Auxilium Pharmaceuticals Inc. (AUXL) continues to anxiously await a Food and Drug Administration decision on Xiaflex in treating a hand disorder, but the company said it remains confident the drug will get approved and is prepared for its launch.

The Malvern, Pa., biotech has been waiting for a decision since the fall, after an FDA panel of outside experts recommended approval of the enzyme, which breaks down collagen. It treats Dupuytren's contracture, the buildup of collagen in the hands that can prevent extension of the fingers.

"It is right around the corner," Auxilium President and Chief Executive Armando Anido said of the FDA's decision in an interview at the J.P. Morgan Healthcare Conference in San Francisco Wednesday.

Auxilium will sell the drug itself in the U.S., and its overseas partner Pfizer Inc. (PFE) should be filing for European approval soon. Anido said the company has had an ongoing dialogue with the FDA to answer any questions about the application.

"It is hard to believe there are many more questions they can ask," Anido said, stressing that he doesn't see any "red flags" from the agency that it will seek more data or delay a decision.

To be sure, regulatory decisions can be tricky and the FDA has unleashed surprises in the past, even after a panel recommended a drug's approval.

In the meantime, Auxilium is ready for the launch. It has 75 to 100 sales representatives with contingent hiring offers, and sales managers already are busy profiling physicians and territories so the new team can hit the ground running.

The company has been building inventory of Xiaflex and plans to sell the drug within 60 days of approval.

Collins Stewart recently projected Xiaflex sales for Dupuytren's contracture of $58.7 million in 2010, reaching $353 million in 2013.

The initial sales trajectory of the drug is hard to gauge, Anido said, noting that some doctors are withholding patients from surgery in anticipation of the drug, while others are more hesitant and might be slower to adopt the new treatment.

Part of Auxilium's strategy to reach those slow adopters is connecting directly with patients through an Internet strategy so that they can become aware of the treatment and seek it out themselves.

The cost of the drug will likely be comparable to surgery, which averages about $5,000. Since the typical patient gets three doses, the price should be $1,600 to $1,700 per dose, although that could change, Anido said.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com