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Auxilium Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2010 Financial Results, Guidance for 2011
Date:2/10/2011

fitability for the Company."

2010 and Recent Highlights: XIAFLEX:

  • Worldwide revenues for XIAFLEX were $18.4 million for the year ending December 31, 2010 versus $3.6 million in 2009.
  • Sales of XIAFLEX in the U.S. were $14.1 million in 2010, representing approximately 4,500 vials of XIAFLEX.  The product was launched in late March 2010.
  • Beginning January 1, 2011, a new XIAFLEX-specific J-code (J0775) was available for use in the U.S. to identify XIAFLEX for obtaining reimbursement from Medicare, Medicaid and commercial health plans.
  • On December 16, 2010, Auxilium's EU partner, Pfizer Inc. (Pfizer), received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending European Union (EU) approval for Xiapex (EU tradename for collagenase clostridium histolyticum) as treatment for Dupuytren's contracture in adult patients with a palpable cord.  Pfizer expects EMA approval of Xiapex in the first quarter of 2011.
  • On December 6, 2010, The Journal of Hand Surgery published in its December online edition the Company's pivotal CORD II phase III clinical trial of XIAFLEX. The CORD II study is the second pivotal clinical trial examining the treatment of Dupuytren's contracture with XIAFLEX.
  • On October 12, 2010, the U.S. Patent and Trademark Office issued U.S. Patent No. 7,811,560 covering XIAFLEX with independent claims that recite a drug product, a process for producing the drug product, and pharmaceutical formulations comprising the drug product.  As a result, the Company expects XIAFLEX to have patent protection through 2028.
  • On October 11, 2010, the Company announced that the first subject had been dosed with XIAFLEX in the largest ever global phase III program for the treatment of Peyronie's disease, a devastating disease that is estimated to affect approximately 5% of adult men.(i) Auxilium anticipates completing enrol
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  • SOURCE Auxilium Pharmaceuticals, Inc.
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