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Auxilium Pharmaceuticals, Inc. Announces Second Quarter 2012 Financial Results
Date:7/31/2012

otice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.  The Company's licensee, Actelion Pharmaceuticals Ltd., expects to make XIAFLEX available to patients in Canada in the first half of 2013.
  • In June 2012, Auxilium announced positive top-line results from both phase III trials of XIAFLEX for the treatment of Peyronie's disease (assuming we receive FDA approval).  XIAFLEX demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo.
  • In May 2012, the Company and GlaxoSmithKline LLC ("GSK") announced that they entered into an agreement for the co-promotion of Testim, which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone.  GSK began promoting Testim using a sizeable established field sales force in the U.S. in mid-July 2012.
  • In May 2012, Auxilium and FCB I LLC ("FCB") announced that the United States Patent and Trademark Office issued U.S. Patent No. 8,178,518 covering, among other things, Testim 1% testosterone gel, marketed by Auxilium under license from FCB. This tenth Orange Book listed patent, which claims certain pharmaceutical compositions comprising testosterone, is expected to expire in April 2023.
  • In April 2012, Auxilium and FCB received a notice from Watson Laboratories, Inc. advising them of Watson's filing of an Abbreviated New Drug Application containing a Paragraph IV certification for testosterone gel.  In May 2012, Auxilium and FCB filed a lawsuit against Watson for infringement of Testim patents in the United States District Court for the District of New Jersey.
  • Second Quarter 2012 Financial Details 
    Total revenues for the three months ended June 30, 2012 were $78.2 million, an increase of 19% over the $65.9
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    SOURCE Auxilium Pharmaceuticals, Inc.
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