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Tanox
Tanox was a biopharmaceutical company based in Houston, Texas. The company was founded by two biomedical research scientists, Nancy T. Chang and Tse Wen Chang in March 1986 with $250,000, which was a large part of their family savings at that time. Both Changs grew up and received college education in chemistry in National Tsing Hua University in Taiwan and obtained Ph.D. degrees from Harvard University. For postdoctoral training, Tse Wen shifted to immunology and did research with Herman N. Eisen at the Center for Cancer Research, M.I.T.. The two Changs successively became research managers and worked with a range of monoclonal antibody projects in Centocor, Inc. based in Malvern, Pennsylvania from 1981 to 1985.〔Twombly R. Couple Lead Quest for New Allergy Drug. ''The Scientist'' January 7, 1991. http://www.the-scientist.com/?articles.view/articleNo/11548/title/Couple-Lead-Quest-For-New-Allergy-Drug/.〕 The Changs were recruited by Baylor College of Medicine toward the end of 1985 and offered faculty positions in the Division of Molecular Virology. Soon after their arrival, they were encouraged by a high-ranking Baylor official and local business leaders to start a biotech venture in Houston. This was in a period of time when the economy of Houston was in slump as the result of the collapse of the oil industry.〔
The Changs rented a corner of about 2000 square feet in a large empty warehouse building on Stella Link Road, located four miles away from the Texas Medical Center, and built laboratories. In 1987, Tanox obtained a $4 million cash infusion from the legendary biotech venture capitalist and investor, Moshe Alafi,〔 who was a founding investor of Cetus, Amgen, Biogen, and a few other successful biotech companies.〔Goldhaber N and Steuart J. Biotech Industry Guru Moshe Alafi Wins Lifetime Achievement Award From UC Berkeley. Claremont Creek Alerts March 24, 2012. http://blog.claremontcreek.com/biotech-industry-guru-moshe-alafi-wins-lifetime-achievement-award-from-uc-berkeley/.〕 Nancy was the Chairman, President, and CEO of Tanox in its 21 year history, while Tse Wen was responsible for creating most of the company's proprietary technology and patents. Tanox's major technology was based on a series of inventions and a family of dominant patents, most notably those relating to the "anti-IgE therapy",〔The family of anti-IgE patents. http://www.google.com/patents/US5422258; http://www.google.com/patents/US5428133; http://www.google.com/patents/US5449760; http://www.google.com/patents/US5543144; http://www.google.com/patents/US5614611.〕 the "migis concept",〔The family of patents relating to the "migis" concept. http://www.google.com/patents/US5091313; http://www.google.com/patents/US5252467; http://www.google.com/patents/US5260416; http://www.google.com/patents/US5292867.〕 and the "anti-CεmX approach",〔investigational new drug" (IND) application approval, which is required for the first testing of a new substance in human subjects, for an anti-IgE antibody for the first time, from the U.S. Food and Drug Administration (FDA) in 1991. This was an important milestone in the development history of the anti-IgE program; Tanox scientists had anticipated major difficulty to receive IND approval for an anti-IgE antibody from the FDA, even though they had experimental data to show that CGP51901 would act differently from an ordinary anti-IgE antibody. Subsequently, Tanox/Ciba Geigy carried out a dose-escalating, double-blinded, placebo-controlled single-dose phase I clinical trial on 33 pollen-sensitive subjects with elevated serum IgE levels in Southampton, England. After resolving a few unexpected clinical findings, mainly the accumulating IgE and anti-IgE immune complexes, from the phase I trial, Ciba-Geigy and Tanox ran a successful phase II trial in 153 patients with severe seasonal allergic rhinitis toward mountain cedar pollens in three medical centers in Texas in 1994-1995. The positive clinical trial results, which showed increasing efficacy of CGP51901 over three different dosages (15, 30, or 60 mg in six bi-weekly doses) in improving nasal and ocular symptom scores, impressed the researchers and clinical investigators working on a similar anti-IgE program in Genentech.
In 1996, after a 3-year long lawsuit between Tanox and Genentech〔Thorpe H. Drug war (Small drug firm Tanox takes on Genentech over patent rights) ''Texas Monthly,'' April 1, 1995. http://business.highbeam.com/410545/article-1G1-16816180/drug-war〕 was settled out-of-court, Genentech made its first payment of $16 million to Tanox,〔Pollack A. Wrangling May Delay Peanut Allergy Drug. ''New York Times'' March 13, 2003. http://www.nytimes.com/2003/03/13/business/wrangling-may-delay-peanut-allergy-drug.html?pagewanted=all&src=pm〕 and Tanox, Novartis, and Genentech formed a tripartite partnership to develop the anti-IgE program.〔Tripartite Cooperation Agreement, by and between NOVARTIS PHARMA AG, GENENTECH, INC, AND TANOX, INC. http://www.sec.gov/Archives/edgar/data/1099414/000119312504083427/dex101.htm〕 A humanized anti-IgE antibody from Genentech, omalizumab, with identical key binding characteristics as CGP51901, was chosen by a joint program steering committee for further development, because it had a better developed manufacturing process.〔
Omalizumab, with the trade name Xolair, was approved by the U.S. Food and Drug Administration in 2003 for use in patients 12 years and older with moderate-to-severe allergic asthma. It was subsequently approved in the European Union and many other countries for patients 12 years and older with severe, persistent allergic asthma.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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