Warner Chilcott Announces Favorable Decision in DORYX Preliminary Injunction Proceedings

Warner Chilcott Announces Favorable Decision in DORYX Preliminary Injunction Proceedings


DUBLIN, Ireland, Sept. 22, 2011 (GLOBE NEWSWIRE) -- Warner Chilcott plc (Nasdaq:WCRX) today announced that the U.S. District Court for the District of New Jersey granted its motion for a preliminary injunction against Mylan Inc. and its affiliate Mylan Pharmaceuticals Inc. (together "Mylan"). The preliminary injunction prevents Mylan from launching a generic version of a DORYX 150 mg product before the District Court renders a decision in the on-going litigation relating to the U.S. Patent No. 6,958,161 (the "161 Patent") covering Warner Chilcott's DORYX products. No trial date has been set.

In granting the motion, the District Court found that Warner Chilcott and its co-plaintiff, Mayne Pharma International Pty. ("Mayne"), demonstrated a reasonable likelihood of success on the merits of their claim that the '161 Patent is valid and infringed by Mylan's 150 mg generic DORYX product.

Warner Chilcott markets and sells DORYX, a tetracycline-class oral antibiotic, in the United States under a license agreement with Mayne, which owns the '161 Patent. The DORYX 150 mg product currently represents in excess of 95% of Warner Chilcott's DORYX franchise based on total prescriptions according to IMS Health, Inc.

While Warner Chilcott and Mayne intend to continue to vigorously defend the '161 Patent and pursue their legal rights in their pending suits against Mylan and the other defendants that have submitted abbreviated new drug applications to the FDA seeking approval to manufacture and sell generic versions of a DORYX 150 mg product, the Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful or that generic equivalents of a DORYX 150 mg product will not be approved and enter the market prior to the expiration of the '161 Patent in 2022.

The Company

Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare, gastroenterology, dermatology and urology segments of the North American and Western European pharmaceuticals markets. The Company is fully integrated with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G

Forward Looking Statements

This press release contains forward-looking statements, including statements concerning our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," "intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial indebtedness, including increases in the LIBOR rates on our variable-rate indebtedness above the applicable floor amounts; competitive factors in the industry in which we operate, including the approval and introduction of generic or branded products that compete with our products; our ability to protect our intellectual property; a delay in qualifying any of our manufacturing facilities that produce our products or production or regulatory problems with either our own manufacturing facilities or third party manufacturers or API suppliers upon whom we may rely for some of our products; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, and the continued consolidation of the distribution network through which we sell our products; changes in tax laws or interpretations that could increase our consolidated tax liabilities; government regulation, including U.S. and foreign health care reform, affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; adverse outcomes in our outstanding litigation or arbitration matters or an increase in the number of litigation matters to which we are subject; the loss of key senior management or scientific staff; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; our ability to realize the anticipated opportunities from the PGP Acquisition; and the other risks identified in our periodic filings including our Annual Report on Form 10-K for the year ended December 31, 2010, and from time-to-time in our other investor communications.

We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.

CONTACT: Emily Hill

         Investor Relations

         973-907-7084

         [email protected]


 

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