Warner Chilcott Announces Receipt of FDA Response to Citizen Petition

Warner Chilcott Limited (Nasdaq: WCRX) announced yesterday that it has received the FDA’s response to its citizen petition requesting that the FDA impose a 30-month stay of approval on Abbreviated New Drug Applications (“ANDAs”) referencing DORYX 100 and 75 mg delayed release tablets that were filed prior to the listing of the DORYX patent under the transition rules of the QI Program Supplemental Funding Act of 2008. In its joint-response to the citizen petitions of the Company and several other petitioners, the FDA took the position that a 30-month stay would not apply to approvals for such ANDAs.

In its response, the FDA noted that “under current law, a 30-month stay will apply to an ANDA referencing an old antibiotic if that ANDA contains a paragraph IV certification to a patent submitted to the [FDA] before the ANDA was submitted, and the NDA holder or patent owner sues the ANDA applicant for patent infringement as a result of notice of the paragraph IV certification.” Based upon the FDA’s statement, the Company believes that following the commencement of its anticipated infringement suit against Impax Laboratories, Inc. (“Impax”) it will be entitled to a 30-month stay of approval with respect to the Impax ANDA for a generic version of DORYX 150 mg delayed-release tablets.

DORYX, which Warner Chilcott markets and sells in 150, 100 and 75 mg strengths in the United States under a license agreement with Mayne Pharma International Pty. Ltd., is a tetracycline-class oral antibiotic protected by Mayne’s Patent No. 6,958,161 (the “161 Patent”) which expires in 2022. The Company and Mayne intend to vigorously defend the 161 patent and pursue their legal rights.

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