Auxilium Pharmaceutical Sees FDA Ruling On Hand Treatment Coming Soon
January 13 2010 - 5:46PM
Dow Jones News
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