TITUSVILLE, N.J., Aug. 28 /PRNewswire/ -- Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced that it will appeal yesterday’s decision by the U.S. District Court of Delaware, which ruled the patent for RAZADYNE(R) (galantamine hydrobromide) is invalid.
The decision allows FDA-approved generic versions of immediate-release galantamine hydrobromide to enter the U.S. marketplace “at risk” pending an appeal. A favorable ruling would have provided patent protection for RAZADYNE(R) IR until the patent expires on December 14, 2008.
“We are disappointed by the court’s decision and will appeal this ruling,” said Janet Vergis, President of Janssen and Ortho-McNeil Neurologics. “We believe the patent protecting RAZADYNE(R) is valid and would be infringed by the introduction of a generic galantamine hydrobromide product.”
Barr Laboratories and AlphaPharm Pty Ltd. filed Abbreviated New Drug Applications (“ANDAs”) to market galantamine hydrobromide before the expiration of the patent, claiming the patent was invalid. Janssen, Janssen Pharmaceutica N.V., and patent owner Synaptech Inc. filed a patent infringement complaint against Barr and AlphaPharm in June 2005. Other lawsuits against generic companies seeking to market galantamine hydrobromide before the expiration of the patent are bound by the outcome of this case.
RAZADYNE and RAZADYNE ER are marketed by Ortho-McNeil Neurologics in the United States, and are indicated in the treatment of mild to moderate dementia of 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 are mild 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 as nonsteroidal anti-inflammatory drugs (NSAIDs) or those at risk for stomach ulcers.
Please see www.RAZADYNEER.com for full prescribing information.
About Ortho McNeil Neurologics(R)
Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc., focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer’s disease, epilepsy and acute and preventative migraine treatment. Ortho-McNeil Neurologics, in conjunction with internal and external research partners, continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology. Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica N.V. are part of the Johnson & Johnson family of companies.”
Forward-Looking Statement
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward- looking statements as a result of new information or future events or developments.)
CONTACT: Media, Kara Russell, +1-609-730-3592, or Investors, Louise
Mehrotra, +1-732-524-6491, or Lesley Fishman, +1-732-524-3922, all for
Ortho McNeil Neurologics
Web site: http://www.RAZADYNEER.com/
http://www.jnj.com/
