET. India's API imports have
grown at a C AGR of 18 % in the last decade from a base of $801 million in 2004 to $3.4 billion in 2013,
ac-cordingto EXIM (Export-Import) database. An estimate of Indian Pharma Alliance, a grouping of
leading domestic drugmakers, reckoned earlier this year that for the API of many common drugs, India is
close to 90% dependent on China for imports. The top Indian drugmakers cite the case of APIs needed to
manufacture Vitamin C, antibiotics—Metronidazole, Ofloxacin, Livoflox-acin—to buttress their argument
on high dependence on Chinese imports of bulk drugs. The dependence is much higher in intermediates,
raw material other than APIs used in finished drugs. This exposes the pharma sector to price volatility and
supply side shocks like the one during Beijing Olympics of 2008, when China decided to shut down many
of its API plants due to pollution they were causing, which led to sharp spike in prices of many bulk drugs
at that time.
DESPITE EFFORTS, NEW MOLECULES ELUDE INDIAN PHARMA
Financial Express, 2 June, 2014
INDIAN pharma firms have tried for more than a decade now to develop new molecules but they've had
little luck so far. Over the last 15 years or so, several of them, including Glen-mark, Biocon Cadila
Healthcare, Dr Reddy's Laboratories, have put in the time and resources to try and discover some
blockbuster drug or other but their efforts haven't paid off. At least four of Glenmark's experimental drugs
were returned or abandoned by partners, according HSBC analysts. Apart from Crofelemer—a treatment for
HI V-related diarrhoea and in-licensed from San Francisco-based Napo Pharmaceuticals — none of its
pipeline drugs has fructified into marketable products. Oglemilast, a drug meant to target asthma and
chronic obstructive pulmonary disorder (COPD), for which Glenmark partnered with Teij in Pharma for
marketing rights in Japan and Forest Laboratories for US rights, was abandoned after the drug failed to
meet the main goals of a mid-stage study in 2009. Similarly, other out-licensed molecules such as
melogliptin, an anti-diabetic licensed to Merck, and GRC6211, a potential painkiller with Eli Lilly as the
licensing partner, were also junked after statistically insignificant results. Others too have met with little
success. Dr Reddy's Laboratories scrapped its promising anti-diabetic experimental drug, Balagli-tazone,
around 2011 after the drug failed to yield the requisite results. It had an out-licensing agreement with
Swedish drug-maker Novo Nordisk. Earlier in 2002, Ranbaxy had licensed out a prostate research molecule
to Schwarz Pharma. Yet, the deal hit a roadblock in November 2004, after the German company terminated
clinical trials due to unclear pre-clinical findings. Sujay Shetty ED and leader -pharma life sciences,
Pricewater-house Coopers, notes that NCE-styled research can be very difficult and takes years to be
perfected. "So there is no shame with some molecules being junked," he says. Nevertheles, out-licensing
products guarantees milestone-based payments, a revenue model which yields returns even if the product
does not materialise in the end.
GENERIC PHARMA COS SET EYES ON NEW GROWTH PILL
Economic Times, 4 June, 2014
Indian generic drug producers are devising fresh strategies to continue benefiting from the world's largest
pharmaceutical market, the United States, because exclusive marketing rights for off-patent drugs are not so
exclusive anymore. The US Food and Drug Administration (USFDA) has been clearing applications to
make generic drugs that are going off patent at a faster pace, which is resulting in increased competition.
Moreover, the FDA has been granting joint 'first to file' (FTF) status for several gener-ics, diluting the value
of the exclusive marketing right that comes with such a status. FTF refers to drugs whose generic, or lowcost, versions, can be launched by a drug-maker who enjoys a 180-day exclusive marketing period during
which no other generic versions can be sold. FTFs are the main growth drivers for most leading Indian
companies that make generic versions of expensive drugs that have gone off patent. Industry experts and
analysts point out that many domestic pharmaceutical companies that once enjoyed windfall gains
frequently through 180-day market exclusivity are realising that they cannot remain the sole players to reap
benefits of market exclusivi-. ty after the FDA amended guidelines to allow joint firsts to copycat
drugmakers. Out of India's $15 billion global pharmaceutical exports, domestic drugmakers depend on the
US market for at least $4 billion in sales. Abhijit Mukherjee, COO of India's second-largest drugmaker Dr
Reddy's Laboratories said the era of windfall gains from FTF is over.
CPHI WORLDWIDE ANNOUNCES FINDINGS OF PHARMA INSIGHTS REPORT ON TURKEY
Pharmabiz, 2 June, 2014
CPhI Worldwide, part of UBM Live’s Pharmaceutical Portfolio, has announced the findings of its Pharma
Insights report on Turkey ahead of an in-depth study to be published free of charge at CPhI Istanbul (June
4-6). The comprehensive analysis of the Turkish pharma market was conducted amongst all major Turkish
manufacturers, evaluating conditions for both foreign and domestic companies, and was compiled with the
help of research partner Global Business Reports. Overall the report concludes that pricing challenges
domestically have had a parallel effect of increasing the dynamism in the market and improving overall
competitiveness of the sector. As a result, the country now boasts a highly price efficient manufacturing
industry far cheaper than those in the West, coupled with a comparable regulatory standards, providing an
ideal mix of factors to establish Turkey as the key regional pharma economy. If reimbursement conditions
improve, this should provide the right environment for a burgeoning healthcare industry, with Turkey
having seen GDP per capita triple in the last 10-years alone. However, beyond the domestic reimbursement
market, niche products and export led growth is also providing a significant avenue for greater revenues.
Investment in new facilities is now taking place across the market, which CPhI concludes will see Turkey
establish itself as the definitive player and supplier of drugs across the MENA and CIS regions, with
exports even as far reaching as the Baltic states. Ultimately, the country’s manufacturers are now aiming to
begin supplying directly into Europe and even the US..
IPA-KARNATAKA BRANCH DELIBERATES
CHALLENGES IN PHARMA MANUFACTURING
Pharmabiz, 2 June, 2014
ON
SOLUTIONS
TO
REGULATORY
The Indian Pharmaceutical Association (IPA), Karnataka branch has highlighted regulatory roadblocks
faced by pharmaceutical manufacturers in terms of compliance. The recent global regulatory charges
against a few Indian companies have further pressed the need to relook at the manufacturing processes and
devise mechanisms to put in place systems. In order to place impending issues in perspective, IPAKarnataka branch organised a seminar on ‘Current Regulatory challenges in pharmaceutical manufacturing’
which is the first in the series after its parent body Indian Pharmaceutical Association commemorates its
Platinum Jubilee in December 2013. The half day event with 175 participants was held in Bengaluru at the
Atria Hotel on May 31,2014 which set the tone to highlight the issues and paved a roadmap for the future.
The event was inaugurated by Karnataka Health and Family Welfare principal secretary, Sivasailam N who
recommended scheduled inspections of pharma production facilities by the state drug control department
inspectorate team for which total support would be extended. In his opening remarks, Dr. BR Jagashetty,
president, IPA Karnataka branch and the former drugs controller, government of Karnataka pointed out that
the state pharma industry was known for its high standards of quality as was known for its total compliant
Schedule M certified companies after Gujarat and Maharashtra, besides being second in electronic
issuances of licenses after Gujarat. The state was the first to announce Karnataka pharmaceutical a policy
focusing on industry development among others. Further, the meets ensured industry, trade and academia an
opportunity to review and interact with experts. It provided a comprehensive overview and insights into the
regulatory challenges faced by Indian companies including those from Karnataka in the global
pharmaceutical market.
OVERWHELMING RESPONSE FOR PHARMA PRO&PACK 2014
Pharmabiz, 2 June, 2014
second edition of IPMMA initiative, PHARMA Pro&Pack Expo 2014 received a good response from
exhibitors and visitors with a huge flow of pharma professionals. PHARMA Pro&Pack Expo 2014 was
supported by more than 14 national and international associations. There were more than 480 pharma
manufacturing companies from 18 countries and more than 20,000 potential buyers including more than
1400 buyers from 140 countries at the PHARMA Pro&Pack Expo 2014 and iPHEX 2014. Member of
Parliament, Gopal Shetty, Dr G N Singh, Drug Controller General of India, Sudhanshu Pandey, Joint
Secretary, Dr P V Appaji, director general, Raghuveer Kini, executive director, Ashutosh Gupta, chairman,
Madan Mohan and vice chairman – Pharmexcil, Bhavin Mehta, chairman – iPHEX 2014, and Nipun Jain
were present at the inaugural of the twin events. The Indian pharmaceutical industry has been witnessing
phenomenal growth in recent years, driven by rising consumption levels in the country and strong demand
from export markets thanks to the large pool of talented young and experienced pharma professionals. In
the earlier days, Indian pharmaceutical industry was not so advanced as there were only a few pharmacy
colleges and emphasis was not given to the technological research and developments in the field of
pharmacy. But now the scenario has completely changed. Along with the development of pharmaceutical
companies, pharmaceutical machinery manufacturers are also advancing to meet the challenges of
pharmaceutical industries. Most of the leaders in the field are looking towards advanced markets like the
US and Europe for their pharma products.
IIHMR IN TALKS WITH THE AFGHANISTAN GOVT TO RE-BUILD HEALTH SERVICES IN
THE REGION
Pharmabiz, 2 June, 2014
The Indian Institute of Health Management Research (IIHMR) is in dialogue with the government of
Afghanistan to bid for another round of the project after the success of the Afghanistan Mortality Survey.
The institute is keen to monitor and evaluate the health system and chip in its expertise to rebuild the health
services and improving health status of the people in the country. The institute has signed an MoU with the
Afghanistan Center for Training and Development to strengthen research, training and consultancy services
in health management areas in Afghanistan. The Afghanistan Morality Survey conducted by IIHMR is a
unique model of large scale nationwide survey that provides the latest and the most authentic health
information about Afghanistan. IIHMR has also conducted program evaluations of TB Prevention and
control, HIV/AIDS, Leprosy, Malaria, and Blindness and has made significant contributions in strategies,
reorganisation of programme implementation mechanism design and monitoring systems. IIHMR has made
significant contributions in health systems research, capacity building and creating a critical mass of
professionally trained managers for health systems, stated Dr. SD Gupta, president, IIHMR University.
According to ML Mehta, chairman of IIHMR University “we have been designated as a WHO
Collaborating Centre for district health system based on primary health care. It has created a wide network
of research and academic institutes interested in public health research and management”. The Global
Alliance for Improved Nutrition (GAIN), Geneva has selected IIHMR as the only Project Management Unit
in the State of Rajasthan to implement the Food Fortification Project. Under the project IIHMR has signed
MoUs with various dairy companies, edible oil brands and wheat flour brands which have extensively
benefited more than 8.5 million individuals on a monthly basis through milk fortification and more than
80,000 individuals through wheat flour fortification. To generate awareness on Food Fortification and its
benefits, IIHMR has conducted sensitisation program for over 250 doctors. Further, the Union government
has also identified us as a collaborating institute for conducting 10 weeks Professional Development Course
(PDC) in Management, Public Health and Health Sector Reforms for District Medical Officers and more
than 235 doctors of Rajasthan have been trained under this course. Recently, with support from WHO, the
Ministry of Health and Family Welfare, Government of India nominated 92 officials to undergo one-month
training on “Public Private Partnership in Health” at IIHMR Jaipur. Apart from this, we have conducted
management research for improving maternal and child health programmes, adolescent health programmes,
reproductive health programmes and other National Health Programmes, said Professor Sodani, Dean,
IIHMR University.
FINANCIALS
SHASUN PROFIT DIPS 21%
The Hindu Business Line, 31 May, 2014
Chennai-based Shasun Pharmaceuticals has reported a 21 per cent drop in net profit at Rs 10.4 crore during
the quarter ended March 31. The company's top-line grew 31.4 per cent to Rs.363.2 crore against Rs 276.3
crore during the corresponding quarter last fiscal. During the fourth quarter, finance costs more than
doubled to Rs 13.7 crore from Rs 5.2 crore. The company had allotted 35 lakh shares and 71 lakh
convertible warrants to SeQuent Scientific Ltd, with which it has begun a joint venture to manufacture and
export veterinary products to the US. Posting an annual revenue of Rs 1,212.6 crore, the company also
missed its annual revenue growth forecast of a 30 per cent jump to Rs 1,410 crore during fiscal 2013-14.
Last fiscal, its revenue stood at Rs 1,084.7 crore. The company's share ended marginally lower at Rs 139 on
the BSE on Friday.
WOCKHARDT NET PLUNGES 77% FN Q4 ON IMPORT BANS
Western Times, 2 June, 2014
Drugmaker Wockhardt reported a 77 per cent drop in its net profit to Rs 74.45 crore during the quarter
ended March 2014, on the back of import alerts received from the international regulators. The company
reported a net profit of Rs 334.76 crore during the corresponding period of the previous year. Total income
form operations during the period under review declined to Rs 1038.67 crore form Rs 1485.50 crore, a drop
of 30%. Net profit for the year 2013-14, decreased by forty seven per cent to rs 840.71 crore form Rs
1594.12 crore during the previous year. The company received import bans from both USFDA and the
United Klingdom Medicines and Healthcare products Regulatory Agency on the Aurangabad and Daman
facilities. In may last year, the company's Waluj facility at Aurangabad received import ban over non
compliance to good manufacturing practices. Its Chikaithana facilities at Aurangabad and Kadaiya facility
at Daman also came under regulatory scanner. According to a pharma analysts with a Mumbai based
brokering company, the drop in net profit was expected. Three of its units are under ban and which are
selling to the US and UK markets. The few products which have bene given a respective by the foreign
regulators comprises a very small amount/There is a double whammy for the company. While the overall
sales i the US market is affected, thee is remedial costs which is adding to its woe. The company during the
quarter, increased its research spend significantly which stood at 9.7% of total slash at Rs 101 crore.
Including capital expenditure total. R&D spend accounted for 10.7% of sales during the quarter Wockhardt
field ten new product applications with the United States food and Drug Administration USFDA during the
quarter taking cumulative filings pending approval to 62. The company also field for 134 patens during the
quarter taking the cumulative filings to-2001 and has bene granted seventeen patens during the quarter
taking the cumulative patents granted to 259The company's international business contributed seventy nine
per cent of the total revenues during 2013-14.Wockhardt's US business declined by 26 percent durr ing the
fiscal and contrib-uted forty five per cent of' the global revenues.
PATENTS
'INDIAN PATENT LAW MATCHES GLOBAL STANDARDS'
Indian Express, 4 June, 2014
AFTER three major US companies — Boeing, Abbott and Honeywell — auto major Maruti Suzuki has
now come in support of India's intellectual property rights (IPR) regime, saying the 'Very strong" domestic
laws are on par with international standards. American pharma sector had alleged that Indian IPR laws
discriminate against US companies and violate global norms. "Maruti Suzuki India firmly believes that the
patent law in India is very strong; especially the changes that happened after the TRIPS agreement have
made Indian Patent law at par with the international standards," the company said in its views submitted to
the commerce and industry ministry. MSI said: "Many recent judgments have proved that strong patent law
not only secures the rights of patentee, but also ensures genuine public need. The IPR law in India provides
transparent system of securing and enforcing the patent rights." It also said that the Indian government
grants patents to encourage inventions. "We have not observed any violation of our IP rights and our rights
are fully secured under Indian IP laws," it added. The company, however, said that "further betterment in the
processes would always help stakeholders and the awareness to enforcement agencies for proper execution
of laws". MSI has one of the biggest automobile R&D set-ups in India, where it develops technologies and
files IPR for them.
VENUS REMEDIES GRANTED PATENT
Mint, 4 June, 2014
Venus Medicine Research Center, the discovery research arm of drug maker Venus Remedies Ltd, has been
granted a product patent by the European Union Patent Office (EPO) for a novel antibiotic product, code
named VRP008, to treat drug-resistant bacterial infection. VRP008 is a combination of anti-bacterial drug
carbapenem and a novel amino glycoside-a new chemical entity. It is the outcome of eight years of research
by Venus, which has been focusing on anti-microbial resistance.
MYLAN SETTLES GENERIC CELEBREX PATENT LITIGATION WITH PFIZER
Pharmabiz, 3 June, 2014
Mylan Inc., a global pharmaceutical company, has entered into a settlement and license agreement with
Pfizer Inc. relating to Mylan's Abbreviated New Drug Application (ANDA) filed with the US Food and
Drug Administration (FDA) for Celecoxib capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is
the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis,
rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Under the
terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any
case not later than December 2014. All other terms and conditions of the settlement and license agreement
are confidential, and the agreement itself is subject to review by the US Department of Justice and the
Federal Trade Commission. Additionally, Mylan has appealed the decision by the United States District
Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against
the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility
for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the
aforementioned settlement. For the 12 months ending March 31, 2014, Celebrex had US sales of
approximately $2.34 billion, according to IMS Health.
VENUS REMEDIES GETS EUROPEAN PATENT FOR ANTIBIOTIC DRUG
Economic Times, 3 June, 2014
Drug major Venus Remedies today said its research arm Venus Medicine Research Centre has received
patent for its antibiotic product 'VRP008' from European Patent Office (EPO). The product is designed for
mixed multi-drug infections for pediatric, geriatric and adult immuno-compromised patients where the risk
of adverse events is high and very low amount of doses are required, Panchkula-based company said in a
statement issued here today. "Once launched, VRP008 (research code for this Antibiotic Adjuvant Entity)
will be one of the best solutions for ICU infections," said Manu Chaudhary, Joint Managing Director cum
Director Research, Venus Remedies Limited. This product, which consists of a carbapenem and a novel
amino glycoside, is the outcome of the eight years of research and it is developed by following stringent
international guidelines defined for developing a new drug and has undergone for pre-clinical studies such
as Acute Toxicity, Sub Acute toxicity, Intravenous, para venous toxicities as per OECD guidelines, the
statement said. At present, at least 25,000 people die each year in the European Union from infections due
to 'Eskape' pathogens which are multi-drug-resistant organisms. Infections caused by these antibioticresistant bacteria resulted in approximately 2.5 million extra hospital days annually in Europe. Venus has
already received EU patent for its product Elores, Potentox, Vancoplus and Achnil.
COURT ALLOWS TEVA MOVE AGAINST NATCO
Mint, 31 May, 2014
The Delhi high court on Friday set aside a decision by a single judge of the same court dismissing a civil
suit by Israeli drug maker Teva Pharmaceutical Industries Ltd for an injunction against Natco Pharma Ltd
on grounds of lack of jurisdiction. Allowing an appeal to Teva, the two-judge bench of chief justice G.
Rohini and Rajiv Sahai Endlaw declared that the high courts jurisdiction could extend to those cases where
there was an apprehension of marketing products manufactured through a patented process in the territory
of Delhi. Shreeja Seh
ACTAVIS SIGNS AGREEMENT WITH CEPHALON TO SETTLE NUVIGIL PATENT
LITIGATION
Pharmabiz, 3 June, 2014
Actavis has entered into an agreement with Cephalon, Inc. to settle all outstanding patent litigation related
to Actavis' generic version of Nuvigil (armodafinil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg).
Nuvigil is a prescription medicine indicated to improve wakefulness in adult patients with excessive
sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD) or narcolepsy. Under
the terms of the agreement, Cephalon will grant Actavis a license to market generic versions of 100 mg and
200 mg Nuvigil beginning on June 1, 2016, or earlier under certain circumstances. Cephalon will also grant
Actavis a license to market generic versions of 50 mg, 150 mg and 250 mg Nuvigil beginning 180 days
after the initial launch of generic versions of those dosage strengths. Other details of the settlement were not
disclosed. Based on available information, Actavis believes it is a "first applicant" to file an ANDA for the
generic versions of 100 mg and 200 mg Nuvigil and expects to be entitled to 180 days of generic market
exclusivity. For the 12 months ending February 28, 2014, Nuvigil had total US sales of approximately $437
million, according to IMS Health data.
VENUS REMEDIES GETS EUROPEAN PATENT FOR THE DRUG VRP008 TO FIGHT MULTIDRUG RESISTANT BACTERIA
Pharmabiz, 3 June, 2014
Venus Remedies Limited has received another patent grant for a novel antibiotic product VRP008
consisting of a carbapenem and a novel amino glycoside (NCE entity) from EPO. This product is the
outcome of the eight years of research put in by Venus Medicine Research Centre, pioneering into
antimicrobial resistance research. “We have been working dedicatedly to provide effective and affordable
solution to the compounding problem of anti-microbial resistance ever since we recognized this problem
more than 10 years ago. . We have received from all over the globe for our novel antibiotic entities such as
Elores, Potentox, Vancoplus and VRP008 (the research code for this AAE). Once launched, VRP008 will be
one of the best solutions for ICU infections,” informed Dr Manu Chaudhary, joint managing director cum
director Research, Venus Remedies Limited. The product is designed for mixed multi-drug infections for
pediatric, geriatric and adult immuno-compromised patients where the risk of adverse events is high and
very low amount of doses are required. It is expected to capture a wide range of market sector which is
upheaval with antibiotics for wide indications. Presently, at least 25,000 people die each year in the
European Union from infections due to ESKAPE pathogens which are multi-drug-resistant organisms. The
economic impact is estimated at € 1.5 billion per year. Infections caused by these antibiotic-resistant
bacteria resulted in approximately 2.5 million extra hospital days annually in Europe. Product is developed
by following the stringent international guidelines defined for developing a new drug and has undergone for
pre-clinical studies such as acute toxicity, sub acute toxicity, intravenous, para venous toxicities as per
OECD guidelines, efficacy and safety studies established through a series of microbiological studies carried
out as per CLSI guidelines. Apart from these, stringent stability studies on all four zone conditions
including reconstitution stability have been carried out. In 2009, the global anti-infectives market generated
revenues of $79.12 bn for 12 months to second-quarter, 2009. Over this period, the systemic antibacterial
market accounted for 46.9 per cent of this market segment reaching $37.14 bn in revenues. The total
worldwide revenues for the systemic antibacterials drugs for 12 months to the Q2 were $37.14 bn. Overall
growth for the forecast period from 2009 to 2024 is estimated to be 6.76 per cent (CAGR) rising to a figure
of $99.13 bn.
POLICY AND REGULATIONS
NPPA SEEKS STATES' PARTICIPATION TO KEEP DRUG PRICES UNDER CONTROL
Economic Times, 4 June, 2014
The drug pricing regulator has urged state governments to identify expensive and most commonly used
drugs for diseases prevalent in their regions, which they think should be brought under price control in
public interest. This comes close on the heels of National Pharma Pricing Authority's (NPPA) plans to lower
prices of expensive medicines used for select therapeutic categories such as cancer, HIV, diabetes,
cardiovascular diseases, malaria and tuberculosis, as reported by ET last month. The NPPA has also sought
feedback from state drug controllers and state health secretaries on its plans to cut prices of these therapies.
"There are some diseases which are concentrated in a few regions; for instance, Japanese encephalitis in UP,
Bihar and the North-Eastern states. Considering India's size and diversity, some drugs which may be very
important in one part of the country may not be so relevant in another part and, therefore, it becomes
essential for states to participate in this process," said an NPPA official. However, this issue could prove to
be a flashpoint between the drug pricing regulator and pharma industry, which believes that NPPA is going
beyond its brief of regulating prices of 652 drugs enlisted in the National List of Essential Medicines
(NLEM) of 2011. The regulator, on the other hand, says that the new law allows NPPA to fix and revise
price caps of drugs in public interest and this clause applies to both drugs which are part of the NLEM and
those outside of it. Last month, in an internal meeting, NPPA approved a proposal to monitor prices of all
drug brands in these therapeutic categories and fix prices of those which are being marketed or launched at
significantly higher prices. To begin with, the plan involves tracking retail prices of single ingredient drug
brands.
GOVERNMENT TO DISTRIBUTE FREE MEDICINES THROUGH PUBLIC HOSPITALS
Economic Times, 31 May, 2014
The government will soon start work on distributing free medicines through public hospitals across the
country, health minister Harsh Vardhan said on Friday, reviving a plan that former prime minister
Manmohan Singh had promised in his Independence Day speech in 2012 but did not implement due to
apparent lack of resources. Vardhan plans to revive the central council of health (CCH), a body that
comprises health ministers of all states in the country as well as experts, to take the discussion forward on
firming up the model to implement the programme. The minister decided this in a meeting he had held with
senior health ministry officials on the previous day. "I am sure my colleague health ministers in the states
are keen to ensure the success of this programme," Vardhan said, adding despite the Union Cabinet's formal
clearance in May 2013, the implementation of the programme remained restricted to a few hospitals in big
cities because the infrastructure for procurement and distribution was not put in place. Health economists
have lauded the new government's move to prioritise the programme. "The plan has been in the making for
the last three years. If implemented effectively, it will significantly reduce out-ofpocket expenditure in the
country. The Tamil Nadu and Rajasthan model should be replicated in the other states," said public health
expert Sakthivel Selvaraj. According to Planning Commission's estimate, a countrywide free generic drug
programme will cost Rs 28,560 crore during the 12th Five-Year Plan period.
INJETI SRINIVAS APPOINTED AS NPPA CHAIRMAN
Economic Times, 3 June, 2014
Government has appointed Injeti Srinivas as the new Chairman of National Pharmaceuticals Pricing
Authority (NPPA). The Appointments Committee of the Cabinet has approved the appointment of Injeti
Srinivas as NPPA Chairman, the Ministry of Personnel, Public Grievances and Pensions said in a statement.
Srinivas will replace the current Chairman CP Singh. NPPA fixes, revises the prices of controlled bulk
drugs and formulations in the country. It also enforces prices and availability of the medicines in the
country. Besides, it recovers amounts overcharged from consumers by manufacturers for the controlled
drugs.
PRODUCT APPROVALS
US FDA APPROVES TRIMEL PHARMA'S NATESTO NASAL GEL TO TO TREAT MEN WITH
LOW TESTOSTERONE
Pharmabiz, 2 June, 2014
The United States Food and Drug Administration (US FDA) has approved Trimel Pharmaceuticals
Corporation's Natesto (testosterone), formerly CompleoTRT, the first and only testosterone nasal gel for
replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous
testosterone. Natesto is self-administered via a nasal applicator thereby minimising the risk of secondary
exposure to testosterone of women or children. “In my practice I regularly encounter men demonstrating
symptoms of hypogonadism and physicians will increasingly see this as the North American population
ages,” said Dr. Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida
(CRSA). “For these patients seeking to restore their testosterone levels, Natesto will offer an alternative
delivery system that is safer and more convenient than the other options currently available on the market.”
It is conservatively estimated that nearly 13 million American men may have low testosterone levels.
Current treatment guidelines focus on the restoration of the physiological testosterone level through the use
of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous
pellets, transdermal patches, intramuscular injections, oral tablets, as well as a buccal patch.
AUROBINDO GETS USFDA NOD FOR BIPOLAR DISORDER DRUG
The Hindu Business Line, 4 June, 2014
Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to
manufacture and market Divalproex sodium extended-release tablets. The product is ready for launch. The
drug is the generic equivalent of AbbVie Inc's Depakote ER extended-release tablets and indicated for the
treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic
features. The product has a market size of approximately $ 690 million for the twelve months ending March
2014 according to IMS. "This ANDA has been approved out of Unit VII (SEZ) formulation facility in
Hyderabad," the company said in a release issued here. Aurobindo now has a total of 194 ANDA approvals
(168 final approvals, including 7 from Au-rolife Pharma LLC and 26 tentative approvals) from USFDA
STRIDES ARCOLAB RECEIVES US FDA APPROVAL FOR METHOXSALEN CAPSULES
Pharmabiz, 6 June, 2014
Strides Arcolab has received the approval from the United States Food & Drug Administration (US FDA)
for Methoxsalen capsules USP, 10 mg (soft gelatin capsules). According to IMS data, the US market for
generic Methoxsalen capsule is approximately USD 13.6 million, with no generic player. The product will
be manufactured at the company’s US FDA approved oral dosage facility at Bengaluru and marketed
directly by Strides in the US market. Methoxsalen is a drug used to treat psoriasis, eczema, vitiligo and
some cutaneous lymphomas in conjunction with exposing the skin to UVA light from lamps or sunlight.
Methoxsalen modifies the way skin cells receive the UVA radiation, clearing up the disease. Strides Arcolab
develops and manufactures a wide range of IP-led niche pharmaceutical products. The company has five
manufacturing facilities presence in more than 75 countries in developed and emerging markets.
CLINICAL TRIALS
GSK'S PHASE III STUDY OF ANTI-HER2 AGENTS LAPATINIB & TRASTUZUMAB FAILS TO
MEET PRIMARY ENDPOINT
Pharmabiz, 3 June, 2014
GlaxoSmithKline plc (GSK) announced that the phase III study of two anti-HER2 agents, lapatinib
(Tykerb/Tyverb) and trastuzumab, did not meet the primary endpoint of improved disease free survival
(DFS) compared to single agent therapy with trastuzumab as adjuvant treatment for HER2 positive early
breast cancer. The safety profile was consistent with the established safety profile of the study drugs, with
no new safety signals observed. These results were presented at the 50th Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago, Illinois. “While it is disappointing that ALTTO did not
meet its primary endpoint, we now have a tremendous amount of information that will help to further our
knowledge of the biology of this disease and inform future studies in HER2 positive breast cancer in the
adjuvant setting. Further analysis of these data will continue over the coming months,” said Dr. Rafael
Amado, senior vice president Oncology R&D at GSK. “We are most grateful to the more than 8,000
patients across the world who participated in ALTTO—their generous contribution to the scientific
community will facilitate a greater understanding of this aggressive disease.” The primary analysis of the
study tested for superiority (p=0.025) between the combination arm and trastuzumab alone with respect to
DFS; the trastuzumab followed by lapatinib arm was tested for non-inferiority (p=0.025). The results
showed that at four years, 88 per cent of women lived without their disease returning (4-year DFS) in the
lapatinib plus trastuzumab arm and 86 per cent in the trastuzumab arm . The 4-year DFS rate for the
trastuzumab followed by lapatinib arm was 87 per cent compared to 86 per cent in the trastuzumab arm
Adverse events (AEs) more frequently reported in the lapatinib plus trastuzumab arm compared to the
trastuzumab arm were diarrhoea (75per cent vs. 20 per cent ), rash (55 per cent vs. 20 per cent ) and
hepatobiliary (23 per cent vs. 16 per cent). Diarrhoea, grade 3 or higher, was increased in all lapatinib
containing treatment arms (5-15 per cent ), compared to trastuzumab alone (1per cent ).
LILLY'S CYRAMZA IMPROVES OVERALL SURVIVAL IN PHASE III NSCLC STUDY
Pharmabiz, 3 June, 2014
Eli Lilly and Company announced detailed results from REVEL, a global phase III study of Cyramza
(ramucirumab) in combination with chemotherapy in patients with second-line non-small cell lung cancer
(NSCLC). Data from the trial were published in The Lancet and also presented at the American Society of
Clinical Oncology (ASCO) Annual Meeting. REVEL is the first positive Phase III study of a biologic in
combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone
in second-line NSCLC. Lung cancer is the leading cause of cancer death in the US and most other
countries, and non-small cell lung cancer accounts for 85 per cent of all lung cancer cases. It is estimated
that approximately half of NSCLC patients are receiving treatment in the second-line setting. Despite
currently available therapies, there continues to be a need for new second-line treatment options for patients
with NSCLC. "While there have been other recent Phase III studies that have evaluated the addition of a
cytotoxic or targeted agent in previously-treated NSCLC patient populations, none have demonstrated
improved overall survival in the total patient population," said Richard Gaynor, managing director, senior
vice president, product development and medical affairs for Lilly Oncology. "We are pleased that Cyramza
demonstrated a significant survival improvement in a difficult-to-treat patient population where there
continues to be a major unmet medical need in both nonsquamous and squamous NSCLC patients. These
data build on Lilly's continued commitment to discovering potential new treatment options for the large
numbers of people fighting lung cancer. They also add to our growing clinical data set for Cyramza, which
is being studied in multiple tumour types." The global, randomised, double-blind REVEL trial compared
Cyramza plus docetaxel to placebo plus docetaxel in NSCLC patients with progression after platinum-based
chemotherapy for locally-advanced or metastatic disease. The international study included a total of 1,253
nonsquamous and squamous NSCLC patients from 26 countries on six continents
NOVARTIS' PHASE II TRIAL OF INVESTIGATIONAL COMPOUND LDE225 SHOW MARKED
TUMOR RESPONSES IN ADVANCED BASAL CELL CARCINOMA
Pharmabiz, 3 June, 2014
Novartis announced the results of a pivotal phase II trial demonstrating that patients with locally advanced
(laBCC) or metastatic basal cell carcinoma (mBCC) taking the investigational oral compound LDE225
(sonidegib) had marked and sustained tumour shrinkage after a median follow-up of 13.9 months. The data
were revealed for the first time today in an oral presentation at the 50th Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago "These results represent an important milestone in the
clinical development of LDE225, as well as in our research strategy to develop new therapies for patients
with unmet needs," said Alessandro Riva, managing director, Global Head, Novartis Oncology
Development and Medical Affairs. "These data will form the basis for the filing of another important new
medicine for a skin-related disease in which Novartis is building a leading position." The trial assessed the
efficacy and safety of two oral doses of LDE225, 200 mg and 800 mg, in patients with laBCC or mBCC.
The primary endpoint was the objective response rate (ORR), defined as the proportion of patients with
complete or partial tumor response, or shrinkage, as measured by a central review committee. The study
met the primary endpoint in both treatment arms with ORRs of 41.8 per cent (95 per cent) confidence
interval in the 200 mg arm and 32.5 per cent (95 per cent CI: 25.1, 40.5) in the 800 mg arm. More
specifically, 47.0 per cent of patients with laBCC and 15.4 per cent of patients with mBCC, in the 200 mg
arm, and 35.2 per cent of patients with laBCC and 17.4 per cent of patients with mBCC in the 800 mg arm,
achieved an objective response.
PHASE 3 STUDY OF VELCADE-BASED THERAPY SIGNIFICANTLY IMPROVES
PROGRESSION-FREE SURVIVAL COMPARED TO STANDARD THERAPY AS FRONTLINE
TREATMENT OF PATIENTS WITH MCL
Pharmabiz, 3 June, 2014
Millennium: The Takeda Oncology Company announced results from the primary analysis of an
international, randomized phase 3 study that showed treatment with a Velcade (bortezomib)-based
combination therapy demonstrated a 59 per cent relative improvement in the study’s primary endpoint of
progression-free survival (24.7 vs. 14.4 months; Hazard Ratio among previously untreated patients with
mantle cell lymphoma (MCL) compared to treatment with a standard therapy. These data were presented at
the annual meeting of the American Society of Clinical Oncology (ASCO). After a median follow up of 40
months, median overall survival (OS), a key secondary endpoint, had not been reached for patients who
received the Velcade-based therapy (Velcade, rituximab, cyclophosphamide, doxorubicin, and prednisone,
while a median OS of 56.3 months was observed in patients treated with the standard regimen (rituximab,
cyclophosphamide, doxorubicin, vincristine, and prednisone Overall, among patients receiving VcR-CAP
compared to R-CHOP, serious adverse events (SAEs) were reported in 38 per cent vs. 30 per cent of
patients, and grade =3 adverse events were reported in 93 per cent vs. 85 per cent of patients. "This is one
of the largest studies ever conducted in newly diagnosed MCL. The substantial improvement seen in
progression-free survival and in secondary endpoints, including complete response, time to next therapy
and time to progression with the Velcade-based regimen in newly diagnosed mantle cell lymphoma patients,
expands our understanding of Velcade’s contribution to patients with MCL," said Franco Cavalli, managing
director, director of the Oncology Institute of Southern Switzerland. "The 59 per cent relative improvement
in progression-free survival, along with the trend suggesting improved OS with the Velcade-based regimen,
has the potential to represent a significant advance in the frontline treatment of mantle cell lymphoma for
some patients," said Michael Vasconcelles, MD, Global Head, Takeda Oncology Therapeutic Area Unit.
"Patients with relapsed MCL have benefited from access to Velcade therapy since 2006. We look forward to
working with regulatory authorities to bring this new information to physicians and patients in the near
future." The open-label, multicenter, prospective study evaluated the efficacy and safety of VcR-CAP vs. RCHOP in 487 patients with newly diagnosed Stage II, III or IV MCL who were ineligible or not considered
for a bone marrow transplant. An Independent Radiology Review Committee (IRC) assessed the primary
efficacy endpoint. Key secondary endpoints for patients receiving VcR-CAP vs. R-CHOP included: 30.5 vs.
16.1 months median time to progression (HR 0.58; P<0.001) 44.5 vs. 24.8 months median time to
subsequent anti-lymphoma treatment (HR 0.50; P<0.001) 53 per cent vs. 42 per cent CR+CRu rate
(P=0.007).
AMGEN ANNOUNCES POSITIVE RESULTS FROM PHASE 2 PEAK STUDY OF
PANITUMUMAB VS BEVACIZUMAB IN COMBO WITH FOLFOX TO TREAT PATIENTS
WITH WILD-TYPE RAS MCRC
Pharmabiz, 3 June, 2014
announced results from the phase 2 PEAK study that reinforce the improved overall survival (OS) benefit
of panitumumab (Vectibix) when used in combination with Folfox, an oxaliplatin-based chemotherapy
regimen, compared to bevacizumab (Avastin) plus Folfox as first-line treatment in patients with wild-type
RAS metastatic colorectal cancer (mCRC). The data was presented at the 50th Annual Meeting of the
American Society of Clinical Oncology (ASCO) in Chicago The data presented at ASCO was an extended
analysis of the PEAK study that supports the use of panitumumab in combination with Folfox for patients
with wild-type RAS (absence of exons 2, 3, or 4 KRAS or NRAS mutations) mCRC. In this exploratory
analysis, patients who received panitumumab plus Folfox and were then treated with a VEGF inhibitorbased treatment (including bevacizumab) had a median OS improvement of 41.3 months. By comparison,
patients who received bevacizumab plus Folfox and were then treated with an anti-EGFR inhibitor-based
treatment (including panitumumab/cetuximab), had a median OS improvement of 29.0 months. For both
arms, outcomes were similar to those observed in the overall treated population with wild-type RAS
mCRC. "The initial PEAK data reinforce the potential importance of panitumumab for select patients, but
we wanted to evaluate whether this benefit was dependent on administration with Folfox and if other
subsequent treatments might impact survival outcomes," said Fernando Rivera, managing director, Medical
Oncology Department, Hospital Universitario Marques de Valdecilla, Santander, Spain, and a lead
investigator in the study.
ELI LILLY BEGINS SHARING OF
RESEARCHERS THROUGH WEBSITE
Pharmabiz, 4 June, 2014
CLINICAL
TRIAL
DATA
WITH
SCIENTIFIC
Eli Lilly and Company announced it will begin sharing its clinical trial data with scientific researchers
through www.clinicalstudydatarequest.com. This website, which houses data from several clinical trial
sponsors, was created in support of ongoing efforts by the Pharmaceutical Research and Manufacturers of
America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to
increase access to and transparency of clinical trial results with researchers around the world. "Scientific
advancements to improve patient care require the collaboration and creative thinking of researchers around
the world. Since our early partnership with academic researchers brought about the first commercial insulin,
we've continued to seek new ways to bring our internal expertise together with the high-quality research
being done beyond our walls," said Tim Garnett, managing director, senior vice president and chief medical
officer, Eli Lilly and Company. "By joining others in our industry to share clinical trial data with qualified
researchers, we can quicken the pace of scientific advances needed to make life better." The new portal,
www.clinicalstudydatarequest.com, differs from previous Lilly data-sharing sites in that access will only be
granted after approval of a research proposal by an independent scientific review panel. Lilly will not be
involved in the decisions made by the independent scientific review panel. The multi-sponsor portal will
include Lilly-sponsored interventional clinical studies from approved medicines and indications in the US
and EU in the following categories: Phase 2, 3 or 4 studies used as part of a regulatory approval submitted
to the U.S. Food and Drug Administration (FDA) on or after 1999; hase 2, 3 or 4 global studies with a first
patient visit after January 1, 2007; and Phase 2, 3 or 4 global or regional/local studies in indications
approved in both the US and EU with a first patient visit after January 1, 2014. All shared data on the
website are anonymised to safeguard patients' privacy.
IMMUNOVACCINE PRESENTS POSITIVE RESULTS FROM PHASE I/IB STUDY OF LEAD
CANCER VACCINE CANDIDATE, DPX-SURVIVAC AT ASCO 2014
Pharmabiz, 4 June, 2014
Immunovaccine Inc. (IMV), a clinical stage vaccine company, presented positive results from a phase I/Ib
clinical study of the company’s lead cancer vaccine candidate, DPX-Survivac, at the American Society of
Clinical Oncology (ASCO) 2014 Annual Meeting. In a poster presentation at the conference,
Immunovaccine highlighted promising early evidence of clinical activity for DPX-Survivac in ovarian
cancer patients. One patient, who experienced a 43 per cent reduction in tumour size, was classified as a
partial response (PR) as measured by Response Evaluation Criteria In Solid Tumours (RECIST 1.1). The
PR, which persisted following discontinuation of treatment, was accompanied by reduction in levels of a
commonly used ovarian cancer biomarker (CA125) and a significant increase in vaccine-induced immune
responses. The patient’s tumour and CA125 levels remain stable eight months following initiation of the
DPX-Survivac therapy demonstrating a potentially durable effect of the therapy. Additionally, patients
across all vaccine doses exhibited evidence of desired polyfunctional T cell responses against survivin, a
protein that is over-expressed in ovarian cancer and several other tumor types. Statistically significant
increases in immune response were achieved with higher doses of DPX-Survivac (p=0.013) and when
DPX-Survivac was combined with low dose oral cyclophosphamide (CPA) (p=0.015). A modified
vaccination schedule, reducing the dose for the first two vaccinations then boosting with a lower dose every
eight weeks, resulted in a lower frequency of local injection related adverse events. Importantly, robust
immune responses were produced with the modified immunization schedule, demonstrating the potency and
flexibility of DPX-Survivac. Finally, DPX-Survivac was well tolerated with no significant vaccine related
systemic adverse events reported
RESEARCH
ANTI-DIABETIC DRUG MAY SLOW AGING
Times of India, 4 June, 2014
Metformin, the world's most widely used anti-diabetic drug, may slow aging and increase lifespan, a new
study suggests. Researchers at the University of Leuven, Belgium decoded the mechanism behind
metformin's age-slowing effects:' the drug causes an increase in the number of toxic oxygen molecules
released in the cell and this, surprisingly, increas-' es cell robustness and longevity in the long term. 'As long
as the amount of harmful oxygen molecules released in the cell remains small, it has a positive long-term
effect on the cell. Cells use the reactive oxygen particles to their advantage before they can do any damage,"
said doctoral researcher Wou-terDeHaes. "Metformin causes a slight increase in the number of harmful
oxygen molecules. We found that this makes cells stronger and extends their healthy lifespan," he added.
The researchers studied metformin's mechanism in the tiny roundworm Caenorhabdi-tis elegans, an ideal
species for studying aging because it has a lifespan of only three weeks, pti
EXPOSURE TO LIGHT WHILE SLEEPING CAN MAKE YOU FAT: STUDY
Economic Times, 1 June, 2014
Exposure to greater levels of light while sleeping can make you pile on the pounds, a new study has
claimed. Scientists at The Institute of Cancer Research, London, found that body mass index, waist-hip
ratio, waist-height ratio and waist circumference in women increased with increasing exposure to light at
night. These associations were still seen after adjustments were made for confounding factors that could be
associated with light exposure levels and weight in the study participants, such as physical activity, having
young children and sleep duration. The findings come from cross-sectional analyses of data from the
Breakthrough Generations Study, the largest study of its kind, following more than 113,000 women from
across the UK for 40 years in a bid to find the root causes of breast cancer. "Metabolism is affected by
cyclical rhythms within the body that relate to sleeping, waking and light exposure," said Anthony
Swerdlow, Professor of Epidemiology at The Institute of Cancer Research, and co-leader of the study. "The
associations we saw in our study between light exposure at night and obesity are very intriguing. We cannot
yet tell at this stage what the reason for the associations is, but the results open up an interesting direction
for research," Swerdlow said. The findings were published in the American Journal of Epidemiology.
ICE CREAM OR CHOCOLATE WON'T BOOST YOUR MOOD
Times of India, 31 May, 2014
Rushing to gulp that chocolate ice cream may not actually boost your mood. In fact, we may simply feel
better after some time regardless of what food we eat, researchers say. "Whether it is your comfort food, or
it is a granola bar, or if you eat nothing at all, you will eventually feel better. Basically, comfort food can not
speed up that healing process," explained Heather Scherschel Wagner, a doctorate candidate from
University of Minnesota. During the study, participants were asked to pick foods that they thought would
make them feel better if they were in a bad mood. They were also asked to pick foods that they liked but
that they did not think would boost their mood. The participants then watched a 20-minute video intended
to elicit feelings of sadness, anger and fear. As expected, participants were in a bad mood immediately after
watching the video. Three minutes later, their mood improved, regardless of whether they had their comfort
food, another food, or no food at all. According to Wagner, it makes sense that people would attribute an
improvement in mood to something they ate, without realising that the food was not necessarily responsible
for the mood change. People like to find explanations for things, Wagner noted, adding that if people find
that they do actually feel better without eating comfort foods, that might stop the unhealthy pattern of
eating.
SLEEPING WITH LIGHTS ON CAN MAKE YOU FAT
Times of India, 2 June, 2014
A new study has revealed that sleeping with too much light in the room increases the risk of obesity in
women. Greater exposure to light at night raised both Body Mass Index (BMI) and waist size in more than
113,000 women taking part in the British study, scientists found. The Breakthrough Generations Study
followed the women for 40 years in an attempt to identify root causes of breast cancer. Obesity is a known
risk factor for the disease, News.com.au reported. Professor Anthony Swerdlow, from The Institute of
Cancer Research in London, said that metabolism is affected by cyclical rhythms within the body that relate
to sleeping, waking and light exposure.
SURGERY ON WEEKENDS UPS DEATH RISK
Times of India, 3 June, 2014
In a first that shows cyclic influences on hospital mortality in patients after surgery, a new research says that
the risk of death is the highest following surgery conducted on weekends, in the afternoon or in February.
During the analysis of the data from 218,758 patients, researchers found that surgery conducted in the
afternoon was associated with 21 percent increased risk of death compared with surgery conducted at other
times of the day. Surgery at the weekend was associated with a 22 percent increased risk of death compared
to surgery on weekdays. February was the highest risk month, with surgery in February associated with a 16
percent increased risk of death compared to surgery in all other months. Several factors may have
influenced this outcome. "For example, it may be that standard of care differs throughout the day and
between weekdays and weekends," said Felix Kork from Charite-University Medicine Berlin, Germany.
"Although we controlled for risk factors including emergency surgery in our study, it may very well be that
the patients treated in the afternoon and on the weekends were more severely ill," he explained. "We need
more data to draw conclusions regarding seasonal variation in postoperative outcome," Kork added.
USE ANTI-DIABETIC DRUG TO SLOW AGEING
Times of India, 3 June, 2014
Metformin, which is the world's most extensively used anti-diabetic drug, decreases ageing and increases
lifespan, says new evidence found by Belgian doctoral researcher Wouter De Haes (KU Leuven). The
researchers teased out the mechanism behind metformin's age-slowing effects: the drug causes an increase
in the number of toxic oxygen molecules released in the cell and this, surprisingly, increases cell robustness
and longevity in the long term. Mitochondria - the energy factories in cells - generate tiny electric currents
to provide the body's cells with energy. Highly reactive oxygen molecules are produced as a by-product of
this process. Wouter De Haes explained that as long as the amount of harmful oxygen molecules released in
the cell remains small, it has a positive long-term effect on the cell. Cells use the reactive oxygen particles
to their advantage before they can do any damage. Metformin causes a slight increase in the number of
harmful oxygen molecules. We found that this makes cells stronger and extends their healthy lifespan, he
added. The researchers studied the drug's mechanism in the tiny roundworm Caenorhabditis elegans, a
species which has a lifespan of only three weeks, and found that as the worms age, they get smaller, wrinkle
up and become less mobile. But worms which were treated with metformin showed very limited size loss
and no wrinkling, said Wouter De Haes.
EXERCISE SCORES OVER DIET IN LOWERING CANCER RISK
Times of India, 3 June, 2014
Are you on a strict diet to reduce body fat that may also help lower breast cancer risk? Better take up
exercise as researchers have found that physical activity offers additional benefit, beyond the effect of
weight loss in reducing cancer risk. Both exercising and eating better are thought to reduce women's risk of
breast cancer by decreasing body fat and levels of the sex hormones related to breast cancer. "Exercise has a
stronger effect on breast cancers fuelled by hormones, compared to dieting, and also offers additional
benefits such as preserving lean body mass," said Anne Maria May from University Medical Center Utrecht
in the Netherlands. "Exercise is the preferred weight loss strategy to decrease breast cancer risk," May
added. The study involved about 240 overweight women, aged 50 to 69, and they were set a goal to lose
five to six kgs over 16 weeks. By the end of the study, women in both the exercising and dieting groups
achieved their weight-loss goals, but the exercising participants preserved their lean body mass (which
includes muscles and bones), and reduced more of their body fat, compared with the dieting participants.
Those who exercised also reduced their levels of estrogen (a potential risk factor for breast cancer) more
than dieting participants did and the exercising women showed decreases in all types of estrogen in the
body, whereas women in the diet group showed a decrease in only one type of estrogen.
SMOKERS WITH GENE DEFECT HAVE LUNG CANCER
Times of India, 4 June, 2014
25 percent of smokers who carry a defect in the BRCA2 gene would be developing lung cancer at some
point in their lifetime, a large-scale, international study reveals. The defect in BRCA2 - best known for its
role in breast cancer - increases the risk of developing lung cancer by about 1.8 times. The researchers, led
by a team at The Institute of Cancer Research, London, compared the DNA of 11,348 Europeans with lung
cancer and 15,861 without the disease, looking for differences at specific points in their DNA. The team
was mainly funded by the US National Institute of Health, with additional support from Cancer Research
UK. The link between lung cancer and defective BRCA2 - known to increase the risk of breast, ovarian and
other cancers - was particularly strong in patients with the most common lung cancer sub-type, called
squamous cell lung cancer. The researchers also found an association between squamous cell lung cancer
and a defect in a second gene, CHEK2, which normally prevents cells from dividing when they have
suffered damage to their DNA. The results suggest that in the future, patients with squamous cell lung
cancer could benefit from drugs specifically designed to be effective in cancers with BRCA mutations. A
family of drugs called PARP inhibitors have shown success in clinical trials in breast and ovarian cancer
patients with BRCA mutations, although it is not known whether they could be effective in lung cancer.
SUGAR-HEAVY DRINKS UP FATTY LIVER DISEASE RISK
Times of India, 4 June, 2014
The key to preventing fatty liver disease, the most common cause of chronic liver disease worldwide, may
lie in avoiding sugar-sweetened drinks. Researchers have found that blocking a path that delivers dietary
fructose (fruit sugar) to the liver prevented mice from developing the condition. A molecule called GLUT8
carries large amounts of fructose, which is present naturally in fruit and is added to soft drinks and myriad
other products, into liver cells. Blocking or eliminating GLUT8 in mice reduced the amount of fructose
entering the organ and appeared to prevent the development of fatty liver. Mice with GLUT8 deficiency
also appeared to burn liver fat at a faster rate. "We showed that GLUT8 is required for fructose to get into
the liver," said Brian DeBosch from Washington University School of Medicine in St Louis, US. "If you
take away or block this transporter in mice, they no longer get diet-induced fatty liver disease," he added.
"If the fructose does not go into the liver, it may go to peripheral tissues," DeBosch noted.
AVG AGE OF PATIENTS WITH ORAL CANCER CAUSED BY TOBACCO DOWN TO 20-35
DNA, 31 May, 2014
Analysing the number of patients coming in with oral cancer caused by tobacco use, specialists at the head
and neck cancer department of Narayana Health City have concluded that there is a diminishing trend in the
age group of patients diagnosed with the ailment. Traditionally, it used to be people in the age group of 5060 years who were affected with oral cancer caused by tobacco use, but of recent, this has dropped to 20-35
years. Dr Vikram Kekatpure, senior consultant, head and neck surgery department, Narayana Health, said:
"About 30% of oral cancer cases we get today are in the age group of 25-35 years old and about 80% of the
cases detected are in stage 3 and stage 4, which is irreversible in most cases. Strangely, we are getting lot of
women with oral cancer from the lower socio-ecomic group comprising almost about 50%. All these people
might have got into the habit of tobacco use in the form of ghutka around 1990-2000." Easy access to
tobacco products is a major reason for youngsters picking up the habit and becoming early prey to oral
cancer. Hence, raising taxes on tobacco is the only way out to curtail consumption of tobacco, he asserted.
Meanwhile, a World Health Organization study have proven that increasing the price of tobacco through
higher taxes is the single most effective way to encourage tobacco users to quit and prevent children from
starting to smoke. The study has shown 10% increase in taxes on beedi would reduce the'consumption by
9.2% in rural India and 8.5 % in urban India. Hence, internationally it has been recommended to have a
uniform increase in taxes on all tobacco products to prevent users to switch from one product to another.
The World Bank recommends a 65% to 80% tax on tobacco products. Compared to the neighbouring states,
Karnataka has the lowest tax levied on tobacco products. Kerala, Andhra Pradesh and Tamil Nadu levy 20
% on cigarettes and in Maharashtra it is 25%. luna.dewan@dnaindia.net
DRUG COMBINATION MAY BE HIGHLY EFFECTIVE IN RECURRENT OVARIAN CANCER:
STUDY
Pharmabiz, 5 June, 2014
Significant improvement with the use of a combination drug therapy for recurrent ovarian cancer was
reported at the annual meeting of the American Society of Clinical Oncology meeting in Chicago. This is
the first ovarian cancer study to use a combination of drugs that could be taken orally. The drugs were
tested in a phase I combination study followed by a randomised phase 2 trial sponsored by the National
Cancer Institute (NCI), part of the National Institutes of Health. The trial compared the activity of a
combination of the drug olaparib (which blocks DNA repair) and the blood vessel inhibitor drug cediranib,
vs. olaparib alone. Trial results showed a near doubling of progression-free survival benefit (the length of
time during and after treatment that the cancer did not get worse) for the combination therapy over use of
the single drug alone. “The findings of this study are exciting because they support the idea that combining
these two targeted oral therapies results in significant activity in ovarian cancer, more so than olaparib
alone,” said Joyce Liu, managing director, M.P.H., the lead investigator and medical oncologist at the Susan
F. Smith Center for Women's Cancers External Web Site Policy at Dana-Farber Cancer Institute External
Web Site Policy, Boston. “We are looking forward to further exploring this combination in ovarian cancer
and potentially increasing effective treatment options for our patients with this cancer.” Over 22,000 cases
of ovarian cancer are diagnosed annually in the United States. Seventy-five percent of the cancers are
classified as high-grade serous type, the women have more advanced disease at diagnosis, and their tumours
are more aggressive. Of this high-grade type, about three-quarters of patients respond to initial treatment
but nearly all will recur and need follow-up treatment. That treatment will be based on how the cancers
have responded to previous therapies and are broken down into two categories based on patients’ responses
to chemotherapy regimens that include platinum: Platinum-Sensitive these are patients most likely to
benefit from Poly ADP-Ribose Polymerase (PARP) inhibition. PARP inhibitors, such as olaparib, are
targeted drugs that block an enzyme involved in many functions in the cell, including the repair of DNA
damage. Platinum-Resistant these are patients whose disease recurred within six months of completion of
conventional chemotherapy (using the drugs cisplatin or carboplatin) and are generally less responsive to
subsequent treatments and have not responded as well to PARP inhibitors.
NEW AND GENERIC DRUG APPROVALS
US FDA site
Drug Name
Strength
Methadose
10mg/Ml
Ms Contin
Reyataz
Mefenamic Acid
Oxycodone
Hydrochloride
Oxycodone
Hydrochloride
Dymista
Divalproex
Sodium
Kyprolis
Dosage Form /
Route
Concentrate;Oral
Marketing
Status
Prescription
Company
30mg; 60mg;
15mg; 100mg;
200mg
Eq 100mg Base;
Eq 150mg Base;
Eq 200mg Base;
Eq 300mg Base
250mg
Tablet, Extended
Release;Oral
Prescription
Purdue Pharma Lp
Capsule;Oral
Prescription
Bristol Myers Squibb
Capsule;Oral
Prescription
Vintage Pharms Llc
5mg
Capsule;Oral
Prescription
Lehigh Valley
5mg/5ml
Solution;Oral
Prescription
Vistapharm
Eq 0.125mg
Base/Spray;
0.05mg/Spray
Eq 250mg
Valproic Acid;
Eq 500mg
Valproic Acid
60mg/Vial
Spray,
Metered;Nasal
Prescription
Meda Pharms
Tablet, Extended
Release;Oral
Prescription
Aurobindo Pharma Ltd
Powder;Intravenou
s
Prescription
Onyx Pharms
Mallinckrodt
Reyataz
50mg
Powder;Oral
Prescription
Bristol Myers Squibb
Vistaril
Eq 25mg Hcl;
Eq 50mg Hcl
Eq 100mg Hcl
Capsule;Oral
Prescription
Pfizer
Capsule;Oral
Discontinued
Pfizer
Suspension;Oral
Discontinued
Pfizer
Cortenema
Eq 25mg
Hcl/5ml
100mg/60ml
Enema;Rectal
Prescription
Ani Pharms
K-Tab
10meq; 20meq
Prescription
Abbvie
Potassium
Chloride
Increlex
8meq
Tablet, Extended
Release;Oral
Tablet, Extended
Release;Oral
Injectable;Subcuta
neous
Tablet;Oral
Discontinued
Abbvie
Prescription
Ipsen Inc
Prescription
Glaxosmithkline
Injectable;
Subcutaneous
Injectable;
Subcutaneous
Solution,
Solution;Intraveno
us, Intravenous
Prescription
Amgen
Prescription
Amgen
Prescription
Hope Pharms
Tablet;Oral
Prescription
Strides Arcolab Ltd
Tablet;Oral
Prescription
Amneal Pharms
Injectable;Injection
Lilly
Vistaril
Vistaril
Prolia
40mg/4ml
(10mg/Ml)
Eq 200mg Base;
Eq 400mg Base
60mg/Ml
Xgeva
70mg/Ml
Nithiodote
300mg/10ml(30
mg/Ml),N/A;
N/A,12.5gm/50
ml(250mg/Ml)
0.125mg;
0.25mg; 0.5mg;
0.75mg; 1mg;
1.5mg
5mg; 10mg;
15mg; 20mg;
30mg
100 Units/Ml
Votrient
Pramipexole
Dihydrochloride
Oxycodone
Hydrochloride
Humulin N
30 Units/Ml; 70
Units/Ml
30 Units/Ml; 70
Units/Ml
100 Units/Ml
Injectable;Injection
Injectable;Injection
Over-TheCounter
Over-TheCounter
Over-TheCounter
Prescription
Humalog
Kwikpen
Humalog Pen
100 Units/Ml
Injectable;Injection
Prescription
Lilly
100 Units/Ml
Injectable;Injection
Discontinued
Lilly
Humalog Mix
75/25
Humalog Mix
75/25 Kwikpen
Humalog Mix
75/25 Pen
Humalog Mix
50/50
Humalog Mix
50/50 Kwikpen
Humalog Mix
50/50 Pen
Elidel
75 Units/Ml; 25
Units/Ml
75 Units/Ml; 25
Units/Ml
75 Units/Ml; 25
Units/Ml
50 Units/Ml; 50
Units/Ml
50 Units/Ml; 50
Units/Ml
50 Units/Ml; 50
Units/Ml
1.00%
Injectable;Injection
Prescription
Lilly
Injectable;Injection
Prescription
Lilly
Injectable;Injection
Discontinued
Lilly
Injectable;Injection
Prescription
Lilly
Injectable;Injection
Prescription
Lilly
Injectable;Injection
Discontinued
Lilly
Cream;Topical
Prescription
Valeant Bermuda
Fortesta
10mg/0.5gm
Actuation
Prescription
Endo Pharms
Byetta
300mcg/1.2ml
Gel,
Metered;Transder
mal
Injectable;Subcuta
Prescription
Astrazeneca Ab
Humulin 70/30
Humulin 70/30
Pen
Humalog
Injectable;Injection
Lilly
Lilly
Lilly
Prolia
(250mcg/Ml);
600mcg/2.4ml
(250mcg/Ml)
50mg; 100mg;
150mg; 200mg
500mg; 1mg;
500mg; 2mg
Eq 1gm
Base/50ml (Eq
20mg Base/Ml);
Eq 2gm
Base/100ml (Eq
20mg Base/Ml)
60mg/Ml
Xgeva
70mg/Ml
Levothyroxine
Sodium
100mcg/Vial;
200mcg/Vial;
500mcg/Vial;
500mcg
10mg; 25mg;
50mg; 75mg;
100mg; 150mg
50mg
Vimpat
Prandimet
Cefepime In
Plastic Container
Amitriptyline
Hydrochoride
Vogelxo
neous
Tablet;Oral
Prescription
Ucb Inc
Tablet;Oral
Prescription
Novo Nordisk Inc
Injectable;Injection
Prescription
Baxter Hlthcare
Injectable;
Subcutaneous
Injectable;
Subcutaneous
Powder;Intravenou
s
Prescription
Amgen
Prescription
Amgen
Prescription
Fresenius Kabi Usa
Tablet;Oral
Prescription
Accord Hlthcare
Gel; Transdermal
Prescription
Upsher Smith Labs