AMGEN RIVAL SUBMITS DRUG FOR APPROVAL TKT/AVENTIS IN COURT FIGHT.

Byline: Robert Monroe Staff Writer

THOUSAND OAKS - A rival of biotechnology superpower Amgen announced Thursday it is seeking regulatory approval of a drug similar to Amgen's flagship product.

TKT/Aventis hopes the U.S. Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products will approve its anemia drug Dynepo within a year. The company's ability to market the drug in the United States, however, is also dependent on the outcome of a civil trial brought against the company by Amgen, which claims TKT/Aventis is infringing on its patent for the drug Epogen.

TKT spokeswoman Justine Koenigsberg said the timing of the submission of Dynepo has nothing to do with the course of the lawsuit. The drug, known generically as erythropoietin, has simply passed through all necessary testing stages.

``Our development is proceeding in parallel with the litigation,'' she said. ``We've approached the next step.''

Amgen spokesman David Kaye did not return messages Thursday.

Analysts are split on what approval of Dynepo would mean to Amgen, where sales of Epogen bring in more than $1 billion annually. If TKT and its parent Aventis win the court case, it could begin selling Dynepo immediately after FDA approval is granted.

Dennis Harp, a Deutsche Bank Alex.Brown analyst who covers Amgen, said the Thousand Oaks company could already have a second-generation anemia drug, NESP, on the market by that time. The arrival of the new, improved drug could make FDA approval of Dynepo almost moot, he said. But there might be enough demand for the older drugs to make marketing Dynepo worthwhile for TKT/Aventis.

``Since (erythropoietin) is a multibillion-dollar product on a worldwide basis, for Aventis to spend $5 (million) to $10 million litigating makes good business sense on the off-chance they might win.''

But Tom Dietz, a Pacific Growth Equities analyst covering TKT/Aventis, believes NESP's reach will be limited, meaning Dynepo could cut into Epogen's market share.

``NESP is a product that to me has very little market share gain over Epogen,'' Dietz said.

In the lawsuit, Amgen contends that TKT/Aventis is infringing on Epogen's patent in the way the drug is formulated. A decision will not take place any sooner than next month.

Though TKT could be barred from selling Dynepo in the United States, the company could start selling it immediately in Europe regardless.

The submission for approval has substantial meaning for Cambridge, Mass.-based TKT. Its parent Aventis will pay it $3.5 million for reaching the milestone. Harp and Dietz's estimates of what TKT will get once Dynepo is approved vary with Harp anticipating an $8 million payout and Dietz estimating between $10 million and $20 million.

In trading Thursday, Amgen shares fell 13 cents a share to close at $70.19, on volume of 5.8 million shares on the Nasdaq exchange. TKT's shares rose to $30.25, up $1.13 on light volume of 110,000 shares on the Nasdaq exchange.