Published:
Ortho-McNeil Neurologics to Appeal Patent Ruling on RAZADYNE(R)
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 ofDelaware, 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 inthe
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 inTitusville, 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.)
SOURCE Ortho-McNeil Neurologics
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