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New
Generation of Vaccines
Stem Cells for Breast Augmentation Drug Development Eli Lilly to Outsource around the World Chemist to Lead Lilly Sanofi-Aventis in India Capsule v. Tablet New Generation of Vaccines Researchers at Novartis have been using gene-mapping tools to develop new vaccines. Mapping the genes in bacterium that cause meningitis B fostered a development program for a new vaccine that has produced some convincing early data. Up to 90 percent of the 150 babies inoculated with the vaccine developed a strong level of defense against three strains of meningitis B. Geneticist Craig Venter, who helped crack the genetics of meningitis, calls the advance "incredibly exciting," adding that this could be a model approach that others in the vaccine business can follow as well. Intercell and Merck, meanwhile, have been developing vaccines for staph infections that have been derived from their own gene-mapping projects. And GSK has early-stage programs for vaccines covering streptococcus and the bacterium that causes meningitis B. With the growing pressure to produce new therapies to replace the blockbusters losing patent protection, big pharma is forced to play a leading role here. Stem Cells for Breast Augmentation For the first time, doctors have used stem cells to fix breast defects in women who have had cancerous lumps removed. The approach is still experimental, but holds promise for millions of women left with breasts that look very different from each other after cancer surgery. It also might be a way to augment healthy breasts without using artificial implants. It has been tested on about two dozen women in a study in Japan. Doctors say it has great potential. More than 100,000 women have lumps removed each year in the United States. These operations, lumpectomies, often are done instead of mastectomies, which take the whole breast. But they often leave deformities because as much as a third of a woman's breast may be removed. The implants sold today are for reconstructing breasts after mastectomies. They aren't designed to fix odd-shaped deformities from lumpectomies or radiation. Drug Development The global drugs development market is now undergoing dramatic change. As the pharma industry continues to experience rising research costs, drug failures and low returns on investment, companies who are increasingly facing major patent expiries and scarcely populated late-stage pipelines have accelerated efforts to enhance the speed and efficiency of drug research. New concepts are emerging to revolutionize the traditional R&D paradigm by integrating drug discovery and development, areas with previously limited interaction. This change could open an outstanding window of opportunity for life sciences market in other countries. The big drug companies are restructuring their ethical drug development operations. The development of a new drug costs around $1 billion, but even with higher investment in R&D, not enough molecules are coming onto the market. A decade ago, drug companies spent $25 billion on the development of new molecules in North America alone, and by 2006 this figure had more than doubled to $55 billion. Sadly, this increase in expenditure didn't translate into increased number of drugs. The US Food and Drug Administration (FDA) approved 22 molecules in 2006, compared with 53 molecules in 1996. Because of this anomaly, the rate of growth in new small molecule drugs now stands at just 2% a year. At the same time, clinical trials have become more costly. Insurance providers and the large drug buyers are bringing pressure on companies to lower prices, while on the other hand, generics manufacturers are breathing down the big pharma's neck. These elements are driving the big companies to make small acquisitions, not just of later-stage companies, but also technology platforms. This enables them to keep own costly in-house R&D activity down to a minimum. The big drug companies will be looking, principally, to acquire the following types of companies: 1. Companies which have early-stage molecules (such as the potential million dollar deals between Israeli company QBI Enterprises and Pfizer, and the semi-Israeli Epix Pharmaceuticals, and Amgen, and GSK). Technology platforms for the production of therapeutic products (such as Protalix). 2. Proven drug development methodology, that will enable a drug's success to be predicted before clinical trials (such as NST-Neurosurvival Technologies). 3. Markers and genetic disease diagnosis methods for the customizing of individual treatment programs, and making the right choice of patients for trials. 4. Generic biological, or bio-similar drugs. The desire to replicate biotech drugs so as to circumvent patents (in instances where the patent is based on a chemical principle) is a top priority for leading generics companies. 5. The immunotherapy market. This field is growing by 11-14% a year. Preventative vaccines have always been a priority for classic drug companies, and now immunotherapy vaccines are as well. Eli Lilly to Outsource around the World Five years from now, Eli Lilly and Co. could look like a different company, with fewer employees and plants, as it shifts more of its scientific research, manufacturing, sales and administrative work from Indianapolis to outsiders around the world. Facing pressures that have rattled the pharmaceutical industry, the drug maker told analysts that it is transforming aggressively from a fully integrated pharmaceutical company into a "network structure" of outside contractors, service providers and others to further cut costs and improve productivity. The company already has cut 2,200 jobs here since 2004, or 15 percent of its work force, and now employs 12,000, mostly at its headquarters, laboratories and manufacturing operations Downtown. Lilly is responding to a major shift in the industry as drug makers face a wave of patent expirations, increasing pressure from insurers to control prices and slowing industry growth. Already, Lilly has outsourced 40 percent of its information technology, 20 percent of its manufacturing, nearly 20 percent of its U.S. sales force and the bulk of its employee services, such as cafeteria workers, janitors and guards. Overall, the company uses more than 80 contract-manufacturing organizations. It said it plans to shift more of its finance, human resources and technology functions to outsiders. More significantly, Lilly is pushing to shift up to half of the cost of its research and development, long considered a core mission, onto outside partners by 2010. In recent years, Lilly has formed partnerships with firms worldwide for basic chemistry, early-stage drug development and clinical trials. Other drug makers, from AstraZeneca to Johnson & Johnson, are slashing tens of thousands of jobs, according to Bernstein Research. Recently drug maker Bristol-Myers Squibb said it would wipe out 4,300 jobs, or 10 percent of its work force, and close more than half its manufacturing plants by 2010. Chemist to Lead Lilly Eli Lilly and Company announced that Sidney Taurel, chief executive officer and chairman of the board, will retire as CEO effective March 31, 2008. Taurel will remain chairman of the company's board of directors until December 31, 2008, at which time he will retire from the board and from the company. John C. Lechleiter, Ph.D., currently president and chief operating officer, will assume the role of president and chief executive officer as of April 1, 2008. Lechleiter joined Lilly in 1979 as a senior organic chemist in process research and development, and he became a head in that department in 1982. In 1984 he began serving as director of pharmaceutical product development for the Lilly Research Center (Erl Wood) in Windlesham, England, and he subsequently returned to the U.S. in 1986 as manager of research and development projects for Europe. In 1988, he became director of development projects management, and in 1989 assumed additional responsibility for pharmaceutical regulatory affairs, chemistry, manufacturing and control. In 1991 he was named executive director of pharmaceutical product development and became vice president in 1993. Lechleiter was appointed vice president of regulatory affairs in 1994, vice president of Lilly Research Laboratories in 1996, and senior vice president of pharmaceutical products in 1998. In 2001 he became executive vice president for pharmaceutical products and corporate development, and then became executive vice president of pharmaceutical operations in early 2004. Sanofi-Aventis in India French pharmaceutical company Sanofi-Aventis SA had opened its first Asian pharmaceutical development center in Goa, another sign of increasing interest in India from global drugmakers. Sanofi spent about 1 billion rupees ($25 million) on the center, its single largest investment in India, it said in a statement. Sanofi's first Asian hub for analytical and pharmaceutical formulation development, is located close to its existing manufacturing facility in the coastal state of Goa, and will have the capacity to develop up to 12 pharmaceutical compounds a year. Capsule v. Tablet The difference between a tablet and a capsule might not seem big, if you are not a vegetarian. But, if you were a vegan or vegetarian, obvious preference would be a tablet as capsule contains gelatin made from bones of animals. This preference of a few vegetarians may not make a dent into capsule sales. But it could result in hundreds of millions of dollars in lost sales, if the tablet is also generic! Wyeth, the Madison, N.J.-based Company, makes the best-selling antidepressant in the world, Effexor, with sales on pace to exceed $3.7 billion this year. The most common version is an extended-release capsule, Effexor XR. Until recently, it seemed Wyeth would be the exclusive seller of extended-release Effexor in the United States through July 2010, thanks to its resolution of patent litigation in 2005. But now Wyeth's market exclusivity is being threatened. Sun Pharmaceutical Industries Ltd., a generics manufacturer in India, has applied for U.S. Food and Drug Administration approval to sell the drug with the same active ingredient as Effexor XR, but with an important difference. It's an extended-release tablet, not a capsule. FDA approval of what is likely to be a lower-priced drug from Sun might come when patent protection for Effexor's active ingredient, venlafaxine, runs out in June 2008. Patent protection for the capsule formulation expires later in July 2010. Sun's different formulation of tablet should allow it to circumvent Wyeth's patent rights on capsule without any infringement. 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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