Warner Chilcott Announces Decision on Appeal of DORYX Preliminary Injunction
DUBLIN, Ireland, Dec. 12, 2011 (GLOBE NEWSWIRE) -- Warner Chilcott plc (Nasdaq:WCRX - News) today announced that the U.S. Court of Appeals for the Federal Circuit vacated a preliminary injunction granted by the U.S. District Court for the District of New Jersey against Mylan Inc. and its affiliate Mylan Pharmaceuticals Inc. (together "Mylan") and remanded the matter to the District Court for further proceedings. In vacating the District Court's September 2011 preliminary injunction that prohibited Mylan from launching a generic version of a DORYX 150 mg product before a decision at trial, the Federal Circuit found that the District Court failed to hold an evidentiary hearing and to make sufficient findings with respect to Mylan's invalidity defenses. Warner Chilcott and Mayne Pharma International Pty. ("Mayne"), which owns the U.S. Patent No. 6,958,161 (the "'161 Patent") covering DORYX products, intend to continue to vigorously defend the '161 Patent and pursue their legal rights in their pending suit against Mylan. More specifically, Warner Chilcott and Mayne expect to seek rehearing of today's decision at the Federal Circuit and, if necessary, seek a temporary restraining order from the District Court to allow for the consolidation of the preliminary injunction hearing with the trial on the merits. The trial is currently expected to occur in the first quarter of 2012.
Warner Chilcott markets and sells DORYX, a tetracycline-class oral antibiotic, in the United States under a license agreement with Mayne. As previously disclosed, in September 2011 Warner Chilcott received FDA approval for a dual-scored DORYX 150 mg product and filed a citizen petition requesting that the FDA refrain from granting final approval of any DORYX abbreviated new drug application ("ANDA") seeking to manufacture and sell generic versions of a DORYX 150 mg product, unless certain conditions were satisfied by the ANDA filer.
In the event that the Federal Circuit denies Warner Chilcott's and Mayne's motion for rehearing, the District Court denies Warner Chilcott's and Mayne's motion for a temporary restraining order, and Mylan receives final FDA approval of its generic version of a DORYX 150 mg product, Mylan could elect to launch its product "at risk" before the District Court renders a decision in the ongoing litigation relating to the '161 Patent. The Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful, whether the FDA will grant its citizen petition request, or whether generic equivalents of a DORYX 150 mg product will 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:
Company Contact:Rochelle FuhrmannSenior Vice President, Finance973-442-