HAMILTON, Bermuda and CORONA, Calif., Jan. 12 Watson Pharmaceuticals, Inc. (NYSE: WPI) and Warner Chilcott Limited (Nasdaq:WCRX) announced today that they have entered into Settlement and LicenseAgreements to resolve pending patent litigation related to Warner Chilcott'soral contraceptive products, Loestrin(R) 24 and Femcon(R) Fe. Separately,Warner Chilcott and Watson have entered into a Co-Promotion Agreement relatingto Warner Chilcott's Femring(R) product and License and Supply Agreementsrelating to a Warner Chilcott development-stage oral contraceptive product.
Loestrin(R) 24 and Femcon(R) Fe Settlement and License Agreements
Under the terms of the settlement agreements, Warner Chilcott has grantedWatson a non-exclusive license to the U.S. patents covering Loestrin(R) 24 Fe(norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumaratetablets) and Femcon(R) Fe (norethindrone, ethinyl estradiol tablets, chewable,ferrous fumarate tablets). The agreement covering Loestrin(R) 24 Fe willpermit Watson to commence marketing its generic equivalent product on theearlier of January 22, 2014 or the date on which another generic version ofLoestrin(R) 24 Fe enters the U.S. market. The agreement covering Femcon(R) Fewill permit Watson to commence marketing its generic equivalent product on theearlier of 180 days after Barr Laboratories, Inc. (now Teva PharmaceuticalIndustries, Ltd.) enters the market with a generic equivalent product, orJanuary 1, 2013. The parties will promptly file dismissals without prejudicethat will conclude both litigations. Additional details concerning thesettlements have not been disclosed.
In a separate agreement, Watson will co-promote Warner Chilcott's hormonetherapy product, Femring(R). Watson's Specialty Products sales force willpromote the product to obstetricians and gynecologists commencing in 2009, forwhich it will receive fee-based compensation. Warner Chilcott will also payWatson a portion of the net sales of Femring(R) above an agreed upon level forthe duration of the agreement. Warner Chilcott's net sales of Femring(R) wereapproximately $15.7 million for the twelve months ended September 30, 2008.
License and Supply Agreements
Under separate license and supply agreements, Warner Chilcott has grantedWatson an exclusive license to market and sell an oral contraceptive product(WC3026) currently in late-stage development. Warner Chilcott is responsiblefor completing development and obtaining approval of this product and expectsto submit a new drug application to the FDA in the second half of 2009.Warner Chilcott will exclusively supply Watson with the product on a cost plusmargin basis and Watson will pay Warner Chilcott royalties based on productnet sales.
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 U.S.WCRX-G
Read more on http://www.warnerchilcott.com.
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(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;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 manage the growth of our business by successfully identifying,developing, acquiring or licensing new products at favorable prices andmarketing such new products; our ability to obtain regulatory approval andcustomer acceptance of new products, and continued customer acceptance of ourexisting products; changes in tax laws or interpretations that could increaseour consolidated tax liabilities; the other risks identified in our AnnualReport on Form 10-K for the year ended December 31, 2007; and other risksdetailed from time-to-time in our public filings, financial statements andother investor communications.
We caution you that the foregoing list of important factors is notexclusive. In addition, in light of these risks and uncertainties, the mattersreferred to in our forward-looking statements may not occur. We undertake noobligation to publicly update or revise any forward-looking statement as aresult of new information, future events or otherwise, except as may berequired by law.
Press inquiries: Rochelle Fuhrmann, Senior Director, Investor Relations ofWarner Chilcott Limited, +1-973-442-3281, [email protected]
or PattyEisenhaur, Executive Director, Investor Relations of Watson Pharmaceuticals,Inc., 951-493-5611, [email protected]
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading specialty pharmaceutical companythat develops, manufactures, markets, sells and distributes generic andspecialty brand pharmaceutical products. Watson pursues a growth strategycombining internal product development, strategic alliances and collaborationsand synergistic acquisitions of products and businesses.
For press releases and other company information, visit WatsonPharmaceutical's Web site at http://www.watson.com.
Watson's Forward-Looking Statement
Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, risks that resolution of patent infringement litigation throughsettlement could result in investigations or actions by private parties orgovernment authorities, including the U.S. Department of Justice and /or theFederal Trade Commission; the difficulty of predicting the timing or outcomeof product development efforts and FDA or other regulatory agency approvals oractions, if any; risks that development efforts, including clinical studiesand other information, will not be sufficient to support FDA approval ofdevelopment stage products; delays regarding the regulatory approval process,including the timing and scope of approval received, if any; the impact ofcompetitive products and pricing, market acceptance of and continued demandfor Watson's products; difficulties or delays in manufacturing; and otherrisks and uncertainties detailed in Watson's periodic public filings with theSecurities and Exchange Commission, including but not limited to Watson'sAnnual Report on Form 10-K for the year ended December 31, 2007.
SOURCE Watson Pharmaceuticals, Inc.; Warner Chilcott Limited