BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Ortho-McNeil Neurologics, Inc. to Appeal Patent Ruling on RAZADYNE(R)


8/29/2008 7:17:37 AM

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/



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->