Amgen, the Thousand Oaks biotechnology firm, is on the verge of getting approval to market its first drug for public use. The Committee for Proprietary Medicinal Products, the European equivalent of the U.S. Food and Drug Administration, has recommended that Amgen's new anti-anemia drug, erythropoietin (EPO), be made available for sale in the 12 European countries in the Common Market.
The committee issued its recommendation on June 21. Each member country has 60 days to decide whether to approve the sale of the drug. Philip Whitcome, Amgen's director of strategic planning, said he expected the approvals to start coming in soon and for the first shipments of EPO to be made in the next few months.
Johnson & Johnson has acquired the European rights to market EPO, although Amgen will receive a royalty on the sale of the drug.
In clinical tests in the United States and overseas, EPO has alleviated chronic anemia in patients suffering from kidney disease who must undergo frequent blood transfusions. When patients were given EPO, it triggered the production of red blood cells enabling patients to recover much of their energy without needing transfusions, according to the tests. Amgen's scientists and financial analysts also believe that EPO may help patients undergoing chemotherapy or suffering from rheumatoid arthritis.
Amgen has filed an application with the FDA to market EPO in the United States. Financial analysts have said they expect the FDA to approve EPO for sale by December. Analyst Denise Gilbert of Montgomery Securities in San Francisco said the European approval of EPO increases the probability that the FDA will approve the drug for sale. "The fact that it was approved with no particular problems suggests the data is fairly clean," she said.
Amgen has retained the rights to market EPO in the United States and is well ahead of rival biotechnology companies in the race to market EPO.
The worldwide annual market for EPO may be as high as $400 million by the early 1990s, according to financial analysts.
In biotechnology, scientists splice genes and reassemble them to produce large quantities of rare cells so that they can be used in drug form.
Amgen, which was started in 1980 by a small group of entrepreneurs and scientists, last year reported $53 million in sales and a $1.7 million profit. But the company has essentially been a research and development enterprise to date, and most of its sales figures represent payments to Amgen by its better-financed research partners, including Japan's Kirin, Abbott Laboratories and Johnson & Johnson.
Because Amgen officials expect to win FDA approval to sell EPO, and in anticipation of boosting production of the drug, the company recently bought manufacturing space that would enable it to double its size.