EDMONTON, ALBERTA--(CCNMatthews - May 1, 2006) - CV Technologies Inc. (TSX:CVQ) announced today that it has obtained clearance from the U.S. Food and Drug Administration (FDA) to market its Canadian cold and flu remedy COLD-fX(R) in the United States. The unique patented active ingredient of COLD-fX (CVT-E002) has been accepted by the FDA as a New Dietary Ingredient (NDI).
On April 28th, the Board of Directors of CV Technologies formally approved management's strategic plans to launch COLD-fX(R) as an FDA cleared NDI product in the U.S.
CV Technologies' President, CEO and Chief Scientific Officer Dr. Jacqueline Shan said, "We are pleased that this significant milestone has been achieved and that our Board of Directors has given its support to proceed with management's U.S. launch plans. We have been working on strategies for the past nine months and we now look forward to executing them." The Company expects COLD-fX(R) will be available for sale in the U.S. in time for the cold and flu season in the fall of 2006.
The NDI submission to the FDA included extensive clinical and pre-clinical studies with COLD-fX(R) which were published in eight peer-reviewed medical journals demonstrating that COLD-fX(R) at the recommended dosage is safe for the general population in the United States. It also included additional toxicological and pharmacological studies and details on the quality manufacturing process which support the safety of COLD-fX(R).
Dr. Shan says, "To bring COLD-fX(R) to market as an NDI within the guidelines of the U.S. Dietary Supplement Health and Education Act requires submission of extensive evidence of safety to the FDA. Fewer than half of the NDI applications submitted are accepted by the FDA. This is an important achievement for our Company."
The Company previously announced its plan to eventually seek FDA approval for the active ingredient CVT-E002 in COLD-fX(R) as an over-the-counter (OTC) drug which would allow specific cold and flu related medical claims for the product. Initial reviews indicate that the process could take at least three years with an estimated cost of $30 million.
Dr. Shan says, "We believe pursuing this parallel strategy of both a long term OTC drug pathway and the early entry NDI route provides the best shareholder value and responds to consumer demand. Early entry into the U.S. as an NDI allows the Company to gain an understanding of consumer acceptance of COLD-fX(R) for disease prevention by strengthening and enhancing the immune system. Anticipated sales and cash flow under the NDI route will help minimize the financial risk while also assisting in the funding required for the clinical trials necessary for OTC drug approval."
The U.S. represents a major opportunity for the Company with the cold and flu market estimated at more than $3 billion annually.
ABOUT CV TECHNOLOGIES INC.
CV Technologies, founded in 1992, is a global leader in the development and commercialization of naturally derived, evidence based, clinically tested, medicines for disease prevention and health maintenance. The Company's lead product - COLD-fX(R), - the top selling cold and flu remedy in Canada according to ACNielsen, strengthens the immune system and is widely used as a leading anti-cold, anti-flu, non-prescription treatment. COLD-fX(R)'s unique, patented, mechanism of action was developed and standardized according to the Company's ChemBioPrint(R) Process. The CBP(R) process precisely identifies the chemical profile and biological activity of multi-active components in natural compounds. The CBP(R) process provides a manufacturing protocol that ensures each batch of compound delivers verifiable and provable health benefits.
Except for historical information contained herein, this release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties surrounding the success and timing of the launch of COLD fX(R) in the United States, the timing and initiation of clinical trials, and risks and uncertainties inherent in the process of commercializing products that are safe and effective. Factors that may cause such a difference include but are not limited to the risk that clinical trials may not demonstrate the safety and efficacy required to satisfy the regulatory authorities, and other matters required to bring products to market, 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; and product development. 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. All forward-looking statements are expressly qualified in their entirely by this cautionary statement. For more detailed information on the risks and uncertainties associated with the Company's products and other activities see the Company's periodic reports filed with the Canada Securities Regulators on SEDAR.