Auxilium Stock Jumps As FDA Okays Xiaflex To Treat Peyronie's Disease - Update

(RTTNews) - Auxilium Pharmaceuticals Inc. (AUXL) said Friday that the U.S. Food and Drug Administration has approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first drug to treat men with bothersome curvature of the penis - a condition known as Peyronie's disease.

Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection.

Peyronie's disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

Xiaflex is a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum). Xiaflex was first approved by the FDA in 2010 for the treatment of Dupuytren's contracture, a progressive hand disease that can affect a person's ability to straighten and properly use their fingers.

The drug is believed to work for Peyronie's disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity.

A treatment course for Peyronie's disease consists of a maximum of four treatment cycles - each cycle consists of two Xiaflex injection procedures and one penile modeling procedure.

The safety and effectiveness of Xiaflex for the treatment of Peyronie's disease were established in two randomized double-blind, placebo-controlled studies in 832 men with Peyronie's disease. The drug significantly reduced penile curvature deformity and related bothersome effects.

When prescribed for the treatment of Peyronie's disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture and other serious penile injury.

The most common adverse reactions associated with use of Xiaflex for Peyronie's disease include penile hematoma, penile swelling and penile pain.

Meanwhile, BioSpecifics Technologies Corp. (BSTC), which developed Xiaflex, said it will receive low double-digit royalties based on a percent of sales.

Auxilium shares closed Friday at $21.64, up $2.31 or 11.95%, on a volume of 7.3 million shares on the Nasdaq.