UPDATE 2-Auxilium penile curvature drug meets study goal

Mon Jun 4, 2012 10:40am EDT

* Says drug meets main goal of 2 late-stage trials

* To apply for marketing approval by 2012 end

* Says drug was well tolerated

June 4 (Reuters) - Auxilium Pharmaceuticals Inc said its drug to treat penile curvature fared better than a placebo in late-stage studies, sending its shares up as much as 12 percent on Monday.

The drug, Xiaflex, is already marketed as a treatment for Dupuytren's Contracture or the tightening of hand muscles from the accumulation of a type of protein.

The drug reduced curvature of the penis by more than 30 percent in two late-stage trials on men suffering from Peyronie's Disease.

Peyronie's Disease is caused by the accumulation of the protein collagen. The company said between 65,000 and 120,000 Peyronie's patients are diagnosed every year in the U.S., based on historical data.

Given that the primary endpoint of the study was met, Xiaflex should get approved to treat Peyronie's Disease, RBC Capital Markets analyst Michael Yee said in a note.

"We think the longer-term U.S. market is probably $100 million plus, as the market would grow from the 5,000 to 6,000 patients currently receiving injections/surgery," Yee added and raised his price target on the stock to $28 from $26.

The specialty pharmaceutical company said the drug was well tolerated in the study, and it plans to file for marketing approval of the drug by the end of the year.

The drug is marketed in Europe for the hand-disease by partner Pfizer Inc.

According to the deal signed in 2008, Pfizer can negotiate for exclusive rights to market all Xiaflex pipeline indications in Europe.

Auxilium is also testing Xiaflex as a treatment for frozen shoulder syndrome.

Shares of the Malvern, Pennsylvania-based company, which have lost about 6 percent of their value in the last three months, were trading up 7 percent at $20.22 on Monday on Nasdaq. They touched a high of $21.20 earlier in the session.

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