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The lawsuit is based upon Abbreviated New Drug Applications (ANDAs) filedby Mylan and Barr, each seeking U.S. Food and Drug Administration (FDA)approval for a generic equivalent of the 15 mg and 30 mg strengths of AMRIX tobe sold in the United States. The Mylan ANDA alleges that the AMRIX patentwill not be infringed by its manufacture, use or sale of the product describedin its ANDA and reserves its right to challenge the validity and/orenforceability of the AMRIX patent. The Barr ANDA alleges that the AMRIXpatent is invalid, unenforceable and/or will not be infringed by itsmanufacture, use or sale of the product described in its ANDA. AMRIX wasapproved by the FDA in February 2007 for short-term use as an adjunct to restand physical therapy for relief of muscle spasm associated with acute, painfulmusculoskeletal conditions.
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"We believe that the proposed Mylan and Barr ANDA products will be foundto infringe the AMRIX patent," said Jerry Pappert, Executive Vice Presidentand General Counsel of Cephalon. "The AMRIX patent was approved by the UnitedStates Patent and Trademark Office and is presumed by law to be valid andenforceable. The patent position for this product is strong and we intend tovigorously defend the AMRIX intellectual property."
"We believe our Orange Book-listed patent provides coverage for AMRIXuntil 2025 and we intend to work diligently with Cephalon to protect thisimportant product," said Manya S. Deehr, Eurand's Chief Legal Officer.
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 Mylanand Barr ANDAs until the earlier of a district court judgment in favor ofMylan or Barr or 30 months from the October 2008 receipt of the Mylan and BarrParagraph IV certification letters.
Eurand developed AMRIX based on its patented and proprietary drug deliveryformulation technologies. Cephalon is the exclusive licensee and marketer ofAMRIX in the United States. Concurrent with the patent protection describedabove, Cephalon has a three-year period of marketing exclusivity preventingFDA approval of a generic version of AMRIX until February 2010.
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, PROVIGIL(R)(modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II],TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone forextended-release injectable suspension), GABITRIL(R) (tiagabinehydrochloride), NUVIGIL(R) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oraltransmucosal fentanyl citrate) [C-II]. The company also markets numerousproducts internationally. Full prescribing information on its U.S. products isavailable at http://www.cephalon.com or by calling 1-800-896-5855.
About Eurand
Eurand is a specialty pharmaceutical company that develops, manufacturesand commercializes enhanced pharmaceutical and biopharmaceutical productsbased on its proprietary drug formulation technologies. Eurand has had fourproducts approved by the FDA since 2001 and has a pipeline of productcandidates in development for itself and its collaboration partners. Eurand'stechnology platforms include bioavailability enhancement of poorly solubledrugs, customized release, taste-masking/fast-dissolving formulations and drugconjugation.
Eurand is a global company with facilities in the U.S. and Europe. Formore information, visit Eurand's website at www.eurand.com.
Cephalon Forward-Looking Statement
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 Mylan ANDA product or Barr ANDAproduct infringes the AMRIX patent, the strength of the patent position forAMRIX or Cephalon's intention to defend the AMRIX intellectual property. Youmay identify some of these forward-looking statements by the use of words inthe statements such as "anticipate," "estimate," "expect," "project,""intend," "plan," "believe" or other words and terms of similar meaning.Cephalon's performance and financial results could differ materially fromthose reflected in these forward-looking statements due to general financial,economic, regulatory and political conditions affecting the biotechnology andpharmaceutical industries as well as more specific risks and uncertaintiesfacing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and10-K filed with the U.S. Securities and Exchange Commission. Given these risksand uncertainties, any or all of these forward-looking statements may prove tobe incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publiclyany forward-looking statement, except as required by law. The PrivateSecurities Litigation Reform Act of 1995 permits this discussion.
Eurand Forward-Looking Statement
This release, and oral statements made with respect to informationcontained in this release, constitutes forward-looking statements. Suchforward-looking statements include those which express plan, anticipation,intent, contingency, goals, targets or future development and/or otherwise arenot statements of historical fact including, but not limited to the future andstatus of our NDA filing for EUR-1008, enrollment and future plans for ourclinical trials, progress of and reports of results from clinical studies,clinical development plans and product development activities. The words"potentially", "anticipates", "could", "calls for" and similar expressionsalso identify forward-looking statements. These statements are based uponmanagement's current expectations and are subject to risks and uncertainties,known and unknown, which could cause actual results and developments to differmaterially from those expressed or implied in such statements. Factors thatcould affect actual results include risks associated with the possibility thatthe FDA does not approve our NDA or continues to delay approval; the outcomeof any discussions with the FDA; and unexpected delays or additionalrequirements in preparation of materials for submission to the FDA as a partof our NDA filing. Forward-looking statements contained in this press releaseare made as of this date, and we undertake no obligation to publicly updateany forward-looking statement, whether as a result of new information, futureevents or otherwise. Actual events could differ materially from thoseanticipated in the forward-looking statements.
SOURCE Cephalon, Inc.
