* 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 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 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
Auxilium is also testing Xiaflex as a treatment for frozen
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.