Auxilium Gets Special FDA Review for Drug

Wed, 04/29/2009 - 9:36am
MALVERN, Pa. (AP) — Auxilium Pharmaceuticals Inc. said late Tuesday the Food and Drug Administration granted it a key drug candidate priority review. The company is developing Xiaflex. The drug candidate is aimed at treating Dupuytren's contracture, which is a diabetes-related condition where fingers and the palm of the hand thicken and shorten, causing fingers to curve inward. The priority review means the a faster regulatory process for the drug candidate, with a decision expected by Aug. 28. as part of a six-month review. The standard review is 10 months. "We believe this designation emphasizes the significant need for a non-surgical treatment alternative for Dupuytren's contracture," said President and Chief Executive Armando Anido, in a statement late Tuesday. The company currently gets its revenue from sales of Testim, which treats the hormonal condition hypogonadism, a condition that impairs the function of the ovaries or testes. Roth Capital Partners analyst Scott R. Henry said the priority review designation had been expected and only changes the company's marketing timeline. The drug candidate already has special orphan drug status, which gives it 7 years of market exclusivity. "Therefore, priority review does not add time, but merely starts the clock earlier," Henry said in a note to investors. He reaffirmed a "Hold" rating.

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