IRVINE, Calif., Jan. 19 /PRNewswire-FirstCall/ -- Cobalis Corp. , a pharmaceutical development company specializing in anti-allergy medications, announced today that the Company has been notified by the FDA that the marketing approval process (IND) for its anti-allergy product, PreHistin(TM), will now be conducted within the FDA by the Office of Nonprescription Products, the branch of the FDA which handles over-the-counter (OTC) drug products.
The Company sees this as a positive development since, as an FDA-approved OTC drug, PreHistin(TM) would not require a doctor’s prescription, thus making consumer purchases easier, faster and more convenient. Based on an extensive long-term history of safety, PreHistin(TM) has been intended to be an OTC product from its inception.
Typically, drugs that are approved for OTC marketing in the US are considered safe for consumers to purchase themselves, without requiring a physician’s supervision. The market in the US for OTC allergy treatments exceeded $4.6 billion last year.
In regard to the drug approval process for PreHistin(TM), the FDA has also indicated to Cobalis that there is no distinction in the OTC environment between seasonal allergies and year-round allergies. The FDA has further indicated to the Company that it is likely that chronically allergic people would take PreHistin(TM) continuously. Thus, the anticipated indication would include both seasonal and perennial allergies which would increase the potential market for PreHistin(TM) to include not only seasonal allergies (such as hay fever), but year round allergies, such as cat, dog and other pet dander, dust mites, cockroaches and mold.
As previously announced, Cobalis has successfully completed the first of two required large-scale Phase III Clinical Trials, in which PreHistin(TM) demonstrated both clinical and statistical significance in a double-blind, placebo-controlled study of 714 allergy patients. The Company plans to engage the second Phase III Clinical Trial in the late spring of 2006.
Said Chas Radovich, CEO of Cobalis Corp.: “We are very pleased to report yet another major milestone with the news that the approval review for PreHistin(TM) is now officially in the hands of the OTC division at the FDA. Based on the extensive history of safe usage of cyanocobalamin, the primary ingredient of PreHistin(TM), we look forward to a smooth review process and to receiving OTC approval for PreHistin(TM).”
ABOUT COBALIS CORP. - PREHISTIN(TM)
Headquartered in Irvine, California, Cobalis Corp. is an over-the-counter, specialty pharmaceutical company. Its flagship product, PreHistin(TM) is currently in Phase III clinical trials and initial marketing in the U.S. will commence upon final FDA marketing approval. The U.S. anti-allergy medication market was $7.2 billion in 2003 and is expected to exceed $10 billion by 2010. PreHistin(TM), The World’s First Pre-Histamine(TM), is currently in Phase III Clinical Trials in preparation for submission to the FDA to gain OTC approval for the allergy indication.
For further information please visit the website at http://www.cobalis.com
SAFE HARBOR
Certain statements contained in this release are considered “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Investors should not rely on these forward-looking statements as assurances of future events, because such statements are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from the Company’s expectations. Factors could include, but are not limited to: risks associated with pre-clinical and clinical developments in the biopharmaceutical industry in general and in the Company’s compounds under development in particular; the potential failure of the Company’s compounds under development to prove safe and effective for treatment and prevention of disease; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies; acquisitions, divestitures, mergers, licenses or strategic initiatives that change the Company’s business, structure or projections; the development of competing products; uncertainties related to the Company’s business, structure or projections; uncertainties related to the Company’s dependence on third parties and partners; and those risks described in filings with the SEC.
Cobalis Corp.
CONTACT: Chas Radovich, CEO-President, Investor.Relations@Cobalis.com, orEarnest Armstrong, Chief Scientific Officer, EArmstrong@cobalis.com, bothof Cobalis Corp., +1-949-757-0001
Web site: http://www.cobalis.com/
