HAMILTON, Bermuda, Sept. 24 Warner ChilcottLimited (Nasdaq: WCRX) announced today that its subsidiary, Warner ChilcottCompany, Inc., has filed a lawsuit against Barr Laboratories, Inc. ("Barr") inthe District Court for the District of New Jersey for infringement of theCompany's U.S. Patent No. 6,667,050 (the "050 Patent") which covers FEMCON FE,the first and only oral contraceptive that offers women the option of chewingtheir daily tablet.
The lawsuit is in response to Barr's submission of an Abbreviated New DrugApplication ("ANDA") to the U. S. Food and Drug Administration ("FDA")requesting approval to manufacture and sell a generic version of FEMCON FEprior to the expiration in 2019 of the 050 Patent. Subject to the priorresolution of the matter before the court, the Company's lawsuit results in astay of FDA approval of Barr's ANDA for 30 months from the date of theCompany's receipt of Barr's notice.
About Warner Chilcott
Warner Chilcott is a specialty pharmaceutical company focused ondeveloping, manufacturing, marketing and selling branded prescriptionpharmaceutical products in women's healthcare and dermatology in the UnitedStates. WCRX-G
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Warner Chilcott's Forward Looking Statements:
This press release contains forward-looking statements, includingstatements concerning our product development efforts. These statementsconstitute forward looking statements within the meaning of Section 27A of theSecurities 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 similarexpressions are intended to identify forward-looking statements. Readers arecautioned not to place undue reliance on these forward looking statements,which speak only as of their dates. These forward-looking statements arebased on estimates and assumptions by our management that, although we believeto be reasonable, are inherently uncertain and subject to a number of risksand uncertainties.
The following represent some, but not necessarily all, of the factors thatcould cause actual results to differ from historical results or thoseanticipated or predicted by our forward-looking statements: our substantialindebtedness; competitive factors in the industry in which we operate; ourability to protect our intellectual property; a delay in qualifying ourmanufacturing facility to produce our products or production or regulatoryproblems with either third party manufacturers upon whom we may rely for someof our products or our own manufacturing facility; pricing pressures fromreimbursement policies of private managed care organizations and other thirdparty payors, government sponsored health systems, the continued consolidationof the distribution network through which we sell our products, includingwholesale drug distributors and the growth of large retail drug store chains;the loss of key senior management or scientific staff; an increase inlitigation, including product liability claims and patent litigation;government regulation affecting the development, manufacture, marketing andsale of pharmaceutical products, including our ability and the ability ofcompanies with whom we do business to obtain necessary regulatory approvals;our ability to successfully complete the implementation of a company-wideenterprise resource planning system without disrupting our business; ourability to manage the growth of our business by successfully identifying,developing, acquiring or licensing and marketing new products, obtainregulatory approval and customer acceptance of those products, and continuedcustomer acceptance of our existing products; and other risks detailed fromtime-to-time in our periodic reports filed with the Securities and ExchangeCommission, our financial state