Auxilium Diabetes Drug Meets Endpoints, Yet Shares Slide (AUXL)

June 3, 2008 · Filed Under Diabetes · Comments Off 

Auxilium Pharmaceuticals Inc. (NASDAQ: AUXL) has reported that its experimental treatment for Dupuytren’s contracture met its primary endpoint in two Phase III studies.  Auxilium plans to submit an application for approval with the Food and Drug Administration in early 2009.

Dupuytren’s contracture is a diabetes-related condition where fingers and/or the palm of the hand thicken and shorten, causing fingers to curve inward.  The company noted that this could become the first new first-line treatment option for Dupuytren’s contracture.  The company results reported a 77.8% patient response in those treated with Xiaflex, which saw a reduction in joint curvature.  The placebo group saw a 14.3% improvement.

The company used 850 patients who were given Xiaflex injections in trials through May 2008.  Of the group, 7 serious adverse events possibly related to the drug have been reported and possible side effects were 3 tendon ruptures, 1 ligament injury, and 1 case of a serious blood clot. As far as how that compares to traditional treatments Auxilium noted that the rate of adverse events is comparable to that involved in surgery.

What is interesting is that if you read through the release it all sounds good.  But shares are down by close to 10% in pre-market trading.  Shares closed at $31.53 Monday and are down at $28.50 in pre-market trading on more than 400,000 shares at 8:20 AM EST.  The 52-week trading range is $14.37 to $36.14, and its market cap before today’s drop was about $1.3 Billion.

Jon Ogg
June 3, 2008