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NexMed Amends US Licensing Pact With Warner Chilcott >NEXM

DOW JONES NEWSWIRES

NexMed Inc. (NEXM) said Tuesday it has amended its U.S. licensing agreement with Warner Chilcott Co. (WCRX) regarding NexMed's proprietary topical alprostadil-based cream treatment for erectile dysfunction known as Vitaros.
The East Windsor, N.J., drug developer said the amendment allows Warner Chilcott an additional 45 days, or until Jan. 13, 2009, to review the results of the Oct. 15 meeting with the U.S. Food and Drug Administration, according to a Securities and Exchange Commission filing.
NexMed said the purpose of the Oct. 15 meeting was to gain clarification on the major deficiencies cited by the FDA in its July 21 action letter regarding the new drug application for Vitaros.
The company said that on or before Jan. 13, 2009, Warner Chilcott must decide whether or not it wishes to continue with the development of Vitaros.
NexMed said if Warner Chilcott decides it doesn't wish to continue with Vitaros, then the licensing pact would terminate and all rights would revert back to NexMed.
The company said the pact previously gave Warner Chilcott until Saturday to review such regulatory concerns.

-By Gee L. Lee, Dow Jones Newswires; 202-862-1346

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(END) Dow Jones Newswires
11-25-08 1532ET
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