FRAZER, Pa., and PHILA., Pa.,October 21, 2008 — Cephalon, Inc. (Nasdaq: CEPH) and Eurand NV (Nasdaq: EURX) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Mylan Pharmaceuticals, Inc., requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX
®(Cyclobenzaprine Hydrochloride Extended-Release Capsules). In the Notice Letter, Mylan alleges that the U.S. Patent Number 7,387,793, entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants,” issued to Eurand is invalid, unenforceable and/or will not be infringed by Mylan’s manufacture, use or sale of the product described in Mylan’s ANDA submission. The Eurand patent covers extended-release formulations containing the muscle relaxant cyclobenzaprine and expires on February 26, 2025. Cephalon has a three-year period of marketing exclusivity for AMRIX that extends until February 2010.
Eurand, the developer of AMRIX, and Cephalon, the exclusive licensee and marketer of AMRIX in the United States, currently are reviewing the Notice Letter. By statute, if Eurand initiates a patent infringement lawsuit against Mylan within 45 days of the Notice Date, then the FDA would be automatically precluded from approving the Mylan ANDA until the earlier of a district court decision finding the patent invalid or not infringed or 30 months from the receipt of the Notice Letters by Eurand and Cephalon. The companies will work together to determine the most appropriate course of action.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company’s European headquarters are located in Maisons-Alfort, France.
The company’s proprietary products in the United States include: PROVIGIL®(modafinil) Tablets [C-IV], TREANDA® (bendamustine hydrochloride), FENTORA®(fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, AMRIX, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), NUVIGIL™ (armodafinil) Tablets [C-IV] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
