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Contents
Opportunity for China and India Top Pharma Layoffs New Jobs New Morning After Pill Alzheimer’s Disease Pfizer’s Pipeline Opportunity for China and India The U.S. drug industry ended 2009 with plans to eliminate a record 69,100 jobs. The toll is up 60% from 43,000 in 2008 and more than quadruple the 15,600 in 2004, according to outplacement outfit and layoff tracker Challenger, Gray & Christmas. The pre-eminence of a nation is derived not only from its GDP growth rate, foreign trade and military modernization; but also from its intellectual and technological strength and its ability to constantly innovate and evolve. Although the US will continue to be a pre-eminent power of the world, with loss of incentives to research in the US, it is fast losing one of the fundamentals of its preeminence. Top Pharma Layoffs in 2009 http://industry.bnet.com/pharma/10005841/top-pharma-layoffs-of-2009-pfizers-on-first-mercks-on-second-whos-on-third/?tag=content;selector-perfector New Jobs A proposed 170-acre research park, expected to be the engine of a redeveloped Fort McPherson, could generate up to 7,000 jobs and lure Big Pharma to southwest Atlanta. The research park is part of an ambitious mixed-used makeover of the more than century-old army base that could generate up to 15,000 jobs. Next month, the McPherson Implementing Local Redevelopment Authority will accept proposals to help “fine tune” its plan to revitalize the 488-acre base, scheduled to close next year. The authority is expected to negotiate the transfer terms of the Army-controlled land by this fall. The park, anchored by an institute that could focus on vaccine development, regenerative medicine, cardiovascular research, and neuroscience, would be marketed more as a research and development center than for large-scale manufacturing. Moving the project from blueprint to bricks and mortar, however, will require significant public-private investment and collaboration between multiple stakeholders. The research park, alone, could cost up to $168 million to develop. New Morning After Pill Levonorgestrel, the most widely used emergency contraceptive pill, is only effective if women take it within three days of having sex. It is sold under various brand names including Levonelle and Plan B, and is available in more than 140 countries, including the United States, Canada and many countries in western Europe. In nearly 50 of those countries women can get it without a prescription. International researchers compared Plan B to a new drug ulipristal acetate, sold as ellaOne in Europe only with a doctor's prescription and found it to be more effective than the most widely used drug at preventing pregnancies in women who had unprotected sex and also works longer, for up to five days, according to a report published in the British medical journal, Lancet. The drug is not legally on the market elsewhere. Plan B contains synthetic progesterone and mimics how the natural hormone works, interfering with ovulation in the early stages of the egg's development. In contrast, ellaOne delays ovulation until the egg is released from the ovary. ellaOne costs about three times the price of Plan B. http://www.youtube.com/watch?v=AKl7A1tsbxc&NR=1 Alzheimer’s Disease Age is the biggest risk factor for Alzheimer's disease and other forms of dementia that affect about one in eight people 65 or older. Scientists have long noticed that some of the same triggers for heart disease -- high blood pressure, obesity, diabetes -- seem to increase the risk of dementia, too. But for years, they thought that link was with "vascular dementia," memory problems usually linked to small strokes, and not the scarier classic Alzheimer's disease. Factors like hypertension -- blood pressure readings of 140 over 90 or higher -- that weaken arteries also seem to spur Alzheimer's disease-like processes. One suspect is scarring known as white matter lesions. White matter acts as the brain's telephone network, a system of axons, or nerve fibers, that allow brain cells to communicate with each other. Even slightly elevated blood pressure can damage the tiny blood vessels that nourish white matter, interrupting those signals. Pfizer’s Pipeline Pfizer Inc. provided an update to its pipeline for the first time since the close of the acquisition of Wyeth in October, 2009. The new development pipeline, composed of assets from both legacy companies, includes 133 programs from phase 1 through registration, and shows growth and increased diversity in each of the areas where the company invests in research and development. Pfizer has identified six “Invest to Win” areas of research where there exist significant opportunities for innovation and market leadership: oncology; pain; inflammation; Alzheimer’s disease; psychoses; and diabetes. The new pipeline demonstrates focused investment in these areas of significant unmet medical need as well as growth in the critical technologies of vaccines and biologics. Following the acquisition of Wyeth, the combined company pipeline had 600 projects ranging from discovery through registration. The new prioritized portfolio contains about 500 projects across a broad range of diseases, with a focus on the “Invest to Win” areas, as well as vaccines and biologics. Approximately 70% of Pfizer’s research projects and 75% of the late-stage portfolio are focused on these areas. The growth in vaccines and biologics is reflective of Pfizer’s goal of becoming a top-tier biotherapeutics company by 2015. The company’s pipeline now includes a total of 6 vaccines and 27 biologics in development, up from 1 vaccine and 16 biologics at the last pipeline update in March 2009. Pfizer’s portfolio now includes: * 30 compounds in development for various oncology indications, including PF-02341066, a c-MET-ALK inhibitor in Phase 3 for the treatment of non-small cell lung cancer, and axitinib, a VEGF inhibitor in Phase 2 for lung, gastrointestinal, thyroid, and breast cancer and Phase 3 studies for renal cell carcinoma (RCC). Pfizer has two pan-HER/erbB targeted agents in Phase 3 studies, including PF-00299804 for non-small cell lung cancer and Neratinib for metastatic breast cancer. In addition, Pfizer has therapeutic targets in hematology with compounds in Phase 3 development, such as bosutinib, for the treatment of chronic myelogenous leukemia (CML), in addition to compounds in earlier development, such as inotuzumab ozogamicin for the treatment of Non-Hodgkin’s Lymphoma. Last month, a supplemental new drug application (sNDA) seeking FDA approval for Sutent for the treatment of pancreatic neuroendocrine tumors was filed. Sutent is an oral multi-kinase inhibitor approved for the treatment of advanced / metastatic renal cell carcinoma (RCC) and the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. * 10 compounds in development for Alzheimer’s disease, representing a range of mechanisms Pfizer is evaluating for the treatment of this illness. These include Latrepirdine (Dimebon), being developed by Pfizer and Medivation, and bapineuzumab, being developed by Pfizer and Janssen, both in Phase 3 development for the treatment of Alzheimer’s disease. * 8 compounds in development for pain, including tanezumab, a novel injectable biotherapeutic compound which targets nerve growth factor. The Phase 3 program studying tanezumab in osteoarthritis initiated in November, 2008, with more than 5,000 patients planned to be treated with this potential new medicine. * 11 compounds in development for inflammation, including tasocitinib (CP-690,550), Pfizer's JAK-3 inhibitor in development for the treatment of rheumatoid arthritis (RA). Pfizer initiated a global Phase 3 clinical program in RA for tasocitinib (CP-690,550) in February 2009, with five Phase 3 studies ongoing. * 6 vaccines and 27 biologics in the development pipeline, including Prevnar 13, a vaccine designed to prevent pneumococcal disease in infants and young children. Prevnar 13 has been approved for infants and young children in 34 countries, including in the EU and Canada, and is under regulatory review in many other countries, including the U.S. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010. By the end of 2009, Pfizer as a stand-alone company met three late-stage development commitments made to investors in March 2008. It met a commitment to initiate 10-12 Phase 3 starts between March, 2008 and March, 2009, and it met commitments to initiate 15 Phase 3 starts in the 2008-2009 period and to have 24-28 new molecular entities and new indications in the Phase 3 pipeline by the end of 2009. The new combined company pipeline has 34 new molecular entities and new indications in Phase 3. Pfizer also announced that it has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Lyrica for the adjunctive treatment of generalized anxiety disorder (GAD). In November, 2009, Pfizer announced that it would reduce its global R&D square footage by 35 percent. Consequently, R&D activities will be conducted at five main sites and nine specialized units around the world as compared with 20 R&D sites upon closing the acquisition of Wyeth on October 15, 2009. Detailed information about Pfizer’s pipeline is available at http://www.pfizer.com/pipeline. Indian Biotech Positive triggers would propel India's biotech sector to become a ten billion dollars industry by 2015, CMD of Biocon Ltd Kiran Mazumdar-Shaw said. The BT industry veteran expects the industry to grow to five billion dollars by next year. India's BT industry is at an inflexion point, has attained "critical mass" and created a platform that allows it to leapfrog and delivery exponential growth, she said. "India is today becoming the vaccine capital of the world. Bio-manufacturing offers a huge potential and already there are indications that many global contract manufacturers announced they will be shifting their base from Europe to Asia. I think India will be one of the beneficiaries of that particular strategy", Mazumdar-Shaw said. Clinical trials, agri-biotech and bio-fuels are becoming big opportunities for India, she said. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, CNN, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. 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