Auxilium Pharmaceuticals, Inc. Announces First Patients Dosed in XIAFLEX(TM)

U.S. Pivotal Phase III Study Enrollment in Australian Phase III Trial Also Has Commenced

reprinted from cnn.com news story

September 10, 2007: 02:18 PM EST

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) today announced that the first patients have been dosed in the Company's second U.S. phase III pivotal trial and the Australian phase III study for XIAFLEX(TM) for the treatment of Dupuytren's contracture, a disabling and recurring condition in which the joints in the hand contract, impairing patients' ability to straighten and move their fingers.

"We are tremendously excited about achieving these important development milestones for XIAFLEX," said Mr. Armando Anido, Chief Executive Officer and President of Auxilium. "XIAFLEX is a company-transforming product opportunity that has the potential to be the first, effective, non-surgical treatment for patients with Dupuytren's contracture."

The U.S. CORD (Collagenase Option for Reducing Dupuytren's) I study is a double-blind, randomized, placebo-controlled study of XIAFLEX involving approximately 216 patients at over 15 sites throughout the U.S. Patients in the study will be randomized on a 2:1 basis in favor of XIAFLEX treatment. To qualify for the study, patients must have at least 20 degrees of contracture. The primary endpoint of the study is to determine if XIAFLEX can reduce the contracture angle of the primary joint to within 0 to 5 degrees of normal after up to three injections of XIAFLEX.

Upon completion of the double-blind study, all patients will be enrolled in a separate open label extension study in which the patient will receive active drug if they were initially given placebo and/or they have the opportunity to have other affected joints treated. Data from the double-blind study and the open label extension study will form the basis of 12-month follow-up information to be used in the Biologics License Application ("BLA") for marketing approval of XIAFLEX submitted to the U.S. Food and Drug Administration ("FDA").

The Australian CORD II study is a double-blind, randomized, placebo-controlled study involving approximately 60 patients and follows a protocol similar to that of the U.S. pivotal phase III trial and its open label extension.

The Company expects that enrollment in the U.S. study will be completed by the end of this year, and that they will file a BLA with the FDA in early 2009.

About Dupuytren's Contracture

Dupuytren's contracture is a condition that involves contracture of joints in the hand that impairs patients' ability to straighten and move their fingers due to a thickening and shortening of the normal ligaments of the palm and fingers. As the disease progresses, functionality of the hand is severely impaired. The incidence of Dupuytren's contracture is highest in Caucasians, historically those of Northern European descent. Most cases of Dupuytren's contracture occur in patients older than 50 years.(1)

The most frequently affected joints associated with Dupuytren's contracture are the joints called the metacarpophalangeal joint, or MP joint, which is the joint closest to the palm of the hand and the proximal interphalangeal joint, or the PIP joint, which is the middle joint in the finger. The little finger and ring finger are most frequently involved.

(1) Badalamente, M. A., Hurst, L. C. et al., Collagen as a Clinical Target: Nonoperative Treatment of Dupuytren's Disease, The Journal of Hand Surgery, (2002;27A:788-798)