NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT ® technology, today provided an update on the status of its New Drug Submission (“NDS”) with Health Canada for Vitaros ® , the Company’s topical treatment for erectile dysfunction.
NexMed management has been advised that Health Canada is continuing to review its response for acceptance, and the Company expects to hear from the agency within the next 30 days. An acceptance of the response by Health Canada will trigger a new, 150-day review cycle by the NDS reviewers for a final approval or rejection of the marketing application.
On April 23, 2010, NexMed reported that it had received delivery confirmation of its response to the CMC (Chemistry, Manufacturing and Controls) concerns previously raised by Health Canada (the "Response") related to its New Drug Submission for Vitaros, which was filed in February 2008. The delivery confirmation provided Health Canada with a 45-day screening for acceptance process of the Response by their Regulatory Project Management group, or until approximately June 4, 2010.
Management of NexMed also stated today that the Company is not currently selling shares of its common stock pursuant to the agreement with Brinson Patrick Securities Corporation. Further information concerning the agreement with Brinson is available pursuant to the Company’s Form 10Q filed on May 13, 2010.About NexMed, Inc. NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and i n vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT ® drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com. Forward-Looking Statement Safe Harbor Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company. For example, and without limitation, there can be no assurance that Health Canada will accept the Company’s response for review or approve Vitaros for sale in Canada.