MALVERN, PA and EXETER, NH--(Marketwire - October 24, 2008) - Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that they have received a notice from Upsher-Smith Laboratories, Inc. advising of the filing by Upsher-Smith Laboratories, Inc. of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for testosterone gel. This Paragraph IV certification notice refers to CPEX's U.S. Patent No. 7,320,968 ("the '968 Patent"), which covers Testim®, 1% testosterone gel. The Paragraph IV certification notice also states that Upsher-Smith Laboratories, Inc. does not believe that the product for which it is seeking approval infringes the '968 Patent. The '968 Patent is listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration, and will expire in January 2025.
