NEXMED RECEIVES SCREENING ACCEPTANCE LETTER FROM HEALTH CANADA FOR VITAROS®
150-day Review Cycle Triggered for Final Approvability of Product in Canada
San Diego--(BUSINESS WIRE)-- NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of product candidates based on the NexACT® technology, today announced that Health Canada has confirmed acceptance of the Company's CMC (Chemistry, Manufacturing and Controls) response for review. The Screening Acceptance Letter (the "Acceptance Letter") from Health Canada was issued in connection with its New Drug Submission ("NDS") for Vitaros® , the Company's topical treatment for erectile dysfunction. The Acceptance Letter confirms that the CMC response filed by NexMed is acceptable for the final, 150-day review cycle, during which regulatory reviewers will determine the final approvability of the product for marketing in Canada. Based on the date of acceptance, a final approval decision is expected by the end of November 2010.
Commenting on today's news, Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, "Receipt of the Acceptance Letter marks another important milestone in the development history of Vitaros® and we remain positive about the possibility for eventual product approval. As such, we anticipate utilizing our Canadian application as the basis for filing new marketing applications in other international markets."
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 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. For example, and without limitation, there can be no assurance that Health Canada or any other foreign regulatory authority will approve Vitaros® for marketing approval.
Edward Cox, V.P.
Investor Relations & Corporate Development NexMed, Inc.
NexMed Investor Relations
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