US FDA rejects Amgen/Praecis cancer drug Plenaxis

13 June 2001

Amgen and Praecis Pharmaceuticals' application for theirgonadotropin-releasing hormone antagonist Plenaxis (abarelix) is "inadequate for approval" for the treatment of prostate cancer, according to the US Food and Drug Administration. Praecis shares' plummeted 37% to $14.01 and Amgen's stock fell 3.3% to $64.53 on June 12, on the unexpected bad news for Plenaxis, for which peak annual sales of around $300 million have been forecast.

The companies had submitted a New Drug Application to the agency for Plenaxis in December 2000, and the FDA then gave it priority six-month review status. Earlier this month, the companies had presented positive Phase II trial data on the drug at the annual meeting of the American Urological Association concerning its ability to suppress serum prostate antigen levels and testosterone levels compared with standard hormonal therapy (Marketletter June 11).

The companies said that they were seeking a meeting with the FDA promptly, in an effort to clarify the various deficiencies with Plenaxis which were cited in the agency's letter, and to discuss what further steps need to be taken before the application might be approved.

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