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The decision allows FDA-approved generic versions of immediate-releasegalantamine hydrobromide to enter the U.S. marketplace "at risk" pending anappeal. A favorable ruling would have provided patent protection forRAZADYNE(R) IR until the patent expires on December 14, 2008.
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"We are disappointed by the court's decision and will appeal this ruling,"said Janet Vergis, President of Janssen and Ortho-McNeil Neurologics. "Webelieve the patent protecting RAZADYNE(R) is valid and would be infringed bythe introduction of a generic galantamine hydrobromide product."
Barr Laboratories and AlphaPharm Pty Ltd. filed Abbreviated New DrugApplications ("ANDAs") to market galantamine hydrobromide before theexpiration of the patent, claiming the patent was invalid. Janssen, JanssenPharmaceutica N.V., and patent owner Synaptech Inc. filed a patentinfringement complaint against Barr and AlphaPharm in June 2005. Otherlawsuits against generic companies seeking to market galantamine hydrobromidebefore the expiration of the patent are bound by the outcome of this case.
RAZADYNE and RAZADYNE ER are marketed by Ortho-McNeil Neurologics in theUnited States, and are indicated in the treatment of mild to moderate dementiaof the Alzheimer's type.
Important Safety Information
In clinical trials, the most common side effects are nausea, vomiting,diarrhea, loss of appetite and weight loss. Typically, these side effects aremild and temporary. RAZADYNE(R) and RAZADYNE(R) ER may not be for everyone.Some people experience a slowed heart rate, which may lead to fainting.Serious stomach problems can occur in people taking medications such asnonsteroidal anti-inflammatory drugs (NSAIDs) or those at risk for stomachulcers.
Please see www.RAZADYNEER.com for full prescribing information.
About Ortho McNeil Neurologics(R)
Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Division ofOrtho-McNeil-Janssen Pharmaceuticals Inc., focuses exclusively on providingsolutions that improve neurological health. The company currently marketsproducts for Alzheimer's disease, epilepsy and acute and preventative migrainetreatment. Ortho-McNeil Neurologics, in conjunction with internal and externalresearch partners, continues to explore new opportunities to develop solutionsfor unmet healthcare needs in neurology. Ortho-McNeil-Janssen Pharmaceuticals,Inc. and Janssen Pharmaceutica N.V. are part of the Johnson & Johnson familyof companies."
Forward-Looking Statement
(This press release contains "forward-looking statements" as defined inthe Private Securities Litigation Reform Act of 1995. These statements arebased on current expectations of future events. If underlying assumptionsprove inaccurate or unknown risks or uncertainties materialize, actual resultscould vary materially from the Company's expectations and projections. Risksand uncertainties include general industry conditions and competition;economic conditions, such as interest rate and currency exchange ratefluctuations; technological advances and patents attained by competitors;challenges inherent in new product development, including obtaining regulatoryapprovals; domestic and foreign health care reforms and governmental laws andregulations; and trends toward health care cost containment. A further listand description of these risks, uncertainties and other factors can be foundin Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscalyear ended December 30, 2007. Copies of this Form 10-K, as well as subsequentfilings, are available online at www.sec.gov, www.jnj.com or on requ
