安进

Fulfilling Amgen's mission to be the world leader in developing and delivering cost-effective therapeutics based on advances in cellular and molecular biology depends upon the company's ability to make continued progress in unlocking the power of cellular and molecular biology to develop products that satisfy the unmet medical needs of patients worldwide. Amgen, Inc. stands out in the biotechnology industry as one of the only businesses to transform itself from a drug development company into a pharmaceutical manufacturer while simultaneously maintaining steady sales. The largest independent biotechnology company in the United States, Amgen owes its transformation mostly to two gene-spliced drugs, Neupogen and Epogen. The company continues to develop human bio-pharmaceutical products using proprietary recombinant DNA technology. Because the worldwide market for patients with kidney failure was about $350 million a year in the mid-1980s, and because there were then fewer than 200,000 kidney-dialysis patients in the United States, Amgen's EPO was accorded "orphan drug" status by the FDA, an exclusive seven-year marketing rights privilege. However, many argued that EPO was not just a drug for those suffering kidney failure; its applications for anemia, a common side effect of certain treatments for cancer, arthritis, and AIDS, were unlimited. The drug could also be used to reduce the need for blood transfusions during surgery. With those uses in mind, in 1985 Amgen sold Johnson & Johnson the right to market EPO for treatment of anemia in the United States and for all uses in Europe. The previous year, Amgen had formed a joint venture with Kirin Brewery Company, Ltd. of Japan, according Kirin the right to manufacture and market EPO in Japan. Amgen, with rights to the U.S. dialysis market, began building an EPO manufacturing facility near its headquarters even before the company was granted its first patent for its recombinant human erythropoietin, named Epogen. Two days after receiving the patent in October 1987, Amgen filed with the FDA. As the first company to isolate and patent the human gene responsible for making EPO and to reproduce the drug in large quantities by transplanting the isolated gene into the ovarian cells of hamsters, Amgen had patent rights to genetically engineered EPO. One of Amgen's competitors, Genetics Institute (GI), was the first to isolate a purified strain of the protein and had received a patent on natural, highly purified EPO. The two companies now sued each other for patent infringement in an acrimonious battle due to its high stakes. GI had licensed its patents to Chugai Pharmaceutical Company, which planned to market EPO in the United States through Upjohn Company. Amgen subsequently asked the International Trade Commission (ITC) to block imports of Chugai's EPO, but an ITC judge declined to do so in January 1989. These legal tangles caused further delay in FDA approval of Epogen, which allowed competitors to pull ahead in their efforts to market the drug and meant financial losses for Amgen, which was poised to begin immediate shipments to patients with end-stage renal, or kidney, disease. In March 1989, a federal judge ruled that Ortho and Amgen had to submit a joint application for FDA approval of EPO, suggesting that cross-licensing might be a solution. Meanwhile, GI was nearing the finish line in its own labs. On June 1, 1989, the FDA approved Amgen's EPO for treatment of anemia in kidney dialysis patients. The next day Amgen shipped its first batch of the drug to UCLA Medical Center. By the end of June, it had sold nearly $17 million worth of the drug--its first product after nine years in business. Legal wrangles continued, but Amgen had the market to itself. GI's version of EPO awaited FDA approval. Around this time, CEO Rathmann passed his title to longtime CFO Gordon M. Binder, the author of Amgen's deal with Kirin Brewery. Meanwhile, expectations were great for Amgen's new drug,