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The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filedby Watson seeking FDA approval for a generic equivalent of fentanyl buccaltablets to be sold in the United States. Watson alleges that the above twoFENTORA patents are invalid, unenforceable and/or will not be infringed byWatson's manufacture, use or sale of the product described in its ANDA.
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"We believe that the proposed Watson ANDA product infringes our patents,"said Jerry Pappert, Executive Vice President and General Counsel. "The FENTORApatents were approved by the United States Patent and Trademark Office basedon the results of extensive research by CIMA LABS. We continue to believe thatour patent position for this product is strong and intend to vigorously defendour intellectual property."
The filing of this lawsuit is provided for by the Hatch-Waxman Act, afederal statute governing certain aspects of generic drug approvals. Underthat statute, the filing of the lawsuit stays any FDA approval of the WatsonANDA until the earlier of a district court judgment in favor of Watson or 30months from the company's April 2008 receipt of a Paragraph IV certificationletter from Watson.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceuticalcompany dedicated to the discovery, development and commercialization ofinnovative products in four core therapeutic areas: central nervous system,pain, oncology and addiction. A member of the Fortune 1000, Cephalon currentlyemploys approximately 3,000 people in the United States and Europe. U.S. sitesinclude the company's headquarters in Frazer, Pennsylvania, and offices,laboratories or manufacturing facilities in West Chester, Pennsylvania, SaltLake City, Utah, and suburban Minneapolis, Minnesota. The company's Europeanheadquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:TREANDA(R) (bendamustine hydrochloride) for injection, AMRIX(R)(Cyclobenzaprine Hydrochloride Extended-Release Capsules), PROVIGIL(R)(modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection,VIVITROL(R) (naltrexone for extended-release injectable suspension),GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets[C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The companyalso markets numerous products internationally. Full prescribing informationon its U.S. products is available at http://www.cephalon.com or by calling1-800-896-5855.
In addition to historical facts or statements of current condition, thispress release may contain forward-looking statements. Forward-lookingstatements provide Cephalon's current expectations or forecasts of futureevents. These may include statements regarding anticipated scientific progresson its research programs; development of potential pharmaceutical products;interpretation of clinical results; manufacturing development andcapabilities; market prospects for its products; sales and earnings guidance;and other statements regarding matters that are not historical facts,including statements regarding whether the Watson ANDA product
