HAMILTON, Bermuda, Sept. 17 Warner ChilcottLimited (Nasdaq: WCRX) announced today that LEO Pharma A/S ("LEO") hasreceived a non-final Action Closing Prosecution from the U.S. Patent andTrademark Office (the "USPTO"). In September 2006, the USPTO ordered areexamination of LEO's US Patent No. 6,753,013 (the "013 Patent") in responseto a request made by Galderma R&D. The 013 Patent covers TACLONEX and certainof LEO's products in development. Warner Chilcott markets and sells TACLONEXin the United States under a license agreement with LEO and has license rightsto certain products in development.
In the non-final Action Closing Prosecution the patent examiner allowedthe specific formulation claim for TACLONEX ointment, but rejected theremaining pending claims in the reexamination of LEO's 013 Patent. LEO intendsto vigorously defend the 013 Patent and will file a response with the USPTO.
While we can offer no assurance as to the ultimate outcome of thereexamination proceedings, including any related appeals, Warner Chilcottcontinues to believe that LEO will succeed in maintaining the importantelements of the patent protection for TACLONEX, particularly based on thetiming, extent and quality of the development work conducted by LEO withvitamin D analogues in combination with corticosteroids.
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 are basedon estimates and assumptions by our management that, although we believe to bereasonable, are inherently uncertain and subject to a number of risks anduncertainties.
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; our