NEXMED UPDATES ON CANADIAN APPROVAL PROCESS FOR VITAROS®
San Diego, CA, January 19, 2010 --NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, announced today that it received a Notice of Non-Compliance ("Notice") as part of the review process from Health Canada for its New Drug Submission ("NDS") for the Vitaros® erectile dysfunction treatment filed in February 2008. The deficiencies cited related to the product's CMC (Chemistry, Manufacturing and Controls). There were no pre-clinical or clinical deficiencies cited in the Notice. The Notice is a routine end-of-review communication from Health Canada when additional information is needed to reach final decision on product approval.
Dr. Bassam Damaj, NexMed's Chief Executive Officer said, "The Notice provides us with a clear pathway to obtaining marketing approval of the product in Canada. The FDA had previously raised most of Health Canada's CMC issues and we were successful in working out a compliance plan with them. We look forward to discussing Health Canada's specific concerns in a face-to face meeting which will be our first since we filed the NDS. In the meantime, we remain optimistic about the approvability of our Vitaros® product in Canada."
The normal process of follow up to the Notice is that NexMed has 90 days from the date of the Notice to respond to Health Canada, followed by the Health Canada 45 day screening process in the Regulatory Project Management group and then a150 day review cycle by the NDS reviewers.
About NexMed, Inc.
NexMed, due to its recent acquisition of Bio-Quant, is the largest specialty contract research organization ("CRO") based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. NexMed has a proprietary product pipeline based on its NexACT® drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information, go to www.nexmed.com and 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 the Company will receive favorable approvability decisions from Health Canada or the FDA within the anticipated time frames or at all, the Company's research and development activities will yield the desired results, the Company will be able to achieve or will continue to pursue its product development goals, the Company will be able to execute on its partnering strategies, the Company will be able to satisfy NASDAQ continued listing standards, and that the Company will be able to integrate its business following the Bio-Quant acquisition in a successful manner.
NexMed Investor Relations:
Mark Westgate, CFO Paula Schwartz
NexMed, Inc. Rx Communications Group, LLC
(609) 371-8123, ext: 159 (917) 322-2216
Edward Cox, V.P.
Investor Relations & Corporate Development NexMed, Inc.