The Indian Pharmaceutical Association PHARMA PROFESSIONAL Vol. 61 April 2011 With the growth rate of 14 percent per year, the Indian pharmaceutical industry is well established for rapid expansion. Indian Pharmaceutical Industry has made phenomenal progress over the years and made Inside the Issue its impact in the global market. It has been recognized as a reliable source for drugs and drug intermediates and pharmaceutical formulations. With the strengthening of the IPR scenario in the quarter ended December Incountry, Focus:the Pharmacovigilance in India31, 2005 witnessed major changes in the Indian pharmaceutical industry like the foreign MNCs increasing their presence in India through expansions and collaborations; News IndianBrief companies competing with them through new product launches and gaining more number of regulatory approvals. Many (Clopidogrel) multinational companies have penetrated into India with an objective to Product Focus – PLAVIX marketing drugs and conducting clinical trials. Thus, Indian pharmaceutical research, manufacturing and outsourcing Stock Scan have received an impetus, thereby creating an image of a potential Pharma market and land of opportunities in the pharmaceutical division. Moreover the new Draft Drug Policy’ 2006 was released Upcoming Events during this quarter. In Focus: Pharmacovigilance in India Introduction Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines The protection of public health and adverse drug reaction. The major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India. This is an important and integral part of clinical research. Both clinical trials safety and post marketing pharmacovigilance are critical throughout the product life cycle. In India, pharmacovigilance has progressed from the situation as it was in past, but for different types of problems and limitations progress is yet not very rapid. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal Aims of Pharmacovigilance The Importance of effective drug monitoring systems for all medicines. The principal aims of pharmacovigilance are as follows To improve patient care and public health safety in relation to the use of medicines, and all medical and paramedical interventions To contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use Recent Uses Herbals Blood products Biologicals Medical devices Vaccines To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd. Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-05, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 1 Pharma Professional April 2011 Rs mn Pharmacovigilance in national drug policy The provision of good quality, safe and effective medi-cines and their appropriate use is the responsibility of national governments. The establishment of a national medicine regulatory agency and a designated other, regulators need to understand the specialized and pivotal role that pharmacovigilance plays in ensuring the ongoing safety of medicinal products. The aims of drug policy are as given below Establishment of national pharmacovigilance systems for the reporting of adverse events, including national and, if appropriate, regional pharmacovigilance centres. Development of legislation/regulation for medicine monitoring. National policy development (to include costing, budgeting and financing).Continuing education of health-care providers on safe and effective pharmacotherapy. Provision of up-to-date information on adverse reactions to professionals and consumers. To Monitoring the impact of pharmacovigilance through process indicators and outcome. Future Growth of Pharmacovigilance Japan is the second largest pharmaceutical Future Growth of market in the world, with an estimated 2500 Pharmacovigilance value in 2009 of 4% share of global sales. Japan has a reputation for relative slowness of drug approvals, where the approval lag is currently estimated to be between 2.5 and 3.5 years when compared 1500 with the US. The pharmacovigilance market is expected to grow 10%annually between 2009 and 2015. However, that pharmacovigilance spending will rise at a higher rate than this, as pharma companies 500 alter their current pharmacovigilance 2008 2015* practices to adhere to new and developing regulations. This will require a short Source: Cygnus Market Resources period of more significant investment from 2010 to 2012 before expenditure settles down. Pharmacovigilance is a developing field and, as such, regulations will continue to develop duringourforecastperiod.TheGlobalpharmacovigilance marker set to grow to $2.25 billion in 2015. West storms into India for clinical research, Pharmacovigilance next growth path for CROs India’s clinical research organizations are set for exponential growth going by the number of assignments. The global economic slowdown which has seriously impacted western world has benefited the Indian clinical research industry. The country is considered as a hub for clinical trials by pharma multinational companies primarily because of the diverse disease patient pool, scientific acumen, hospital infrastructure that help to provide the high quality and less expensive work. These aspects have made the recession hit international companies to off load assignments to India. Outlook Pharmacovigilance is a complex process and robust systems are essential to undertake the activity. The system needs to be refined with the help of pharmacovigilance experts in collaboration with information technology. With more and more clinical research now being conducted in India, it will be worthwhile for the DCGI to invest in a robust pharmacovigilance system, which will enable assessors and decision makers to analyze safety data and take regulatory decisions without the need to depend on other countries. Pharmaceutical companies will need to show both regulators and consumers that they are doing everything possible to assure drug safety, while finding more effective approaches to manage drug safety data. This will require the ability to pull and analyze data from adverse event reporting systems in conjunction with other internal company data or external data sources to respond to any ad hoc safety queries or issues from the regulators. India is now considered to be a hub for clinical research.More and more clinical trials are now being conducted in India and business process outsourcing based in India is now also undertaking pharmacovigilance projects from MNCs. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 2 Pharma Professional April 2011 News Briefs Marketing Americas USA: Affymetrix Launches NG Class Detergents for Superior Protein Analysis The company has launched its Anatrace brand Neopentyl Glycol Class Detergents, the next generation of detergents to significantly advance the study of integral membrane proteins the most important proteins found in the human genome. Developed by leading chemists, and available only from Affymetrix, the NG Class represents a new family of detergents based on the maltose-neopentyl amphiphile design first described in a study recently published in the journal Nature Methods1. The new NG Class was found to be more capable than current leading detergents, such as n-dodecyl-β-D-maltoside, in promoting crystallization of IMPs in preparation for structural and functional studies. USA: Olink Bioscience Introduces Its New Plasma Biomarker Discovery Service Olink Bioscience now offers a new research service, Plasma Biomarker Discovery Service. Using the multiplexed PLA immunoassay platform, up to 74 potential cancer biomarkers are analyzed with high sensitivity in precious biobanked plasma samples, in no more than 2 µl of sample. The Plasma Biomarker Discovery Service will help scientists in industry and academia to identify novel biomarkers and contribute to the understanding of human cancer and improved diagnosis. PLA has an industry leading sensitivity of multiplexed immunoassays while only consuming minute amounts of sample. Researchers can now access precious and limited biobanked serological materials and with our service find new protein biomarker signatures. The PLA immunoassay technology employs two primary antibodies linked to DNA strands which upon simultaneous and proximal binding to the target protein. USA: Valutek launches breathable cleanroom glove Valutek hopes new reusable cleanroom glove will help pharma researchers, wave goodbye to laboratory discomfort. Phoenix, US-based cleanroom equipment supplier Valutek says Operators have three common complaints: they are constrictive, causing hand fatigue; they are uncomfortable because they cause sweatiness; and they have a poor fit. There is no surprise that due to these factors, operators are constantly looking for any excuse to remove them, causing disruption and potential contamination in critical environments. The new gloves are designed to tackled just this type of problem and provide both the protection and flexibility required for pharmaceutical research and development. USA: Edwards Lifesciences buys Embrella Cardiovascular Edwards Lifesciences, a provider in the science of heart valves and hemodynamic monitoring, has completed the acquisition of Embrella Cardiovascular, the developer of the Embrella Embolic Deflector System, for approximately US$43m cash. The Embrella Embolic Deflector System can be used during transcatheter heart valve procedures. The single-use, disposable Embrella device is placed in the aorta through a sheath inserted in the right brachial or right radial artery and its porous membrane allows blood flow to the brain while simultaneously deflecting embolic material. The Embrella Embolic Deflector System has been assessed in a limited clinical study in Europe and received CE mark there in May 2010. USA: GEDC sets up new dental specialty center in Michigan Great Expressions Dental Centers has opened a new Specialty Center in Bloomfield Hills, Michigan, which will provide Endodontics, Periodontics, and Oral Surgery services to area patients. The Bloomfield Hills Specialty Center is GEDC's third specialty location in Southeast Michigan and compliments the two existing specialty locations in Livonia and Warren. In addition to the three specialty centers, GEDC has 47 locations in southeast Michigan. GEDC CEO says that continuing to provide their patients with convenient access to all dental services and specialties remains a top priority for them. GEDC is one of the privately-owned dental practice management companies in the US with 182 affiliated dental practices in seven states. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 3 Pharma Professional April 2011 USA: Surgeons test new device to treat diabetes, obesity Surgeons at Southampton General Hospital, UK, have performed 15 implants of a new device EndoBarrier to treat type II diabetes and obesity. Endobarrier is a small plastic sleeve which is placed into the small intestine through the mouth for up to 12 months. The device works by acting as a barrier between the food entering the stomach and the intestine, so that it cannot be absorbed. The barrier delays the mixing of digestive enzymes with the food and slows down the digestion process, which leads to greater control over metabolic rate and reduced sugar levels. Reportedly, in a 12-month study, patients receiving the EndoBarrier achieved weight loss of more than 20% of their total body weight. USA: AngioDynamics launches new Morpheus SMART PICC AngioDynamics has launched a new Morpheus SMART PICC bedside insertion kit and new 5 French Dual Lumen Peripherally Inserted Central Catheter as part of the continued growth of its Morpheus SMART PICC line. The Morpheus SMART PICC 5F Dual Lumen Smart PICC power-injectable catheter power-injectable catheter is designed to provide a superior flow rate of 5ml/second for purposes of CT imaging. The system's performance upgrade involves advanced catheter shaft technology, which couples the pushability needed for PICC placement with pliability that minimizes the risk of vessel trauma and phlebitis. The system also employs Smart Taper technology, which is designed to reduce the risk of thrombosis by allowing the catheter's diameter to quickly taper from seven French to precise five French. USA: Wright Medical releases PRO-TOE VO Hammertoe Fixation System Wright Medical Group has released PRO-TOE VO Hammertoe Fixation System, to offer a simple and efficient means to surgically repair the lesser toes following correction of a hammertoe deformity. The PRO-TOE VO Hammertoe implant provides a stable and efficient alternative surgical solution for the deformity. The new PRO-TOE VO Hammertoe System will be made available immediately in the US through Wright's specialized foot and ankle sales force. Additionally, the system will be marketed in select countries outside the US through Wright's direct and distributor-based sales representatives. The PROTOE VO Hammertoe System is the latest addition to Wright's suite of products for foot and ankle surgeons. USA: Orthovita to unveil Vitoss Bioactive Foam-2X Bone Graft Substitute Orthovita, an orthobiologics and biosurgery company, is planning to launch Vitoss Bioactive Foam-2X Bone Graft Substitute, non-structural bone void filler for use in the pelvis, extremities and posterolateral spine. Vitoss BA2X is the first in a series of new product introductions planned by Orthovita that is designed to meet the various bone grafting needs of patients, surgeons and hospitals. Orthovita president and CEO says Vitoss BA2X has the same structure and porosity of Vitoss BA but contains increased levels of bioactive glass. The in-vitro data indicate that the increased levels of bioactive glass double the overall bioactivity of the product. Other studies have shown that increasing the bioactivity leads to faster and more abundant bone formation. USA: Zoll Medical to install AED Plus devices at NSW Rural Fire Service stations Zoll Medical, a manufacturer of medical devices and related software solutions, has received the Government of NSW Australia award to provide 5450 AED Plus devices for installation on all Rural Fire Service stations deployed throughout the State of New South Wales. The installation of the Zoll AED Plus devices is part of a major public health policy initiative to make AEDs more accessible to the citizens of NSW when cardiac arrest occurs. The Rural Fire Service of NSW maintains fire protection and emergency services throughout the state through an organization of volunteers and professional members in brigades throughout the State. As part of the deployment, these employees will receive training in the use of the AED Plus for emergency defibrillation as well as use of its unique Real CPR Help capabilities to administer high-quality CPR. USA: HLL Lifecare Plans for Entering International Markets HLL Lifecare Ltd, the Kochi-based contraceptive manufacturer, has plans for foraying into the international arena, including Europe, Indonesia and Russia, for enhancing its sales. HLL Lifecare, known earlier as Hindustan Latex, has already started receiving orders for female condoms from Indonesia, A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 4 Pharma Professional April 2011 South Korea, Sri Lanka, Russia and Commonwealth of Independent States. HLL Lifecare came into existence in 2007 as the collaboration of HLL and Britain-based Female Health. The female condom division employs 20 people and can produce seven million female condoms annually. The central government is the company's largest consumer, with about 18 lakh pieces being procured last year. The female condoms come at a cost of Rs100 for a packet of 3. USA: Anacor Pharmaceuticals Launches New Treatments for Diarrheal Disease The joint research agreement is to discover antibacterial compounds for treating shigellosis. Shigellosis, or bloody diarrhea, is an infectious disease caused by the gram-negative bacterium Shigella. An estimated 80 to 165 million people worldwide are impacted by this disease annually, which is responsible for an estimated 600,000 deaths each year, mostly among children in the poorest countries. Current therapies are losing their effectiveness due to bacterial resistance, which demands the development of new medicines to ensure effective treatment against this deadly disease. One World Health received significant funding for this project from the Department for International Development in the United Kingdom for research and development of medicines to treat diarrheal diseases. USA: AstraZeneca and Galderma Enter into MoU to Develop Dermatological Diseases drugs They have entered into a R&D collaboration to develop new treatments for dermatological conditions including psoriasis, acne and atopic dermatitis which significantly affect the health and quality of life for millions of people worldwide. Under the terms of the agreement, Galderma will have exclusive access to a number of compounds from across AstraZeneca's portfolio to develop in dermatological indications. Initial targets for collaboration have already been identified from disease areas as diverse as oncology, inflammation and central nervous system. These will be interrogated based on translational science and pre-clinical testing to determine the ones that will progress in the collaboration. The financial terms of the five-year agreement were not disclosed. USA: GSK, Human Genome gear up for Benlysta launch Human Genome Sciences and GlaxoSmithKline are riding high on the news that Benlysta, the first new drug for lupus in more than 50 years, won FDA approval. Apart from being a treatment breakthrough, Benlysta stands to feed billions into both companies' revenue streams, with estimates for peak sales running at around US$2.3 billion to US$3 billion for the US and US$3.6 billion to US$5 billion globally. Benlysta's expected sticker price of US$35,000 per year is in line with other auto-immune disease treatments, it's still more expensive than older therapies, and payers may want to make sure patients aren't getting enough relief on cheaper drugs. Plus, while doctors were thrilled by the new treatment option, the prescription uptake could be slow at first as folks get an idea of how Benlysta works in the real world. USA: Amgen to buy Pfizer plant in Ireland, saving 280 jobs Amgen has agreed to buy a Pfizer manufacturing plant at Dun Laoghaire, County Dublin, securing 280 jobs in the process. The transaction is expected to close in the second quarter of the year. Under the terms of the agreement, 240 employees will transfer to Amgen the other 40 will remain employed by Pfizer. Amgen will manufacture Pfizer's products at the facility for an interim period. Pfizer will lease a portion of the facility from Amgen for the time being. Amgen intends to develop the capability to formulate and fill its biological products at the site and expand manufacturing capabilities. The 37,000 square-meter aseptic operations facility has freeze dry product and liquid vial filling operations. USA: Samsung plans $260M foray into drug manufacturing The drug makers diversify into other businesses; another business is diversifying into drug-making. Samsung Electronics says it will sock US$260m into a joint venture with Quintiles, aiming to make copycat drugs by the first half of 2013 and biosimilars by 2016. The joint venture plans to build a plant near Seoul, South Korea, where it first will produce biologic drugs on a contract basis. Later, the J.V. hopes to develop knock-offs of leading biotech meds such as Roche's blood-cancer drug Rituxan and Amgen's arthritis drug Enbrel. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 5 Pharma Professional April 2011 Europe UK: Biotronik launches AlCath Flux eXtra Gold in Europe Biotronik, a manufacturer of cardiac devices, has launched a new ablation catheter AlCath Flux eXtra Gold in Europe after receiving CE mark and completing the premarket evaluation in Germany, Italy, Switzerland and several other European countries. AlCath Flux eXtra Gold combines the advantages with the X-shaped irrigation configuration and the FullCircle deflection. The features of the AlCath Flux eXtra Gold facilitate optimal irrigation and building on the thermal properties of gold, the catheter tip's Xshaped configuration of the 12 irrigation channels further increases the cooling effect by more than 33% compared to the preceding model. Proximal cooling addresses the transition from tip to shaft to prevent charring during the procedure Asia-Pacific India: Proteonomix launches new subsidiary THOR BioPharma Proteonomix is focused on developing therapeutics based upon the use of human cells and their derivatives, has formed a new subsidiary, THOR BioPharma, based in Nevada, according to Fierce Biotech. THOR BioPharma has been established to gain Proteonomix entry into the bio-pharmaceutical market. Proteonomix plans to utilize THOR BioPharma as a platform for technology it will seek to license that focuses on pharmaceutical products. THOR Biopharma's mission is to develop therapeutic biological agents capable of enhancing stem cell therapies to provide clinical treatment of patients with debilitating diseases. THOR will focus initially on the licensing and development of therapeutic agents for critically ill patients. India: Fette sets up Goa tablet testing unit Fette Compacting has set up a tablet compression and flow ability testing centre in Goa, India. The unit, which cost €600,000 to set up according to the Machinist.in website, houses laboratories for small-scale compression trials, sample production, materials analysis as well as capabilities for proof of concept tablet studies. Fette’s Indian subsidiary, Fette Compacting Machinery India will manage operations which will also include a training centre at which pharma customers can gain hands on experience of the latest tabletting platforms. The centre is basically to support our clients in India, both the domestic and multi national pharma companies which have manufacturing facilities in India. FCI will enable the manufacturers to fit into the production line by installing the tool and pressing machines, which are either being imported from Germany or sourced locally. India: New chemicals units worth Rs80 billion on cards for GSFC Gujarat State Fertilizer and Chemicals Ltd is looking forward to develop certain chemicals as well as fertilizer manufacturing facilities at Dahej in order to meet the company’s demands because of its depleting units in Vadodara. The company would be investing an estimated budget of Rs80 billion to accomplish the same in a time span of coming three-four years. The plants would chiefly focus on procuring chemicals including melamine as well as caprolactam which is utilized in tyres and textiles industry as well as crockery industry respectively. A number of units by GSFC are as good as 43 years old, thereby making it necessary for GSFC to set up new facilities in order to keep the production smooth. India: Jubilant to establish two new plants at SEZ land in Bharuch The integrated life sciences and pharmaceutical firm, Jubilant Life Sciences Ltd is going to establish two new facilities at its special economic zone land in Bharuch of Gujarat for manufacturing chlorinated pyridine derivatives and Symtet by using pyridine based niche technology. Jubilant will be the only company in the world manufacturing symtet through this environment friendly technology, developed by in-house research and development having complete backward integration up to the basic feed stock. Through this technology Jubilant has identified additional use of pyridine. It will provide an innovative solution to its customers by providing a penultimate intermediate using single step chemistry leading to a better quality agrochemical product with higher yield. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 6 Pharma Professional April 2011 India: Natco Pharma third quarter profit up by 13% Natco Pharma has posted increase in net sales by 13 % to Rs137mn for the quarter ended December 31, 2010 as compared to Rs0.12 billion for the quarter ended December 31, 2009. The net sale for the company has decreased from Rs1089m for the quarter ended December 31, 2009 to Rs1073m for the quarter ended December 31, 2010, decreased by 1.7 %. With the increase in the sales of bulk chemicals to Rs3431m from Rs3226m by 12.1% rise during the first three quarter ended December 2010 and formulation also witnessed an upward trend of 3.9% to Rs546m against Rs525m last year for the same period. India: Fortune Names BASF Top Company in Global Chemical Industry BASF is ranked as the top company in the global chemical industry for the third year in a row. This is the result of a survey carried out by the renowned US business magazine Fortune and published in its latest edition. BASF is also ranked the world's most admired German company. The survey of the World's Most Admired Companies is conducted every year by Fortune in cooperation with the management consulting firm Hay Group. Industry experts rank around 700 companies worldwide in the categories of product and service quality, global competitiveness and quality of management. India: Hologic to launch 3D mammography system Hologic, a developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products is planning to launch its 3D mammography and other new, ready-to-market technologies. Hologic's Selenia Dimensions technology is the commercially available breast cancer screening and diagnosis system to detect breast cancer. Mammography systems using conventional 2D imaging have limitations caused by tissue overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious. In clinical studies, radiologists reading 2D plus 3D mammography compared to 2D mammography alone demonstrated superior clinical performance in specificity and also demonstrated improved sensitivity, the proportion of mammograms which include breast cancers that were correctly diagnosed. India: Boston Scientific Launches PROMUS Element and TAXUS Element Stent Systems Boston Scientific Corporation has launch of the PROMUS Element Everolimus-Eluting Coronary Stent System and TAXUS Element Paclitaxel-Eluting Coronary Stent System in India. Both Element Systems incorporate the same novel platinum chromium alloy, innovative stent design and advanced catheter delivery system, and represent the Company's third-generation drug-eluting stent technology. India is one of the fastest-growing DES markets in the world, with the number of coronary drug-eluting stents implanted annually estimated at more than 150,000.The new platinum chromium alloy and stent design of the PtCr Element Stent series represent significant innovations in DES technology. India: Medical equipment showroom opened spacious showroom that has on display various medical and health care equipment was opened by M.S. Enterprises in the CSI Shopping Complex on Prakasam Road. Hospitals, doctors and even ordinary customers can walk into the showroom to select from an array of medical devices like monitors, ultrasound sensors, endoscopes, surgical drills, tables, microscopes, lights, implants, nebulisers and aspirators. Also displayed in this spacious showroom are several specialised mechanical and automatic tables and beds. the business of supplying medical and healthcare equipment to hospitals and doctors all over the country with Vijayawada as the base. About 250 marketing staff went around the country demonstrating to hospital managements and doctors high quality medical equipment that were available in the market. India: Reliance Launches Its First Health Insurance Business Reliance Life Insurance has forayed into health insurance market with the launch of ‘Reliance Life Care For You’. Reliance Life Insurance announced the launch of the company’s first health insurance business Reliance Life Insurance Company forays into the health insurance market with the launch of its first pure reimbursement health insurance plan - Reliance Life Care for You Plan- for individuals and A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 7 Pharma Professional April 2011 family members. Reliance Life President and Executive Director say that the health insurance business was an extension of its life insurance business. ‘Reliance Life Care For You’ is our first step in the pure health Insurance space, aimed to help people meet their health care exigencies and expenses at every stage of life effectively. India: Fortis Healthcare Offers To Buy Parkway Holdings for US$2.3 billion India's Fortis Healthcare and its promoters have offered to buy all the shares of Singapore's Parkway Holdings for US$2.3 billion Parkway Holdings is a major player in health sector that operates 16 hospitals in the Asia-Pacific region. This is a major initiative by Indian based Fortis Healthcare. The Malaysian company offered the company's shares at Singapore S$3.78 per share. RHC Healthcare, a company jointly owned by RHC Holding Private Ltd., the holding company of, and Fortis Healthcare have announced a voluntary general offer for Parkway Holdings at an offer price of S$3.8 per share in cash. The offer represents a 25.8% over the closing price on May 26, the day prior to the announcement of the partial offered. India: Morgan Stanley Acquires 35,000 Shares in Parkway Morgan Stanley has purchased about 35,000 shares through FrontPoint Management in Parkway, a Singapore based hospital. FrontPoint Management is a part of Morgan Stanley. The shares were purchased at SGD 3.6 per unit. Now the company holds over 6 lakh shares in Parkway, the largest listed hospital chain in Asia. FrontPoint is an investment division of the Morgan Stanley. The company has recently purchased about 61,000 shares in Parkway and with this purchase; the company now totally owns about 6.34 lakh shares, according to sources. Currently, the company has very less stake in Parkway compared to the other holders. Malaysia’s Khazanah and Fortis holds majority stake in Parkway. India: Medicity to come up in Mullanpur near Chandigarh The Union Territory Administrator has already been held on extending proposed metro in Chandigarh to Mohali and Mullanpur, besides Panchkula. Speaking in presence of more than 100 top CEOs of companies based in the state the Deputy Chief Minister rued the alleged discriminatory attitude of Congress-led UPA regime towards Punjab and claimed that despite resurgent central taxes' collection, Punjab was getting only 1.32% of the generated revenue. India: GE Healthcare Launches Two Medical Equipments GE Healthcare has unveiled its two low-cost medical equipments, designed at its Bangalore facility. GE India President and CEO says that healthcare arm of General Electric has planned to spend US$2 billion to finance healthcare information technology in rural and underserved areas. It was also informed that the company will investment about US$6 billion on its global strategy. The two medical products launched in Bangalore include Lullaby Baby Warmer and LOGIQ P3. The first equipment has been designed to prevent infant deaths in developing countries. India: Apollo Hospitals Setting Up Stem Cell Research Centre in Gujarat Apollo Hospitals Group has its plans to establish a stem cell research institute in Gujarat. The 600 million projects is expected to be completed by the year end. According to a statement issued in Gandhinagar, the healthcare company has tied up with US-based StemCyte Inc, which specializes in stem cell therapy particularly for this project. The research facility will come up on 12 acres of land near the Cadila Pharmaceuticals factory on outskirts of Ahmedabad. Once the facility becomes fully operational, Cadila Pharmaceuticals is also expected to participate in the stem cell research. The company is going to establish five rural hospitals across the state and a nursing college near Gandhinagar. Apollo Hospitals is also planning to establish a total of 250 rural hospitals in the country in a phased manner. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 8 Pharma Professional April 2011 India: HLL Lifecare to Set Up 100 Hospitals across India By 2013 HLL Lifecare has entered into a joint venture with Acumen Fund USA to set up 100 hospitals across India by 2013. These hospitals will provide high quality service at affordable rates. Currently HLL Lifecare is running six Life Spring Hospitals that are working in Andhra Pradesh under joint venture. In the next fiscal they would set up another six hospitals in Andhra Pradesh, four in Maharashtra and are planning eight in Karnataka. The highlight of these hospitals is that a normal delivery would cost just Rs1, 499 which include the entire cost of medical care and two days of hospitalization. Caesarean deliveries would cost Rs5, 999, including five days in the hospital. HLL Lifecare is a mini ratna enterprise under the central health and family welfare ministry. India: GSK Pharma to launch vaccine cancer drugs in 2011 The Drugmaker GlaxoSmithKline Pharmaceuticals is to launch pneumonia vaccine Synflorix and at least two oncology drugs in 2011 as part of its strategy to drive sales in India. The two oncology drugs, Revolade and Votrient, would be launched by end of first quarter and also plan to introduce a couple of branded generics in cardio-vascular, metabolic diseases and high-end antibiotic segments, which will drive the growth in the current year. The Mumbai-based firm follows January-December fiscal and reported an 11.5% rise in December quarter net profit to 1.16 billion rupees on net sales of Rs4.91 billion. India: Surya Healthcare Buys Medimart Surya Healthcare, majority owned by Surya Pharmaceuticals, has bought Hyderabad-based Medimart Pharmacy, which runs 42 drug retail outlets in Andhra Pradesh, for Rs1.1 billion. Medimart gives us immediate presence in Hyderabad and we will use the platform to expand in South India the associate director and head retail at Surya Pharmaceuticals. Owned by a local doctor RR Reddy and few financial partners, Medimart Pharmacy has annual sales of around Rs1.6 billion but is making losses. The scrip of Surya Pharmaceuticals, which owns 60% in Surya Healthcare, remained almost unchanged to close at Rs22 at the BSE. The Chandigarh-based company aims to become the country's largest medicine retail chain in the 470 billion drug retail market dominated by about seven lakh standalone stores. India: Ipca Labs manufacturing unit gets UK health regulator's nod Ipca Laboratories and its formulations manufacturing unit at a Special Economic Zone in Indore has received the UK health regulator's approval for good manufacturing practices. The company's new formulations manufacturing unit at SEZ Indore has been inspected and certified for compliance with principles and guidelines of good manufacturing practices by the UK Medicines and Healthcare Products Regulatory Agency, Ipca Labs stated in a filing to the Bombay Stock Exchange. It is the fourth manufacturing unit of the company to have received such approval from UK MHRA. Ipca Laboratories is one of the leading manufacturers and exporters of active pharmaceutical ingredients (APIs) in the country. India: Asia is Key to Driving Innovation In Drug Development, Challenges Asia is rapidly becoming a new frontier for drug development as Western companies seek to develop and register their products, while emerging Asian companies seek new capabilities to globalize products. However, to fully capitalize on the opportunities, the industry will have to abandon its current model and move to a new model of drug discovery and development which embraces multiple strategic partnerships. The rapid ascent of Asia, with its access to fresh capital and willingness to discard old assumptions is injecting new life into global drug discovery and development, Within the changing landscape, we call the New Health, patient empowerment and market access considerations will be the drivers of innovation and a rebalancing of medical need and commercial considerations will occur. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 9 Pharma Professional April 2011 Operations Asia-Pacific India: Roche Buys Germany-Based Clinical Lab Automation Firm PVT for €65M Up Front Roche is buying Germany-based clinical lab automation firm PVT and its US sales and distribution subsidiary for €65 million up front, plus up to €20 million in performance-related milestones. The acquired firm specializes in the development of customized automation and workflow solutions for in vitro diagnostic testing in commercial and hospital laboratories. Roche says PVT’s products and expertise will bolster its position in the core laboratory field; a market it estimates was worth some US$15.3 billion in 2009. Once the transaction has been completed, PVT will become part of Roche’s Professional Diagnostics business and operate as a Roche center for competence in the development and manufacturing of automation products. India: Lanxess plans to shift its manufacturing base to Gujarat Lanxess, is considering to shift its existing production unit from Madurai, Tamil Nadu to another new site of company in Jhagadia, Gujarat in the time frame of a year. The decision comes into account as the company’s agreement with Speciality Products Pvt Ltd is about to expire by this June-end. The land at which the facilities are developed as well as a major section of the labourers working there belong to the Specialty Products. The facilities at present are indulged in making rubber additives along with leather chemicals. The Madurai plant has been serving as the manufacturing base for Lanxess to cater to its business in the Asia- Pacific region since the time it was developed in 1997. Investment Americas USA: West to invest in Kinston plant West Pharmaceutical Services will invest US$29m to expand its syringe plungers and intravenous system components facility in Kinston, North Carolina, in the US. West will spend the money on improving production processes and add new washing and inspection technologies. The firm told the Triangle Business Journal that the investment will include a contribution of as much as US$1.5m in state and local incentives and up to US$2m in investment tax credits. The firm did not say whether it will be adding to the facility’s 325-strong workforce. West plans to hire in the fields of microbiology and engineering as part of the new expansion programme. West has operated in the town since the mid 1970s however its original facility was destroyed in an explosion that killed six of its manufacturing employees in 2003. USA: Asahi Kasei Plastics Invests US$5.5m in Manufacturing, R&D and Services Asahi Kasei Plastics is undergoing a major expansion program to accommodate increased business with the Leona and Xyron engineering plastics product families. Production capacity will increase 30% with the addition of a new compounding line and peripheral equipment. Asahi Kasei Plastics is also adding an additional line in the lab for R&D, new product development and improved customer support. In addition to the latest state-of-the art equipment and technology, the US$5.5m investment supports 10 new jobs for skilled trades and support personnel. Asahi Kasei Plastics is also adding 6 new positions in sales, marketing and development to support growth opportunities. This investment comes on the heels of a US$3m investment in 2010 to upgrade existing production lines to accommodate the growing business. USA: Cadila Invest US$65m JV to set up plant in Rwanda CSM GlobalPharma has announced plans to invest US$65m in a manufacturing facility in Kigali, Rwanda in collaboration with the Rwandan Development Board. The firm, which is owned by India’s Cadila Pharmaceuticals and the US based Holtzman group, said it will invest US$64m in the plant, which will produce a range of dosage forms for the local market when fully operational in 2015. The plant will also make active pharmaceutical ingredients (APIs) and, in time, biologic drugs, injectables and vaccines to cater for the region’s rapidly expanding market. According to the RDB the new plant will help Rwanda achieve independence from most pharmaceutical imports by manufacturing high quality products A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 10 Pharma Professional April 2011 in-country for sale at competitive prices. Cadila already has a number of manufacturing interests in Africa including the joint-venture Cadila Pharmaceuticals Ethiopia that it set up in partnership with local manufacturing firm Almeta Impex. USA: Uganda’s QCI to invest US$80m in AIDS and anti-malarial drug capacity Ugandan drug maker Quality Chemicals Industries will invest US$80m in manufacturing operations to boost capacity for the production of generic AIDS and malaria drugs. The investment, which will take place over the next two years according to a Bloomberg report, will begin with a US$30m expansion of its facility in the capital Kampala with funding provided by shareholders and the sale of new stock. The second phase of the project, which will also be funded by shareholders, will see the addition of a brand new line for the production of pharmaceutical ingredients according to QCI marketing manager George Baguma who spoke with the newsier. Asia-Pacific India: GSK invests in Sri Lankan manufacturing plant GSK has invested in a new manufacturing plant in Sri Lanka for the production of its over-the-counter The INR200m facility in south western city of Moratuwa will house both laboratory space and production lines and, when operational early next year, will manufacture almost 2bn tablets a year. GlaxoSmithKline which sells around 70 million packs of Panadol in Sri Lanka every year told the Ceylon Daily News that the investment would roughly double production capacity. The company moved into Panadol liquid manufacturing and it is a great success adding that the aim with the new plant is to further secure supplies in the country. The new investment is to support the local manufacture of Panadol, which is the best selling analgesic in the country. India: StanChart PE invests Rs8.5 billion in Privi Organics The private equity arm of Standard Chartered Bank has invested Rs8.5 billion in Privi Organics, a Mumbai-based aroma chemical manufacturer and exporter. Most of the products manufactured by Privi Organics are used by fragrance and flavours companies. The company also exports products to over 25 countries. Privi is planning an expansion of its manufacturing facilities at Mahad in Maharashtra and the fund infusion will partly be used to finance this expansion. The specialty and fine chemicals market is pegged at US$860m and most of the products in this segment are used as additives in the textile, leather, paper, cosmetics and detergent industries. The global chemical industry underwent a major downturn during the recession. India: GE Healthcare to invest US$50m in India on new products The people will make an additional investment of US$50m in our India operations over the next 12-18 months to manufacture eight-ten medical devices that will be designed and custom-built for the local market," GE Healthcare Systems chief executive has informed The US$16 billion subsidiary of the USbased General Electric Company has eight research and manufacturing facilities across India where a range of high-tech medical equipment are designed and developed for the healthcare devices market. The people has plan to manufacture yearly 9-10 cost-effective medical devices for a range of diagnostic services, including anaesthesia, ventilation, CT systems to provide an early treatment, at the unveiling of its digital echocardiogram (ECG) system and cardiac ultrasound system. Mergers & Acquisitions Americas USA: Samsung Group, Quintiles to form biopharma venture Samsung says it will form a joint venture with a US company as the South Korean conglomerate expands further into biopharmaceuticals. Samsung says that three of its group companies are partnering with clinical research company Quintiles Transnational Corp. of the United States in a venture with initial capital of 300 billion won (US$266m). The Samsung companies, which include conglomerate flagship Samsung Electronics, will own 90% of the venture. Durham, North Carolina-based Quintiles will take 10%.The plans of the company for a factory to be constructed in South Korea that will produce biopharmaceutical drugs to treat cancer and arthritis. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 11 Pharma Professional April 2011 USA: Rambus, Toshiba renew licensing agreement Rambus which licenses its designs for memory chips and other technologies, says has renewed a patent license agreement with Toshiba Corp has sending shares surging in extended trading. The company did not disclose financial terms for the five-year agreement. Toshiba will pay royalties to Rambus based on shipment of certain types of memory controllers. Shares of Rambus jumped US$1.48, or 8%, to US$20.25 in after-hours trading. Earlier in the day, the stock slid 41 cents, or 2.1%, to close at US$18.77. USA: APEIRON Acquires Option Rights to Novel Oncology Compounds from Cleveland Apeiron Biologics AG announced that it has entered into an exclusive option to license from the Cleveland Clinic a number of novel compounds. These compounds are currently in development at Cleveland Clinic as drug candidates for treatment of various cancers, designed to fight cancer based on stimulation of the immune system. In preclinical models, they have shown anti-cancer activity and a favourable toxicity profile as orally available agents. This transaction follows in the wake of successful inlicensing deals that Apeiron completed in the last six months. USA: Daiichi Sankyo acquires first US-based packaging and manufacturing facility Daiichi Sankyohas announced the acquisition of its first US-based packaging and manufacturing plant. The company expects the facility, located in Bethlehem, Pennsylvania, to be fully operational in the summer or early autumn of 2011. It is expected to provide packaging solutions for a number of marketed products in DFI's portfolio, including Benicar, Welchol and Azor. According to DSI, the 140,000 square foot facility previously owned by global packaging firm, Amcor will enable it to “leverage existing resources to more cost effectively supplement its operations rather than build a new facility. USA: AltaGas Signs Processing Agreement with Nova Chemicals AltaGas has announced that it has entered into a definitive agreement with NOVA Chemicals Corporation for the Harmattan Co-stream Project. The processing agreement is for an initial term of 20 years and has AltaGas deliver all liquids or co-stream gas products on a full cost-of-service basis to NOVA Chemicals. The agreement provides that all capital expenditures and operating costs related to the proposed project will be fully recovered through fees under normal operations. They are pleased to complete this agreement with NOVA Chemicals. It further optimizes our existing base business with long term, stable cash flows and supplies NOVA Chemicals, a leading Canadian plastics and chemical company, with an incremental steady and cost-effective stream of ethane and natural gas liquids. USA: Hawkins Inc acquires bulk chemical manufacturer and distributor Vertex Chemicals Hawkins has says that they have acquired Vertex Chemicals, a leading manufacturer and distributor of sodium hypochlorite in the United States. The company also distributes significant volumes of caustic soda and hydrochloric acid. Vertex Chemicals, which in 2010 had revenues of around US$39m, has three strategic assets located in the Upper MidWest, MidWest and MidSouth regions of the country. The company was the first to bulk-tank truck deliver liquid caustic soda in the US in 1938 and has since constructed multi-million-gallon caustic storage tanks at its terminals. The company has large storage facilities for sodium silicate, aqua ammonia, potassium hydroxide, ferric chloride, and a wide range of acids including propionic, citric, hydrofluosilicic, phosphoric, hydrochloric, and sulphuric. USA: Melrob Group acquires Japanese specialty chemical distributor Melrob, a leading specialty chemicals distributor has announced the successful acquisition of Chemiplus Corporation located in Tokyo, Japan. Chemiplus specialise in the sales and distribution of fine, specialty and industrial chemicals. This strategic move reflects Melrob's commitment to growing its presence in the Japanese and Asia Pacific markets. The acquisition ensures both our customers and suppliers can benefit from our presence in Asia and Europe. Chemiplus management's long term relationships will prove beneficial to the Melrob Group. The existing management team will ensure further development of the business through their knowledge and experience across the region. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 12 Pharma Professional April 2011 USA: Cabot Signs Agreement with Risun for New China Carbon Black Manufacturing Cabot is a wholly-owned subsidiary of Cabot Corporation has entered into a joint venture with Risun Chemicals Company a wholly owned subsidiary of Risun Coal Chemicals Group, Ltd. Cabot owns a 60% equity interest in the new joint venture under the agreement. Additionally, Cabot and Risun will invest approximately US$100m to construct a state-of-the-art carbon black manufacturing facility in Xingtai City. The city is located about 250 miles south of Beijing in Hebei Province. This investment builds on our strong position in China, where demand for carbon black continues to grow. Cabot has been a successful supplier in China for more than 20 years. USA: Masimo, Royal Fornia Electronic Device sign licensing deal Masimo and Royal Fornia Electronic Device have signed a worldwide technology licensing agreement to integrate Masimo rainbow SET Pulse CO-Oximetry technology into Royal Fornia's new generation of multiparameter patient monitors. The integration enables advanced noninvasive blood constituent measurements that help clinicians to detect and treat life-threatening conditions earlier. Royal Fornia establishes itself as one of the first domestic Chinese medical device manufacturers to commercially incorporate Masimo's noninvasive blood constituent measurement capabilities. Masimo rainbow SET noninvasive and continuous measurements like total hemoglobin, oxygen content, carboxyhemoglobin, methemoglobin, and Pleth Variability Index. USA: Perrigo, AgaMatrix in pact for blood glucose monitors, test strips distribution Perrigo and AgaMatrix have entered into an exclusive agreement to sell and distribute blood glucose monitors and test strips in the US store brand channel.Under the agreement, Perrigo will sell and distribute certain products in the current AgaMatrix portfolio in addition to certain future new products.Perrigo will use its existing store brand retail channels to expand distribution of the new blood glucose meters and testing strips to consumers in early 2011, and also explore a complete range of diabetes care products beyond blood glucose monitoring. The strong demand for high quality and value in the growing diabetic community makes the deal with AgaMatrix, which has industry-leading quality and technology. USA: Mindray Medical to acquire Shenke Medical controlling stake Mindray Medical has signed an agreement to acquire a controlling stake of Shenzhen Shenke Medical Instrument Technical Development, a Chinese manufacturer of syringes, infusion pumps and infusion monitoring management systems. Infusion pumps are medical devices that deliver fluids, including nutrients and medications such as antibiotics, chemotherapy drugs, and pain relievers, into a patient's body in controlled amounts and are used in ICUs, pediatric offices, emergency rooms and operating rooms. Mindray expects to achieve synergies in the transaction by combining its strong engineering, manufacturing, sales and management platforms with Shenke's brand name, technology and expertise in the infusion pump area. USA: UWCCC in Madison to acquire ViewRay Radiation Therapy System The University of Wisconsin Carbone Cancer Center in Madison, Wisconsin, is planning to acquire a radiotherapy system from ViewRay, a privately held medical device company. ViewRay's new research radiation therapy system features a combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI). The ViewRay system is designed to provide continuous soft-tissue MRI during treatment so that clinicians can see precisely where the radiation is being delivered. ViewRay president and CEO says ViewRay system is designed to enable clinicians to plan and deliver precision radiotherapy and radio-surgery to treat lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. USA: Astellas, AVEO Pharma sign agreement to develop, commercialize tivozanib Astellas Pharma and AVEO Pharmaceuticals have entered into a worldwide agreement outside of Asia to develop and commercialize AVEO’s cancer drug tivozanib. Tivozanib is designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, for the treatment of a broad range of cancers. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 13 Pharma Professional April 2011 Under the terms of the agreement, AVEO will receive an initial cash payment of US$125m, composed of a US$75m license fee and US$50m in R&D funding. AVEO is also eligible to receive approximately US$1.3 billion in potential milestones comprised of US$575m in clinical and regulatory milestones, including US$90m in connection with the regulatory filings and market approval of tivozanib in RCC, as well as more than US$780m in commercial milestones. USA: Syntaxin Announces Partner Allergan Enters Phase II Trials for Endopeptidase Drug Syntaxin is developing novel biopharmaceuticals to control cell secretion, announces its partner Allergan, and has initiated two Phase II trials to evaluate the safety and efficacy of its re-targeted endopeptidase drug candidate AGN-214868. The Phase II trials will be focused on patients with post herpetic neuralgia and overactive bladder. With the initiation of Phase II trials, Syntaxin's drug technology platform reached a significant point of development and triggered an undisclosed milestone payment. AGN-214868 was discovered under the collaboration using Syntaxin's proprietary discovery platform. Under this agreement, Allergan is responsible for the clinical development, marketing and sales of identified drug candidates. Syntaxin receives milestone payments and royalties on product sales. USA: Pfizer Completes Acquisition of King Pharmaceuticals The company has announced that it has combined operations with King PharmaceuticalsPfizer completed its acquisition of King through the merger of its wholly owned subsidiary, Parker Tennessee Corp., with and into King. Under the terms of the transaction, each outstanding share of King common stock has been converted into the right to receive US$14.25, net in cash. Prior to the merger, Parker Tennessee Corp. acquired approximately 92.5% of the outstanding King shares through a tender offer. Effective as of the close of trading, King common stock ceased trading on the New York Stock Exchange. Europe Uk: Physio-Control, BeneChill partner for RhinoChill launch in Europe Medtronic's wholly-owned subsidiary Physio-Control and BeneChill have signed a strategic partnership to launch the RhinoChill IntraNasal Cooling System in Europe. RhinoChill is a non-invasive, portable system for transnasally cooling the head and lowering the body's core temperature immediately following cardiac arrest, stroke or traumatic brain injury.Initially, the partnership will focus on bringing the RhinoChill System to market in the UK, Germany, Austria, Switzerland, Belgium, Netherlands and Luxemburg during the first quarter of 2011, utilizing Physio-Control's extensive European distribution network. The strategic partnership with Physio-Control will ensure that our breakthrough RhinoChill cooling technology will be available for emergency and critical care health care professionals in the UK, The Netherlands, Belgium, Luxemburg, Austria and Switzerland. Asia-Pacific India: PDL BioPharma Settles Disputes with Novartis PDL BioPharma says that it has entered into a definitive settlement agreement with Novartis AG that resolves all disputes between the companies. Separately, the company says that it has adopted a regular dividend policy during 2011 and further ahead. The news sent PDL's shares up more than 17% in the morning trade. Under the settlement agreement, PDL agreed to dismiss its claims against Novartis in its action in Nevada court, which also includes Genentechand F. Hoffmann-La Roche Ltd as defendants. In addition, PDL agreed to pay Novartis certain amounts based on net sales of eye drug Lucentis made by Novartis during calendar year 2011 and beyond. From its part, Swiss drug maker Novartis agreed to withdraw its opposition appeal in the European Patent Office challenging the validity of PDL's Queen Patent in Europe. India: New acquisition follows for Camlin Fine Chemicals Camlin Fine Chemicals recently made a formal announcement declaring that the company has taken over Borregaard, an Italy-based chemical company. The company declared that after the acquisition is over, they are likely to have assured and steady supply of key raw material which at times remains in short A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 14 Pharma Professional April 2011 supply in the global market. At present, Borregaard is established as one of the key manufacturers of hydroquinone across the globe, which is an important ingredient for a number of chemical products. On the other hand, the company procured decent sales of Rs0.42 billion for the quarter ending December 2010, thereby reporting a significant jump of 28% in comparison to the corresponding period observed in last fiscal. The share price of the company, meanwhile, garnered a jump of 6.93%. India: Sprint, Ideal Life partner to enhance home health care Sprint and Ideal Life have entered into a partnership to develop, certify and co-market a version of the Ideal Life hub to transmit health data over the Nationwide Sprint Network. The transmitted data can include the patient's glucose, blood pressure, weight, heart rate and oxygen level. Ideal Life products are FDA approved for over-the-counter sales and HIPAA compliant for patient confidentiality. The partnership aims to expand Ideal Life's product portfolio to include embedded wireless devices. The agreement between Sprint and Ideal Life means that the entire system will work wirelessly utilizing Sprint's machine-to-machine platform and the Nationwide Sprint Network to transmit medical data to health care providers to support diagnosis and general monitoring India: Orchid Chemicals to Acquire US-Based Karalex Pharma Orchid Chemicals and Pharmaceuticals has announced that it would acquire US based Karalex Pharma.The Chennai-based Orchid Chemicals says that it would buy Karalex Pharma and the transaction would be completely through cash. Karalex Pharma is a US-based generic drug marketing company and with this acquisition Orchid Chemicals will be able to reach its generic drug to the US market. Orchid has established its presence in the generic sales and marketing area. This acquisition will provide a strong commercial US-based sales capability to Orchid, paving the way for synergistic returns from our upcoming and long-term strategic generic pharmaceuticals pipeline. India: Fortis Healthcare ties up with TotipotentRX These centres will undertake stem cell clinical research procedures relating to diabetes, cancer, cardiovascular disease, and neurological ischemia. TotipotentRX will also set up state-of-the-art cGMP laboratories in select hospitals, for processing stem cells before transplantation to patients. Fortis Healthcare and TotipotentRX will leverage Fortis’ hospital network and respective areas of clinical expertise to investigate new regenerative therapies, using promising adult stem cell sources like cord blood, bone marrow, and adipose tissue. As part of the alliance, a Stem Cell Medical Board will be created to oversee the medical research programme, ensure execution and monitor the progress following International and Indian ethical guidelines. The board will also impart training and create awareness around the benefits of stem cell therapy across India. India: Natco Ties Up With Dr Reddy's Laboratories for Development of Oncology Drugs Natco Pharma Limited has signed a pact with Dr Reddy's Laboratories Limited for the development, manufacture and supply of a basket of value-added generic oncology drugs. Dr Reddy's and Natco would together develop these products for registration and commercialization across the globe including markets of US and EU. Natco will exclusively supply the products to Dr Reddy's. The products selected under this agreement include currently selling oral and injectable innovator products. These products have multi-million dollar sales across the globe. One of the products is Paclitaxel, which is a generic version of Abraxane. According to the deal, Dr Reddy's would pay an undisclosed amount as upfront to Natco for securing rights to the product portfolio and capacity required to manufacture products Contracts Americas USA: OSI Systems secures Princeton HealthCare System contract OSI Systems Healthcare division, Spacelabs Healthcare, has received an approximate US$2.3m contract from Princeton HealthCare System. Under the terms of the agreement, Spacelabs will provide Ultraview SL patient monitors, Ultraview Telemetry, DM3 patient monitors and ICS G2 software applications for hospital-wide implementation. Spacelabs' ICS G2 software applications are designed to improve A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 15 Pharma Professional April 2011 efficiency, functionality and the flow of clinical information which in turn can help lower costs, reduce lengths of stay, and improve outcomes. OSI Systems CEO says they are proud that this highly respected teaching hospital relies on Spacelabs patient monitoring and connectivity solutions to assist them in delivering the best patient care. Others Americas USA: Remedent, Objet Geometries collaborate for digital cosmetic dentistry solution Remedent has teamed up with Objet Geometries to enhance the fabrication process for dental veneer tryins and delivery guides using Objet's 3D printing solutions. Using Objet 3D printing solutions, Remedent is able to create temporary clip-on veneers, also known as 'Try in Smile', allowing patients to realistically evaluate how their final ceramic veneers will look and feel before the order is placed. Objet Geometries Medical Solutions head says that using the Objet Eden 3D printing solution, Remedent is now able to rapidly manufacture high quality customized veneer models and delivery trays directly from their proprietary design software. Objet's 3D printing solutions provide dentists with a high level of precision that is otherwise difficult to achieve using traditional freehand dental techniques. London: Eating fish can reduce blindness risk by half Research shows that eating omega-3 fatty acids, most commonly found in tinned salmon and tuna, can help prevent the onset of age-related macular degeneration, a condition that leads to the gradual loss of vision. This finding backs up previous research which showed similar results in men. Of the Harvard fish appeared to help the most, the Telegraph reports. This lower risk appeared to be due, primarily, to consumption of canned tuna fish and dark-meat fish. The disease, which mainly affects people over 40, robs sufferers of their sight by creating a black spot in the centre of their vision which slowly gets bigger.With the number of AMD sufferers expected to treble in the next 25 years as the population ages, there is an urgent need for a breakthrough. Washington: Taking antioxidants during pregnancy prevents obesity in kids High-fat, high-carbohydrate diet causes oxidative stress during pregnancy, predisposing the offspring to obesity and diabetes, researchers at The Children''s Hospital of Philadelphia decided to study the effect of antioxidants before and during pregnancy in rats. The research may have implications for reducing obesity rates in children. Already know that there are critical periods during human development that influence the later development of obesity. They can prevent inflammation and oxidative stress during pregnancy; may lower the risk that a child will develop obesity. London: Combo therapy may overcome Herceptin-resistant breast cancer The Cancer Center found that adding the drug saracatinib to Herceptin treatment shrinks previously resistant tumours by cutting off at least five different molecular pathways, each of which can resist, Scientists have identified so many ways by which a tumour resists Herceptin that it raises an important issue for treatment and will have to give patients six drugs or 10 drugs to block them all The side effects would be awful. Two pills are better. This combination is a promising therapy for those with Herceptinresistant breast cancer. Asia-Pacific India: Endosulfan ban raises protest by pesticide makers The recent ban imposed on the use of Endosulfan by European Union has drawn strong criticism from The Pesticides Manufacturers and Formulator’s Association of India. The association has alleged that the ban promotes protectionism in the market and smacks of prejudices. Though the EU region accounts for only 8% of the world's agricultural land, it is a world leader in chemical and pesticide trade. However, its stake in the global Endosulfan market has reduced drastically over the years. Patented pesticides are being promoted by EU in recent years in order to replace the demand for Endosulfan. There are concerted efforts to manoeuvre trade through international conventions and trade restrictive practices. The PMFAI has clearly stated that the ban has been imposed to protect the crop protection industry of European Union which goes against the spirit of free trade. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 16 Pharma Professional April 2011 India: Glenmark gets most approvals to sell generic drugs in US Glenmark Pharmaceuticals has received the maximum number of approvals to sell low cost medicines in the US ahead of bigger peers such as Sun Pharma, Ranbaxy Laboratories and Dr Reddy's, that will support its revenue growth in the coming quarters. Glenmark secured nods to sell as many as 21 new generic medicines or low-cost versions of off patent drugs in the US, compared to 16 medicines by Aurobindo Pharma and 12 drugs by Sun Pharma, the top Indian generic firm to receive USFDA approvals for the year. The higher number of launch approvals does not guarantee a windfall compared to bigger peers as Glenmark does not have the first-to-file opportunities that would have given it an exclusive marketing rights for six months as also the fact that it targets medicines having lower annual sales India: Haryana pharma sector seeks reduction in VAT on drugs Haryana pharmaceutical industry has sought from state Finance Minister to reduce VAT on medicines and provide power at subsidised rate to boost the sector. In a memorandum submitted to Yadav, Haryana Pharmaceutical Association General Secretary says that the Union Finance Minister had not granted any relief to the entrepreneurs of the Haryana in general budget. the pharmaceutical industries had been paying 5.25% VAT on its production, while the neighbouring states like Himachal Pradesh and Uttarkhand had been charging simply 1 per cent sales tax on medicinal products. The employees demanded the sales tax on medicine should be brought on par with that of neighbouring states. Research & Development Americas USA: UCLA researchers create new cell lines from ocular melanoma patients The new tumor cell lines from fine-needle biopsies of ocular melanoma patients who had undergone treatment but died when their cancer spread aggressively. These new cell lines will afford scientists valuable insights into how the eye cancer causes rapid metastasis. The findings could lead to new methods for testing drugs for treatment. The scientists have had a limited number of models for studying ocular melanoma. The cancer does not naturally occur in animals, and commercially available cell lines may differ from the original tumor. Each cell line retained the molecular features found in its original tumor. Ocular melanoma, which forms in the pigmented layers under the retina, is the most common eye cancer in adults, with approximately 2,000 new cases diagnosed each year. USA: UCLA researchers develop new device to identify CTCs in the blood The device based on Velcro-like nanoscale technology to efficiently identify and grab these circulating tumor cells, or CTCs, in the blood. Metastasis is the most common cause of cancer-related death in patients with solid tumors and occurs when these marauding tumor cells leave the primary tumor site and travel through the blood stream to set up colonies in other parts of the body. The current gold standard for determining the disease status of tumors involves the invasive biopsy of tumor samples, but in the early stages of metastasis, it is often difficult to identify a biopsy site. The capturing CTCs in blood samples, doctors can essentially perform a liquid biopsy, allowing for early detection and diagnosis, as well as improved monitoring of cancer progression and treatment responses. USA: Scientists discover a new approach for bowel cancer treatment Cancer Research UK-funded scientists have discovered that blocking two cell DNA repair routes at once could provide a completely new way to treat bowel cancer and potentially other cancers. The team at The Institute of Cancer Research blocked the action of a protein called PINK1 in bowel cancer cells in the laboratory. PINK1 helps protect cells from DNA damage and blocking it caused an increase in DNA damage. The accumulative effect of losing both the PINK1 and MLH1 and MSH2 proteins causes DNA mistakes to build up to the point where the cancer cell dies. Faulty genes including MSH1 and MLH2 are found in the inherited condition Lynch Syndrome as well as non-inherited forms of bowel cancer. People with Lynch Syndrome have a significantly increased chance of developing bowel cancer. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 17 Pharma Professional April 2011 Europe UK: Salk researchers discover that stem cell marker regulates synapse formation The stem cell biologists there are few better-known proteins than nestin; whose very presence in an immature cell identifies it as a stem cell such as a neural stem cell. The study, Salk Institute of Biological Studies investigators led by Kuo-Fen Lee show that nestin has reason for being in a completely different cell type - muscle tissue. There, it regulates formation of the so-called neuromuscular junction, the contact point between muscle cells and 'their' motor neurons. By Knowing this not only deepens our understanding of signaling mechanisms connecting brain to muscle, but could aid future attempts to strengthen those connections in cases of neuromuscular disease or spinal cord injury. Exports Americas USA: China earmarks US$750M for building API exports Foreign companies may be scrambling to move into the Chinese drugs market, but China wants its own pharmaceutical firms to go in the opposite direction. The Global Times reports the Chinese government plans to invest more than US$750m to build up capacity to produce active pharmaceutical ingredients for drug makers in other countries. The goal is to grow API exports in a big way, president of the Chinese Pharmaceutical Enterprises Association. In the next five years, the government will assist some 60 producers in the sector with the goal of reaching international quality standards of manufacturing, and also help the sector realize total export volume of more than US$4 billion. FDA Approval Americas USA: Covidien Fentanyl Transdermal System patch obtains FDA approval Covidien, a global provider of healthcare products, reported that Mallinckrodt, a Covidien company, has received US Food and Drug Administration approval for its abbreviated new drug application for its Fentanyl Transdermal System patch. Covidien's FTS patch is a generic alternative to the branded DURAGESIC patch of Johnson and Johnson. FTS, a Class II controlled substance, is an opioid analgesic indicated in opioid-tolerant patients for management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediaterelease opioids. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 18 Pharma Professional April 2011 Product Focus – PLAVIX (Clopidogrel) Introduction Clopidogrel is an oral antiplatelet agent used to inhibit blood clots in coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It is marketed by Bristol-Myers Squibb and Sanofi-Aventis under the trade name Plavix, by Sun Pharmaceuticals under the trade name Clopilet, and by Ranbaxy Laboratories under the trade name Ceruvin. It works by irreversibly inhibiting a receptor called P2Y12. Drug Mechanism Clopidogrel is a pro-drug whose action may be related Drug Information to adenosine diphosphate receptor on platelet cell Brand Name Plavix membranes. The specific subtype of ADP receptor that clopidogrel irreversibly inhibits is P2Y12 and is Major Manufacturer Bristol-Myers Squibb & Sanofi-Aventis important in platelet aggregation and the cross-linking Drug Name Clopidogrel of platelets by fibrin. The blockade of this receptor Therapeutic segment Anti-coagulant inhibits platelet aggregation by blocking activation of the glycoprotein pathway. The IIb/IIIa complex functions as a receptor mainly for fibrinogen and vitronectin but also for fibronectin and von Willebrand factor. Activation of this receptor complex is the final common pathway for platelet aggregation, and is important in platelet aggregation, the cross-linking of platelets by fibrin. Platelet inhibition can be demonstrated two hours after a single dose of oral clopidogrel, but the onset of action is slow, so that a loading-dose of 300-600 mg is usually administered. Uses Clopidogrel is indicated for: Prevention of vascular ischaemic events in patients with symptomatic atherosclerosis Acute coronary syndrome without ST-segment elevation (NSTEMI), ST elevation MI (STEMI) It is also used, along with aspirin, for the prevention of thrombosis after placement of intracoronary stent Side Effects Get emergency medical help if the person has any of the following signs of an allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat. Stop using Plavix and call the physician at once if the person experiences any of following serious side effects: Nosebleed or other bleeding that will not stop Side effects Black, bloody, or tarry stools Stomach pain; Coughing up blood or vomit that looks like Runny or stuffy nose, cough, sore throat; or coffee grounds Mild headache or dizziness Chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or general ill feeling Sudden numbness or weakness, especially on one side of the body Sudden headache, confusion, problems with vision, speech, or balance Pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual Precautions Plavix keeps the blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. Because of this drug action, Plavix can make it easier for the person to bleed, even from a minor injury. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 19 Pharma Professional April 2011 Avoid drinking alcohol while taking Plavix. Alcohol may increase the risk of bleeding in the stomach or intestines. If the person needs to have any type of surgery or dental work, tell the surgeon or dentist ahead of time that the person is undertaking Plavix. The person may need to stop using the medicine for at least 5 days before having surgery, to prevent excessive bleeding. Market Scenario Plavix is marketed worldwide in nearly 110 countries, with sales of US$739 billion in 2009. In 2010, US$910m generic clopidogrel was briefly marketed by Apotex, a Canadian generic pharmaceutical company before a court order halted further production until resolution of a patent infringement case brought by BristolMyers Squibb. The Product promotion spending decreased by 15% to US$212m in the first quarter of 2010 and there will be a increase of sales in Rs$1000. Plavix, a leader in Europe and United States Revenue of Pravix from Sanofi Aventis has Source: Sanofi aventis Annual Report; Cygnus increased to £2616m in 2009 from £2367m in Research 2010It is currently commercialized in over 115 countries, including the United States, through an alliance with Bristol-Myers Squibb. It is backed by one of the largest clinical development programs in the world, involving more than 100,000 patients. Extremely well-positioned in treatment guidelines, Plavix performed very successfully in Japan in 2009 during its second year on the market, with sales of £182m. In the United States the federal Court of Appeals confirmed the validity of its compound patent expiring in November 2015. Generic Competition Up to 12 generic competitors have reportedly filed for approval to market versions of Plavix (clopidogrel bisulphate) in Europe, despite Sanofi-Aventis's main patent on the drug being valid until 2013. Swiss firm Acino has been marketing a generic version of Plavix in Germany since last August, sidestepping patent laws by mixing its active ingredient with a different salt. Other companies are now trying to mimic this formula to gain a slice of this lucrative market. Outlook The courtroom victory for brand-name Plavix raises serious questions about the future of both BMS and Sanofi-Aventis. The ruling is unquestionably good news for both firms, which should be able to look forward to several more years of US patent exclusivity on Plavix until it comes to the end of its patented life in late 2011. Despite of generic competition, sales of Plavix is estimated to show the growth of 1012% to reach £3.2 billion by the end of 2015. A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 20 Pharma Professional April 2011 Stock Scan 115 Relative Market Cap Performance 110 105 100 95 BSE Sensex Piramal C ipla 08/03/11 09/03/11 10/03/11 11/03/11 14/03/11 15/03/11 08/03/11 09/03/11 10/03/11 11/03/11 14/03/11 15/03/11 07/03/11 04/03/11 03/03/11 01/03/11 28/02/11 25/02/11 24/02/11 23/02/11 22/02/11 21/02/11 18/02/11 17/02/11 16/02/11 90 Relative Market Cap Performance 110 85 BSE Sensex SHASUN AUROBINDO 07/03/11 04/03/11 03/03/11 01/03/11 28/02/11 25/02/11 24/02/11 23/02/11 22/02/11 21/02/11 18/02/11 17/02/11 16/02/11 60 Source: BSE India; Cygnus Research Index BSE (Points) CIPLA (Rs) PIRAMAL (Rs) SHASUN (Rs) AUROBINDO (Rs) Index BSE (Points) CIPLA (Rs) PIRAMAL (Rs) SHASUN (Rs) AUROBINDO (Rs) 1st Week (16-23 Feb 2011) Opening Closing Var(%) 18,300.90 18,178.33 -0.67 306.35 303.00 -1.09 423.35 446.50 5.47 55.95 56.10 0.27 241.10 204.95 -14.99 2nd Week (24th Feb - 1st Mar 2011) Opening Closing Var(%) 17,632.41 18,489.76 4.86 302.10 306.10 1.32 438.65 465.70 6.17 53.40 59.20 10.86 170.50 176.50 3.52 3rd Week (02nd - 8th Mar 2011) Opening Closing Var(%) 18,486.45 18,327.98 -0.86 304.15 299.85 -1.41 463.30 460.30 -0.65 61.10 54.50 -10.80 183.55 196.60 7.11 4th Week (9-15 March 2011) Opening Closing Var(%) 18,174.09 18,167.64 -0.04 295.10 297.60 0.85 465.00 469.10 0.85 52.95 51.30 -3.12 189.05 187.75 -0.69 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 21 Pharma Professional April 2011 Upcoming Events 1. Event Date Venue Highlights 2. Contact Details Event Date Venue Highlights 3. 4. Contact Details Event Date Venue Highlights Contact Details Event Date Venue Highlights Contact Details 5. Event Date Venue Highlights Contact Details Bangalore Bio May 04-06, 2011 TBA Bengaluru, India It will offer an unrivalled opportunity in Asia Pacific region to meet with the who's who of the Biotech world in one place at one time, nearly over 600 delegates, 72 speakers, 150 exhibitors participated in this event. M. M. Activ, Bangalore, UNI Building, Thimmaiah Road, Millers Tank Bund, Bengaluru, India. Tel: +(91)-(80)-41131912; Fax: +(91)-(80)-41131914 International Pharmaceutical Exhibition May 10-12, 2011 Charlotte Convention Center It will provide an excellent platform for service providers to showcase their products and services to decision makers from leading Pharmaceutical manufacturers. It offers pharmaceutical and biotechnology scientists and practitioners the opportunity to interact, network and exchange ideas for the betterment of the profession and bring themselves and their organization to the forefront of the discipline. Arosa Exhibitions Limited 12019 Belmont Walk Way, Charlotte, USA Tel: +(1)-(980)-2198449 International Healthcare Exhibition May 10-12, 2011 Charlotte Convention Center It will bring together all the key players under one roof, providing exhibitors with a compelling networking opportunity-to precisely target relevant budget-holders in the shortest time possible and at an affordable cost. It will be targeting Diagnostic products, Pharmaceutical products, Specialty Hospitals, Natural Products, and Herbal Medicines. Arosa Exhibitions Limited12019 Belmont Walk Way, Charlotte, USA Tel:+(1)-(980)-2198449 Vietnam Medi-Pharm Expo-Hanoi May 11-14, 2011 Hanoi International Center for Exhibition (I.C.E. Hanoi) The Ministry of Health hosts and assigns to Vietnam Medical Products Import Export J.S Company VIMEDIMEX Vietnam and Vietnam Advertisment and Fair Exhibition Company to organize and have been successfully for last 17 editions since 1994 to now. Vietnam Advertisement & Fair Exhibition Company, 5/F, Bien Phong Newspaper Bldg., 40A Hang Bai Street, Hoan Kiem Dist., Hanoi, Vietnam Tel:+(84)-(4)-9365566; Fax:+(84)-(4)-9365568 EuroMedtech May 16-17, 2011 Centro Congressi Torino Incontra It is the only event which focused on helping companies forge partnerships across the entire medtech value-chain. The event builds on the success of its predecessor, BioDevice Partnering, to enable executives to efficiently identify and meet with strategic partners that spur innovation and drive future profits. E.B.D. Group, Inc., 2032 Corte del Nogal, Suite, Carlsbad, United States Of America. Tel: +(1)-(760)-9300500; Fax: +(1)-(760)-9300520 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 22 Pharma Professional 6. Event Date Venue Highlights 7. 8. Contact Details Event Date Venue Highlights Contact Details Event Date Venue Highlights Contact Details 9. Event Date Venue Highlights 10. Contact Details Event Date Venue Highlights Contact Details April 2011 Medical Electronic Device Conference & Expo May 16-18, 2011 Navy Pier Chicago, United States Of America It was developed to deliver unprecedented access to engineering solutions and innovations for the medical device community. Knowing where the FDA & FCC are heading with tele health, 501(K) and documentation for certification of Class II & III devices. IQPC Worldwide Pte. Limited, 1, Shenton Way, No.13, Singapore Tel:+(65)-(6)-7229388; Fax:+(65)-(6)-2242515 LogiChem Asia May 18-20, 2011 Singapore Grand Hyatt Singapore, Singapore It is the only dedicated chemical supply chain event in the Asia region. This business meeting provides preliminary networking opportunities for supply chain professionals to exchange their experiences with peers and learn best practice from leading industrial experts. Worldwide Business Research, 535, Fifth Avenue, 8th, New York, USA Tel:+(1)-(888)-4826012; Fax:+(1)-(212)-8852798 ILSI Biomed Israel May 23-25, 2011 David Intercontinental Tel Aviv, Israel It is a renowned event for giving a complete view of biotechnology and medical devices. Held at David Intercontinental Hotel, Tel Aviv, Israel, it is a comprehensive event for giving an out view of medical fraternity. Kenes Exhibitions Organizers of Exhibitions Limited, Kenes Building, Airport City 70151 P. O. Box 56, Ben-Gurion, Israel Tel:+(972)-(3)-9727557; Fax:+(972)-(3)-9727588 FCE Pharma May 24-26, 2011 Transamerica Expo Center Sao Paulo, Brazil CEOs & Top executives from Pharma Manufacturing Industry, Executives from Production, Quality Control, R&D & Purchase Departments, Professionals from R&D Institutions, Pharmacists from Trade and Profession, Biotechnology Specialists, Top officials from Regulatory Agencies of Central & State Governments, Pharma consultants, Academicians from Medical and Pharmacy Colleges are the target visitors. Nurnberg Messe Brasil, Rua Verbo Divino, 1547 - 7th Floor, Sao Paulo, Brazil Tel:+(55)-(11)-32055000 China International Pharmaceutical Machinery Exposition May 29 – 01 Jun, 2011 Shenyang International Exhibition Center Shenyang, China It has been held for 39 times in more than 20 cities in China since the year of 1991. This exposition combines product demonstration, technical exchange, technicaleconomic corporation as well as trading into one. It is one of the important expositions supported by Ministry of Commerce of the Peoples’ Republic of China. China Association For Pharmaceutical Equipment, No. 4, Yi Qu, Xin Yuan, Caoqiao, Fengtai District, Beijing, China. Tel:+(86)-(10)-87583591 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 23 Pharma Professional 11. 12. Event Date Venue Highlights Contact Details Event Date Venue Highlights Contact Details 13. Event Date Venue Highlights 14. Contact Details Event Date Venue Highlights 15. Contact Details Event Date Venue Highlights Contact Details April 2011 Chemspec Europe Jun 15-16, 2011 Geneva Palexpo Geneva, Switzerland It goes from strength to strength as the only dedicated event targeted at and delivering high quality custom, fine and speciality chemicals professionals. Chemspec continues to grow, welcoming more visitors and exhibitors from Europe, Asia, USA, North Africa and the Middle East, ensuring our exhibitors receive the widest possible exposure. Quartz Business Media Limited, Kevin Lloyd, Westgate House, 120/130 Station Road, Surrey, Guildford, United Kingdom; Tel: +(44)-(310)-7064150 Dye+Chem Bangabandhu International Conference Centre Dhaka, Bangladesh Jul 20-23, 2011 It will be one of the biggest meeting place in Bangladesh for Buyers and Suppliers of Dyes and Chemicals. it will also provide an interactive platform for Exhibitors to generate business through displays/direct interaction and will enhance the synergy effect and attract top level professionals from the Industry thus improving technology, focus and visitors of the expo. Conference and Exhibition Management services Limited House # 119, Unit- A3, Road-1, Banani Block-F, Dhaka, Bangladesh. Tel: +(880)-(2)-8812713; Fax: +(880)-(2)-9894573 Meditec Clinika Jul 02-04, 2011 Palace Grounds Bengaluru, Karnataka, India It is to act as a catalyst to bring together a varied genre of medical professionals under one roof to interact, promote and transact business in this industry which will eventually lead to better healthcare for the common man in this densely populated region. All visionary companies and individuals are invited to constructively contribute to becoming a part of this congregation and profit from interaction at this platform for a common goal to equally distribute medical technology in all regions of the world. Orbitz Exhibitions Pvt Ltd, 202, Navyug Industrial Estate, Sewree, Mumbai - 400 014, India; Tel: +(91)-(22)-24102801; Fax: +(91)-(22)-24102805 Healthex Aug 05-07, 2011 Bangalore International Exhibition Centre (BIEC) Bengaluru, India The show presents a complete range of equipment, materials, services, processes, systems, components, consumables which find wide use in medical surgeries, hospitals, clinics, and diagnostic centres from across the world. Confederation of Indian Industry, Plot No. 249-F, Sector-18, Udyog Vihar, PhaseIV, Gurgaon, India; Tel:+(91)-(124)-4014060; Fax:+(91)-(124)-4014088 Medicall Aug 12-14, 2011 Chennai Trade & Convention Centre Chennai, Tamil Nadu, India Exhibited products and services can be categorized as Hospital Information System, solutions, surgical and examination furnitures, rescue and emergency equipment, medical disposables, cleaning equipment, rescue and emergency equipments and others. The show proves to be a highly successful point in attracting affluent producers, dealers, suppliers Medexpert Business Consultants Pvt. Ltd., C-3, Shree Vidya Apartments, 14, Balakrishna Street, West Mambalam, Chennai - 600 033., India. Tel: +(91)-(44)-24718987 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 24 Pharma Professional 16. Event Date Venue Highlights 17. 18. Contact Details Event Date Venue Highlights Contact Details Event Date Venue Highlights 19. Contact Details Event Date Venue Highlights Contact Details 20. Event Date Venue Highlights Contact Details April 2011 Pack Tech Asia Aug 27-29, 2011 Milan Mela Ground Kolkata, India it is a International Exhibition on processing, filling & packaging technology will showcase the entire spectrum of products, latest Trend, Technology equipments & services in food processing, pharmaceuticals, beverages, confectionery, bakery, Ayurveda and Herbal products, Cosmetics, Agro Products and many more. Kesari Media & Events Pvt. Ltd, Scf 172-A, First Floor, Grain Market Sector-26, Chandigarh, India. Tel:+(91)-(172)-2790007 ChemInnovations Sep 13-15, 2011 George R. Brown Convention Center Houston, United States Of America It is titled as biggest event for Chemicals & Dyes. It is the international event which gives a view of hemical Apparatus and plant installation, Chemical process tech, maintenance and QC, Environmental Protection, Petrochemistry during 3 days of event. The TradeFair Group, Inc., 11000 Richmond, Suite, Houston, USA Tel:+(1)-(832)-2421969; Fax:+(1)-(832)-2421971 Pharmac India Sep 17-19, 2011 Gujarat University Exhibition Hall It is recognized as a focused exhibition for Pharma & Health care industry. It is 3 days exhibition which is aiming towards highlighting varied related medical products. It will prove to be a large hub of reputed professionals from pharmaceutical formulation, herbal products, veterinary drug, medical & disposal, pharmaceutical machinery and many other sectors. Orbitz Exhibitions Private Limited, 202, Navyug Industrial Estate, T. J. Road, Sewree, Mumbai, India; Tel:+(91)-(22)-24102801; Fax:+(91)-(22)-24102805 India Chem Gujarat Oct 13-15, 2011 Gujarat University Exhibition Hall Ahmedabad, Gujarat, India It will showcase potential of the chemical and allied industry. The exhibition will offer a platform for discussing varied areas of the sector along with the environmental concerns. The event is being organized by Federation of Indian Chambers of Commerce and Industry. Federation of Indian Chambers of Commerce & Industry, Federation House, 1, Tansen Marg, New Delhi - 110 001, India. Tel: +(91)-(11)-23738760; Fax: +(91)-(11)-23320714 MEDTEC India Oct 19-20, 2011 Grand Hyatt Mumbai Mumbai, India It is the one of the largest show for the medical community involving in the manufacturing of the medical equipment world wide. Large number of peoples will be come from domestic and internationally at Medtec India Show. The participants will also get latest information about the goods and techniques which are being used in the field of medical industry. Canon Communications Llc.11444 W. Olympic BLVD., Ste. 900, Los Angeles, United States Of America. Tel:+(1)-(310)-4454200; Fax:+(1)-(310)-4454299 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 25 Pharma Professional 21. Event Date Venue Highlights Contact Details 22. Event Date Venue Highlights Contact Details 23. Event Date Venue Highlights Contact Details 24. Event Date Venue Highlights Contact Details 25. Event Date Venue Highlights Contact Details April 2011 P-Mec India Nov 30 – 02, Dec 2011 Bombay Exhibition Centre(BEC) Mumbai, India it is a Pharmaceutical-Machinery & Equipment Convention is the exhibition for the supplier of quality equipment and machinery for pharmaceutical manufacturing industry. It will provide the opportunity to showcase their latest accomplishments in pharmaceutical machinery and equipment. It will be held alongside the ICSE and CPhI events, offering complete coverage of all developments in the pharmaceutical word. UBM India Pvt. Ltd., Sagar Tech Plaza A, 615-617 6th Floor, Andheri Kurla Road Saki Naka Junction, Andheri East, Mumbai, India Tel:+(91)-(22)-66122648; Fax:+(91)-(22)-66122626 Industrial Green Chemistry World Dec 04-06, 2011 TBA Mumbai, India It is a global platform for the Chemical Industry to explore, engage and exchange emerging trends and innovations implemented in the field of Industrial Green Chemistry and Engineering, for promoting, Green Chemistry and Green Engineering (GC&E) practices amongst diverse sections of societies, like: Industry, Govt. bodies, Research Institutes, Academia, Students and others. Newreka Green Synth Technologies Private Limited, 405, Mastermind Iv, Royal Palms, Aarey Colony Goregaon (East), Mumbai, India. Tel: +(91)-(22)-28791835; Fax: +(91)-(22)-28794790 India Lab Expo Dec 08-10, 2011 Pragati Maidan New Delhi, Delhi, India It is the India's unique and most comprehensive exhibition on Laboratory, Scientific, Biotechnology, Analytical, Educational, Material Testing, Diagnostics & related products for major Indian and International manufacturers, exporters, importers and key regional suppliers. This international trade exhibition focuses on latest laboratory technologies and accessories. It is an ideal platform as a meeting ground for scientists, researchers, institutional heads and industry captains, to look at viable laboratory solutions S. D. India Corporation, No. 595, 2nd Floor, Dr. Mukherjee Nagar, New Delhi - 110 009, India. Tel: +(91)-(11)-27604500; Fax: +(91)-(11)-27604600 Hospital Infrastructure India Dec 14-16, 2011 Bombay Exhibition Centre (BEC) Mumbai, India It is an India's premier international exhibition on hospital infrastructure, planning, supplies and health care development sector. This exhibition will be the sole platform where Investors, Planners, Builders, Contractors, Architects and Designers will meet senior managers and commissioners of healthcare facilities in India. IIR Exhibition India, 751, 5th Floor, Bldg 7, Solitaire Corporate Park, Andheri East, Mumbai, India; Tel:+(91)-(22)-40203329 Medifest India Dec 15-17, 2011 NASC Complex New Delhi, India It is an International Trade Fair and a unique opportunity for all related to medicine and healthcare field to reach new horizons of effective cooperation and discuss vital issues that stand presently in front of medical and healthcare industry. Vantage Trade Fairs (P) Limited, 38/16, 3rd Floor, East Patel Nagar, New Delhi, India. Tel:+(91)-(11)-25757181; Fax:+(91)-(11)-25757180 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 26 Pharma Professional 26. Event Date Venue Highlights Contact Details April 2011 Asicon Dec 25-30, 2011 Kochi Hotel Le Meridien Kochi, India The 71st Annual Conference of the Association of Surgeons of India (ASICON 2011) is scheduled for 25th- 30th December, 2011 at the Le Meridien, Kochi. Medical experts from different fields will be a part of Asicon to attend the conference and know about the Indian surgery. The conference will be a platform for medical professionals to meet the experts in the medical surgery field and built contacts. Association of Surgeons of India, Room No. 5010C, Teaching Block, Ansari Nagar, New Delhi, India. Tel:+(91)-(11)-26593460 A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more successful Indian Pharmaceutical Association Kalina, Santacruz (E), Mumbai – 400 098. Tel: 91-22-26671072; Fax: 91-22-26670744, Email:ipacentre@ipapharma.org:: www.ipapharma.org Cygnus Business Consulting & Research Pvt. Ltd Plot No: 8-3-948/949, 1st Floor, Solitaire Plaza, Behind Image Hospital, Ameerpet, Hyderabad- 500 073. Tel: +91-40-23430203-07, Fax: +91-40-23430201, Email: info@cygnusindia.com; Website: www.cygnusindia.com 27