Navigation Links
Ortho-McNeil Neurologics to Appeal Patent Ruling on RAZADYNE(R)
Date:8/28/2008

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 http://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 http://www.sec.gov, http://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
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
2. WorldHeart Announces Delisting Appeal Received and Will be Considered at Hearing July 10, 2008
3. Wyeth To Appeal Arkansas Hormone Therapy Trial Verdicts
4. Insmed to Appeal Delisting Notification From Nasdaq
5. Genta Completes Appeal of FDA Decision for Genasense(R) in CLL
6. XTL to Appeal NASDAQ Staff Determination; XTL May Transfer its ADR Listing to the NASDAQ Capital Market
7. Forest Laboratories Announces Federal Appeals Court Upholds Lexapro(R) Patent Decision
8. Lixte Biotechnology Holdings Announces Filing of a New Patent Application for Cancer Therapy Based on Targeting a Biomarker by Novel Investigational Agents
9. Indevus Pharmaceuticals Announces Issuance of U.S. Patent for SANCTURA XR(TM)
10. Bion Announces Approval of New U.S. Patent for Phosphorus Removal Process for Livestock Waste Environmental Treatment
11. ImmunoVaccine Technologies Broadens Its Patent Protection to Japan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... Charm Sciences, Inc. is ... has received AOAC Research Institute approval 061601. , “This is another AOAC-RI approval ... Bob Salter, Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... today announced the launch of the Supplyframe Design Lab . Located in ... to explore the future of how hardware projects are designed, built and brought ...
(Date:6/23/2016)... June 23, 2016  Blueprint Bio, a company dedicated ... the medical community, has closed its Series A funding ... . "We have received a commitment from ... we need to meet our current goals," stated ... the runway to complete validation on the current projects ...
(Date:6/23/2016)... ... June 23, 2016 , ... Regulatory Compliance Associates® ... provides a free webinar on Performing Quality Investigations: Getting to Root ... CT at no charge. , Incomplete investigations are still a major concern to ...
Breaking Biology Technology:
(Date:6/15/2016)... , June 15, 2016 ... market report titled "Gesture Recognition Market by Application Market - Global ... 2016 - 2024". According to the report, the  global ... billion in 2015 and is estimated to grow ... 48.56 billion by 2024.  Increasing application ...
(Date:6/7/2016)... -- Syngrafii Inc. and San Antonio Credit Union (SACU) ... Syngrafii,s patented LongPen™ eSignature "Wet" solution into SACU,s ... in greater convenience for SACU members and operational ... document workflow and compliance requirements. Logo ... Highlights: ...
(Date:6/2/2016)... The Weather Company , an IBM Business (NYSE: IBM ... which consumers will be able to interact with IBM Watson ... or text and receive relevant information about the product or ... long sought an advertising solution that can create a one-to-one ... valuable; and can scale across millions of interactions and touchpoints. ...
Breaking Biology News(10 mins):