Amgen Says Court Proceedings Over Epogen Will Resume in April

Amgen Inc. said court proceedings will resume in April 2000 in a patent dispute with fledgling biotech company Transkaryotic Therapies Inc. over Amgen’s top-selling anemia drug erythropoietin.

The battle pits Amgen, the world’s No. 1 biotechnology company based in Thousand Oaks, against Transkaryotic, a money-losing biotech company based in Cambridge, Mass., and its development partner, No. 1 German drugmaker Hoechst AG.

The trial is to decide whether Transkaryotic and Hoechst can sell an anemia drug that would rival Amgen’s erythropoietin, or EPO.

The drug, which is sold by Amgen under the brand name Epogen and by Johnson & Johnson as Procrit, has annual sales that analysts estimate to be about $4 billion, making it the world’s best-selling bioengineered treatment.

Both sides said they expect to prevail in the high-profile proceeding, which has cast a cloud over Amgen’s stock. Amgen shares fell 7% June 10 after Transkaryotic last month said it would reopen the long-running dispute over Amgen’s top-selling product, whose sales accounted for more than half of the company’s 1998 revenue.

Amgen also announced Monday that U.S. regulators could require it to conduct large-scale tests on an experimental arthritis drug, correcting a July 12 press release.

The company said it corrected the release at the request of the U.S. Food and Drug Administration to make it clear that the FDA has the right to ask it to conduct another round of tests before it accepts Amgen’s application to market its IL-1ra drug as a treatment for rheumatoid arthritis.

Amgen shares soared 9.1% July 13 after the company reported better-than-forecast second-quarter earnings and surprised investors by saying it plans to file for approval of the arthritis drug by year-end, about two years faster than expected.