ST. DAVID'S, Bermuda, July 24 Warner ChilcottLimited (Nasdaq: WCRX) announced today that LEO Pharma A/S ("LEO Pharma") hasreceived a Right of Appeal Notice from the U.S. Patent and Trademark Office(the "USPTO"). In September 2006, the USPTO ordered a reexamination of LEOPharma's US Patent No. 6,753,013 (the "013 Patent") in response to a requestmade by Galderma R&D. The 013 Patent covers TACLONEX(R) products and certainof LEO Pharma's products in development. Warner Chilcott markets and sellsTACLONEX(R) products in the United States under a license agreement with LEOPharma and has license rights to certain products in development.
In the Right of Appeal Notice, the patent examiner allowed the specificformulation claim for TACLONEX(R) ointment, but rejected the remaining pendingclaims in the reexamination of LEO Pharma's 013 Patent. LEO Pharma intends tovigorously defend the 013 Patent and will file an appeal with the USPTO.
While we can offer no assurance as to the ultimate outcome of the appealof the reexamination proceedings, Warner Chilcott continues to believe thatLEO Pharma will succeed in maintaining the important elements of the patentprotection for TACLONEX(R) products, particularly based on the timing, extentand quality of the development work conducted by LEO Pharma with vitamin Danalogues in combination with corticosteroids.
About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company currentlyfocused on the women's healthcare and dermatology segments of the U.S.pharmaceuticals market. It is a fully integrated company with internalresources dedicated to the development, manufacturing and promotion of itsproducts. WCRX-G
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Forward Looking Statements
This press release contains forward-looking statements, includingstatements concerning our operations, our economic performance and financialcondition, and our business plans and growth strategy and product developmentefforts. These statements constitute forward-looking statements within themeaning of Section 27A of the Securities Act of 1933 and Section 21E of theSecurities 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 onthese forward-looking statements, which speak only as of their dates. Theseforward-looking statements are based on estimates and assumptions by ourmanagement that, although believed to be reasonable, are inherently uncertainand subject to a number of risks and 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(including the approval and introduction of generic or branded products thatcompete with our products); our ability to protect our intellectual property;a delay in qualifying our manufacturing facility to produce our products orproduction or regulatory problems with either third party manufacturers uponwhom we may rely for some of our products or our own manufacturing facility;pricing pressures from reimbursement policies of private managed careorganizations and other third party payors, government sponsored healthsystems, the continued consolidation of the distribution network through whichwe sell our products, including wholesale drug distributors and the growth oflarge retail drug store chains; the loss of key senior management orscientific staff; adverse outcomes in our outstanding litigation or anincrease in the number of litigation matters to which we are subject;go