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Contents
Pharma Giants to Collaborate Teva Gobbles up Barr FDA in India, China, Europe and Latin America FDA Exempts Phase I Drugs From GMPs Roche on Buying Spree Pharma Giants to Collaborate Three of the biggest pharma companies on the planet are joining forces to back an unusual venture aimed at developing "breakthrough" discovery technology that can reduce the frequency of trial failures and save them huge amounts of money. Eli Lilly, Merck and Pfizer--which often compete on new therapies--are joining forces with PureTech Ventures to provide $39 million to finance the launch of Enlight Biosciences. Enlight in turn plans to spin off new companies if the technology looks promising enough. Some of the new technologies the collaboration will explore include finding ways to deliver drugs across the blood-brain barrier and new biomarkers. "Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical companies are falling behind," Enlight co-founder Raju Kucherlapati, a genetics professor at Harvard Medical School, told the Wall Street Journal. "The biopharmaceutical industry has a great need for innovative enabling technologies that will catalyze fundamental transformation of the drug discovery and development process. A collaborative entrepreneurial initiative such as Enlight that is dedicated to such technological innovation in R&D meets that need in an ideal way. We are excited about our partnership with Enlight and its team of world-renowned scientists," said Dr. Steven Paul, the executive vice president, science and technology, at Eli Lilly. http://online.wsj.com/article/SB121565639890841655.html?mod=2_1566_topbox Teva Gobbles up Barr Teva Pharmaceutical Industries, the Israeli company and the world's largest generic drug company, announced that it has agreed to acquire rival Barr Pharmaceuticals Inc. for $7.46 billion, in a move that would give a significant boost to its leadership in the U.S. market and strengthen its position in Europe. The total deal value is $7.46 billion plus about $1.5 billion of net debt, the two companies said in a statement. Under the terms of the agreement, Teva will pay $39.90 in cash and 0.6272 of an American Depositary Receipt for each Barr common share. Teva's purchase means that a huge amount of shekels will have to be exchanged to dollars, putting upward pressure on the rate. The result is the opposite of the purchase of an Israeli firm for $4.4 billion by American investor Warren Buffet more than two years ago. The exchange rate was as low as 3.20 shekels to the dollar a week ago. FDA in India, China, Europe and Latin America Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications. Bush administration officials said the agreement will allow regulators to coordinate their inspections and share information, thereby covering a wider territory and more foreign facilities. The globalization of pharmaceuticals took on new focus last spring after the blood thinner heparin — made with active ingredients from a Chinese facility — was linked to dozens of deaths and hundreds of severe allergic reactions in this country. The drug was recalled by Baxter International and the U.S. blocked imports from the Chinese company. The Food and Drug Administration found the heparin was contaminated with a nutritional supplement that costs less, but mimics the real drug in routine tests for potency, and thus was not detected. Investigators suspected deliberate contamination. The FDA had not previously inspected the Chinese facility because of a mix-up. And neither had Chinese drug safety regulators, because the plant was registered as a chemical factory. The FDA expects to soon open offices in three Chinese cities — Beijing, Shanghai and Guangzhou. Thirteen employees would be assigned to work there. The FDA wants to set up operations in India this year or in early 2009 to improve oversight of food, medicines, medical devices and animal feed imported into the U.S., Deputy Commissioner Murray Lumpkin announced. The agency is preparing to open offices in China, India, Europe and Latin America by the end of 2009. The agency also intends to set up offices in the Middle East. The Senate Appropriations Committee unanimously passed an appropriations markup measure, providing the FDA with a $2.04 billion fiscal 2009 budget. Also, the FDA announced launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioner’s Fellowship Program will provide participants with advanced training in the scientific analysis involved in the safety and regulatory decisions unique to the agency’s mission. FDA Exempts Phase I Drugs From GMPs More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the FDA is issuing a final rule to do just that. The new rule, which amends the GMP regulation with the exact same language as the withdrawn rule, was published in Tuesday’s Federal Register. Slated to take effect Sept. 15, it will apply to small-molecule drugs and biologics, including vaccines and gene therapy products. Roche on Buying Spree Roche, a world-leading healthcare company, announced that it has proposed to acquire the outstanding publicly held interest in Genentech, a leading biotechnology company, for US$89.00 per share in cash, or a total payment of approximately US$43.7 billion to equity holders of Genentech other than Roche. Roche acquired a majority in Genentech in 1990 and currently owns 55.9% of all outstanding shares. The combined entity will be the seventh largest U.S. pharmaceuticals company in terms of market share. It will generate more than US$15 billion in annual revenues and will employ around 17,500 pharma employees in the U.S. alone, including a combined sales force of approximately 3,000 people. Including diagnostics, the Roche Group will employ around 25,000 people in the U.S. By reducing complexity and eliminating duplicative functions in areas like development, manufacturing, corporate administration and support functions, the combination will result in lean and efficient structure. Market and regulatory forces are driving biotech and Big Pharma closer together. For 30 years the biotech industry has led a free and unobstructed life. Companies that develop biologic remedies such as Genentech, Amgen, Gilead Sciences and Genzyme have been free to flourish without many of the regulatory and competitive pressures that giant pharmaceutical companies face. That relative freedom allowed global biotech sales to grow 12.5 percent (to $75 billion last year), compared to a 6.4 percent rate of sales growth for Big Pharma drugs. Soon, there are going to be heavier burdens placed on biotech over the next five or so. Biotechs are likely to experience greater competition in disease areas like cancer from big drug companies that have bought smaller biotechs or developed alliances with them. Meanwhile, the regulatory picture for biotechs is radically changing. As drugs from the first wave of biotech approvals two decades ago are approaching patent expiration, patients, doctors and insurers are demanding inexpensive alternatives to biotech drugs. Congress and the Food and Drug Administration are under pressure to fashion a new regulatory pathway for federal review and approval of generic biotech drugs, or "biosimilars." In June 2007, the Senate health committee passed the "Biologics Price Competition and Innovation Act," a law that seeks to allow biosimilars into the marketplace. Also, Roche and Mirus Bio Corporation announced that they have entered into a definitive agreement under which Roche will acquire Mirus Bio Corporation, a privately-owned US company based in Madison, Wisconsin, that focuses on the discovery and development of innovative nucleic acid based technologies, including a proprietary RNAi (Ribonucleic Acid interference) delivery platform. RNAi, a mechanism that the body uses to 'silence' certain genes, represents a potential whole new class of therapeutics for difficult to treat diseases. The major challenge of this promising technology has so far been the transport of RNAi molecules into the target cell. Mirus' delivery platform provides an innovative way of effectively getting RNAi therapeutics to specific disease targets. Roche and ARIUS Research Inc. announced that the two companies have signed a definitive agreement for Roche to acquire ARIUS in an all-cash transaction at a price of approximately C$191 million. ARIUS is the developer of a proprietary antibody platform called FunctionFIRST(TM), which rapidly identifies and selects antibodies based on their functional ability to affect disease before progressing into clinical development. The FunctionFIRST(TM) platform will allow Roche to further strengthen its developmental portfolio, initially within the areas of oncology and inflammatory diseases where this new technique offers potentially broad therapeutic applications. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, 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. Specialist advice should be sought about your specific circumstances. |
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