Amgen Wins Epogen Patent Suit in U.K.

Amgen Inc. on Wednesday won a patent infringement lawsuit in the United Kingdom over its blockbuster anti-anemia drug, Epogen. The ruling should ease the June debut of Amgen’s widely anticipated successor to Epogen.

The British High Court of Justice ruled that Transkaryotic Therapies Inc. and Roche Holdings Ltd. infringed on Amgen’s patent on erythropoietin, a protein that spurs production of red blood cells.

Transkaryotic said it will appeal. The Cambridge, Mass.-company also is appealing a similar ruling in U.S. District Court in Boston. Transkaryotic, which plans to market its drug in partnership with Aventis, claims it has developed an alternative method for producing the critical protein.

“We have strong grounds to appeal,” Transkaryotic President and Chief Executive Richard F. Seldon said, regarding the U.K. decision. “We look forward to a resolution of this case in mid-2002.”

Roche, which markets a version of the protein called NeoRecormon in Europe, is expected to appeal. A spokeswoman had no immediate comment.

Thousand Oaks-based Amgen doesn’t market Epogen in Europe. Johnson & Johnson sells it in Europe under the name Eprex pursuant to a licensing agreement with Amgen. But the ruling is significant to Amgen in two ways. In dealing a setback for J&J;’s competitors, it protects licensing revenue due Amgen from Eprex sales.

Beyond that, Amgen plans to launch in June a successor drug to Epogen in Europe, where final approval to market the drug, Aranesp, is expected soon. Wednesday’s court ruling potentially reduces the competition the drug will face in the $65-million U.K. market.

The drug is used to treat kidney dialysis patients whose ability to produce red blood cells is impaired. Analysts say the European market for anti-anemia drugs in the dialysis market is $800 million, with the U.K. representing an important piece of Aranesp’s anticipated debut.

Aranesp hasn’t yet been approved by the U.S. Food and Drug Administration, but analysts said no safety or efficacy issues have been raised about the drug and an OK is expected soon.

Amgen is testing Aranesp for use by cancer patients who suffer from anemia following chemotherapy. Analysts estimate that business accounts for half of J&J;’s $2.5 billion in sales from the drug, which it markets as Procrit for non-dialysis use in the United States.

Amgen shares closed at $51.87, up 36 cents, on Nasdaq. Transkaryotic closed at $15.10, down $3.30, also on Nasdaq.