Auxilium Pharmaceuticals, Inc. and FCB I LLC (FCB) have received a notice from Watson Laboratories, Inc. that advises them of Watson's filing of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 USC Section 355(j) for testosterone gel. This Paragraph IV certification notice refers to FCB's nine US patents, covering Testim, 1 per cent testosterone gel, that are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the US Food and Drug Administration.

The referenced patents will expire between 2023 and 2025.

Auxilium and FCB are currently reviewing the details of this notice from Watson. Auxilium and FCB intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of their intellectual property rights and approved labelling.

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences.

FCB is an indirect, majority-owned subsidiary of Xstelos Holdings, Inc. ("Xstelos"), which is a wholly-owned subsidiary of Footstar, Inc. ("Footstar"). Footstar is a holding company that is winding down pursuant to an Amended Plan of Complete Dissolution and Liquidation ("Plan of Dissolution").