SAN DIEGO--(BUSINESS WIRE)-- NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, announced today that it received delivery confirmation of its response to the CMC (Chemistry, Manufacturing and Controls) concerns raised by Health Canada (the “Response”). The Response is part of the review process for its New Drug Submission (“NDS”) for Vitaros®, the Company’s topical treatment for erectile dysfunction treatment, which was filed in February 2008. Health Canada has a 45-day screening for acceptance process of the Response by their Regulatory Project Management group. The acceptance of the Response triggers a new, 150-day review cycle by the NDS reviewers for a final approval or rejection of the marketing application.
On January 19, 2010, NexMed announced that it had received a Notice of Non-Compliance (“Notice”) for its NDS pertaining to the review by the New Drugs Quality Division of the Bureau of Pharmaceutical Sciences. The Notice is a routine, end-of-review communication from Health Canada issued when additional information is required to reach final decision on product approval.
Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “NexMed met with Health Canada officials in February 2010 to discuss the deficiencies cited in their Notice. At that time, we were given guidance and reached agreement with the regulatory officials on the additional information to be included in our Response, which we then submitted in a timely manner. We look forward to receiving Health Canada’s decision and continue to be positive about the possibility of eventual product approval.”
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 in 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 including but not limited to obtain regulatory approval for marketing Vitaros in Canada.
KEYWORDS: United States North America Canada California
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical Research Science General Health