CV Technologies Inc. (TSX:CVQ) today announced that Health Canada has approved wide-ranging new health claims for COLD-fX®. After an extensive review, the Natural Health Products Directorate (NHPD) - Health Canada's division responsible for evaluating the safety, efficacy and quality of natural health products (NHPs) - has issued a product license and natural product number (NPN) for COLD-fX®.
The comprehensive treatment claim for COLD-fX® approved by Health Canada states that the product "helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system." Comprehensive therapeutic claims require support by the highest level of scientific evidence: randomized, double-blind, placebo-controlled clinical trials.
"This is our strongest point of medical recognition to date and coming from the government authority whose responsibility it is to help Canadians maintain and improve their health, this approval should give great confidence to consumers," said Dr. Jacqueline Shan, president, CEO and Chief Scientific Officer of CV Technologies.
The NHPD's safety review confirmed the excellent safety profile of COLD-fX with no known side effects or drug interactions for generally healthy individuals.
Dr. Shan continued, "This Health Canada approval means the Company will now be permitted to communicate more effectively about the health benefits of COLD-fX to consumers, health care practitioners and others interested in the Company and its products."
Health Canada established new regulations effective Jan. 1, 2004, to monitor and manage the NHP industry. CV Technologies was the first company in Canada to launch and complete a trial under the new regulations. These regulations are being phased in over a six-year period as the NHPD reviews supporting safety, efficacy and quality information for all natural health products.
COLD-fX® is the number one selling cold and flu remedy in Canada. (ACNielsen's MarketTrack Drug Service for Cold Remedies, Natural Supplements & Vitamins Categories for the 52-week period ending September 2, 2006).
About CV Technologies Inc.
CV Technologies, founded in 1992, is a global leader in the development and commercialization of naturally derived, evidence based, natural therapeutics for disease prevention and health maintenance. The Company's lead product - COLD-fX - strengthens the immune system and is widely used as a leading over the counter remedy (OTC) for preventing and relieving cold infections in Canada. In the United States it is marketed as an immune enhancing dietary supplement. COLD-fX, with its unique and patented mechanism of action was standardized according to the Company's ChemBioPrint (CBP) Process. The CBP process precisely identifies the chemical profile and biological activity of multi-active compounds in evidence-based natural therapeutics. The CBP process also provides a manufacturing protocol that ensures each batch of the final product delivers verifiable and provable health benefits. International manufacturing, marketing, patents and trademarks are held by fX Life Sciences International GmbH. COLD-fX is distributed and sold in the U.S. by COLD-fX Pharmaceuticals (USA) Inc. Both companies are wholly-owned subsidiaries of CV Technologies Inc. fX Life Sciences International GmbH and COLD-fX Pharmaceuticals (USA) Inc. maintain a call center for product information: 1-877-490-3300.
This news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results or events to differ materially from the results or events predicted in this discussion, including those comments predicting the timing and/or initiation of clinical trials, clinical trial results and associated regulatory clearances. Factors which could cause actual results or events to differ include, but are not limited to: the impact of competition; consumer confidence and spending levels; general economic conditions; interest and currency exchange rates; unseasonable weather patterns; the cost and availability of capital; the cost and availability of grants/funding; product development and the risk that clinical trials may not demonstrate the safety and efficacy required to satisfy the regulatory authorities. Although we believe that the forward-looking statements contained herein are reasonable, we can give no assurance that our expectations are correct and that the results, performance or achievements expressed in, or implied by, forward-looking statements within this disclosure will occur, or if they do, that any benefits may be derived from them, including benefits as a result of obtaining a product license and NPN from Health Canada. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a more in-depth account of risks and uncertainties, please refer to documents filed with the securities regulators on www.sedar.com. The Company assumes no duty to update this disclosure.