Neurobiological Technologies, Inc. Reports FDA Has Accepted Forest Lab's sNDA Filing to Expand Namenda's Indication to Include Mild Alzheimer's Disease
Posted on: Monday, 15 November 2004, 18:00 CST
RICHMOND, Calif., Nov. 15 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. , a biotechnology company engaged in the business of acquiring and developing central nervous system (CNS) related drug candidates, today reports that the U.S. Food and Drug Administration has accepted Forest Laboratories' filing of a supplemental New Drug Application (sNDA) that would expand the indication of Namenda(R) (memantine HCl) to include treatment for mild Alzheimer's Disease.
Currently, Namenda is indicated for moderate and severe forms of the disease and should the FDA approve the application, it would be the first drug approved in the US to treat all stages of Alzheimer's disease.
Paul E. Freiman, president and CEO, stated, "Forest Laboratories' filing has the potential to expand demand for Namenda by increasing the number of patients whose doctors could prescribe it for the early treatment of Alzheimer's disease. We believe that early treatment is likely to provide greater benefits to patients."
Memantine received approval for the treatment of Alzheimer's disease in Europe in 2002 and in the U.S. in 2003. In Europe, memantine has been marketed by Merz & Co. for a number of indications for several years. For Alzheimer's disease, memantine is now being sold by Merz's European marketing partner, H. Lundbeck A/S. In the U.S., memantine is currently being sold by Forest Laboratories for moderate-to-severe Alzheimer's disease under the brand name Namenda. Under an exclusive marketing agreement, NTI receives royalty payments by Merz and its marketing partners from sales of memantine for Alzheimer's disease.
Forest Laboratories is also evaluating Namenda for the treatment of neuropathic pain and is currently conducting Phase IIB/III human clinical studies.
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc. is a biotechnology company engaged in the business of acquiring and developing central nervous system (CNS) related drug candidates. The company is focused on therapies for neurological conditions that occur in connection with dementia, Alzheimer's disease, ischemic stroke, neuropathic pain, and brain cancer.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including our dependence on Merz and its marketing partners for the successful commercialization of memantine, as well as their ability to meet regulatory requirements and other risks detailed from time to time in our Securities and Exchange Commission filings. These forward-looking statements represent our judgment as of the date of the release. We disclaim, however, any intent or obligation to update these forward-looking statements.
Neurobiological Technologies, Inc.
CONTACT: Paul E. Freiman, President & CEO of NeurobiologicalTechnologies, Inc., +1-510-262-1730; or Cheryl Schneider, VP - InvestorRelations, or Jeff Myhre, VP - Editorial, +1-212-564-4700, both of Porter,Le Vay & Rose, Inc., for Neurobiological Technologies, Inc.
Web site: http://www.ntii.com/
Source: PRNewswire-FirstCall
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