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 a 150 day review cycle by the NDS reviewers.
About NexMed
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 also has a proprietary product pipeline based on its NexACT drug delivery technology. 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 successfully resolve the issues identified by Health Canada in the Notice or that Vitaros will receive marketing approval from Health Canada or other regulatory body.
Contacts:
NexMed:
NexMed, Inc.
Ed Cox, 858-926-5811
VP- IR
ecox@nexmed.com
or
NexMed
Investor Relations:
Rx Communications Group, LLC
Paula
Schwartz, 917-322-2216
pschwartz@rxir.com
