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Quotes & Info
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| NEXM > SEC Filings for NEXM > Form 8-K on 13-Jan-2009 | All Recent SEC Filings |
13-Jan-2009
Other Events
On January 12, 2009, NexMed, Inc. (the "Company") and Warner Chilcott Company, Inc. ("Warner") entered into an amendment (the "Amendment") to the exclusive United States licensing agreement dated November 1, 2007, as amended by amendment entered into on November 24, 2008, by and between the Company and Warner (as amended, the "Agreement"), for NexMed's proprietary topical alprostadil-based cream treatment for erectile dysfunction ("Vitaros®").
Pursuant to the Amendment, Warner has been granted an additional 20 days, or until February 2, 2009, to review the results of the October 15, 2008 meeting (the "Meeting") with the Food and Drug Administration (FDA). The purpose of the Meeting was to gain clarification on the major deficiencies cited by the FDA in their July 21, 2008 action letter regarding the New Drug Application (NDA) for Vitaros®. As such, on or before February 2, 2009, Warner must decide whether or not it wishes to continue with the development of Vitaros®. If Warner decides that it does not wish to continue with Vitaros® then the Agreement would terminate and all rights would revert back to the Company. Warner was previously granted an additional 45 days, or until January 13, 2009, to review such regulatory concerns.
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