MALVERN, PA, Sep. 16, 2009 (Marketwire) --
MALVERN, PA -- (Marketwire) -- 09/16/09 -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a unanimous vote of 12 to 0 that XIAFLEX(TM) (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's contracture.
"We are very pleased with the Advisory Committee's unanimous recommendation, which supports our view that XIAFLEX has a favorable benefit to risk profile in the treatment of Dupuytren's contracture," said Armando Anido, Chief Executive Officer and President of Auxilium. "XIAFLEX has the potential to provide an important new non-surgical treatment option for patients with Dupuytren's contracture, a debilitating hand condition severely affecting patients' quality of life."
The Advisory Committee's recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Auxilium has submitted for XIAFLEX. The original target Prescription Drug User Fee (PDUFA) action date for the FDA's decision as to whether to grant marketing approval for XIAFLEX was August 28, 2009. The FDA has not updated the target PDUFA action date.
Conference Call
Auxilium will hold a conference call tomorrow, September 17 at 8:00 a.m. EDT, to discuss the outcome of today's FDA's Arthritis Advisory Committee meeting and other related topics. The conference call will be simultaneously web cast on Auxilium's web site and archived for future review until October 17, 2009.
Conference call details:
Date: Thursday, September 17, 2009
Time: 8:00 a.m. EDT
Dial-in (U.S.): 866-543-6407
Dial-in (International): 617-213-8898
Web cast: http://www.auxilium.com
Passcode: Auxilium
To access an audio replay of the call:
Access number (U.S.): 888-286-8010
Access number (International): 617-801-6888
Replay Passcode #: 99930573
About Dupuytren's Contracture
Dupuytren's contracture is a condition that affects the connective tissue that lies beneath the skin in the palm. The disease is progressive in nature. Typically, nodules develop in the palm as collagen deposits accumulate. As the disease progresses, the collagen deposits form a cord that stretches from the palm of the hand to the base of the finger. Once this cord develops, the patient's fingers contract and the function of the hand is impaired. Currently, surgery is the only effective treatment.
