IRVINE, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Cobalis Corp. , announced today that following an oral presentation to the European Patent Office in Munich, Germany, a panel of three patent examiners accepted Cobalis’ claims for PreHistin(TM) as a unique treatment for allergies and other atopic diseases.
The patent “Cyanocobalamin Treatment in Allergic Disease”, European Patent EP1128835, grants Cobalis extensive patent protection paving the way for marketing PreHistin(TM) throughout the European Union where an estimated 80 million people suffer from seasonal and perennial allergies, as well as a host of other atopic diseases such as atopic asthma, atopic migraine and dermatitis.
PreHistin(TM) is a sublingual lozenge containing an allergy-opposing amount of cyanocobalamin that is absorbed through the buccal membrane, allowing direct introduction of the active ingredient into the bloodstream. In this manner, PreHistin(TM) is distinguished from orally-ingested cyanocobalamin which first passes through the digestive tract before the active ingredient is systemically available. As a sublingual lozenge, PreHistin(TM) has a significantly higher bioavailability of cyanocobalamin than orally-ingested tablets or capsules.
The European patent is a strong extension of Cobalis’ already-granted patent portfolio consisting of two patents in the US, and one in Australia. In addition, Cobalis’ PreHistin(TM) has patents pending in several other major pharmaceutical markets including Mexico, Canada and Japan.
Said Ernie Armstrong, Chief Scientific Officer for Cobalis: “PreHistin(TM) is truly a novel approach to treating allergic disease. PreHistin(TM) is a safe, non-drowsy and highly effective way to mitigate the onset and severity of allergy symptoms. Its mechanism of action, whereby PreHistin(TM) lowers IgE levels to reduce the release of symptom-causing histamine and other allergic inflammatory mediators into the body, is truly unique. In allowing this patent for the European Union, the European Patent Office has recognized the unique and novel approach of this breakthrough treatment, paving the way for Cobalis to market PreHistin(TM) to the estimated 80+ million allergy sufferers throughout Europe as an alternative to the currently available antihistamines, which are typically sedating and may have numerous unpleasant side effects. In contrast, PreHistin(TM) is completely non-sedating and there have been no known common side effects reported in our clinical studies.”
Said Marty Marion, Cobalis’ Chief Marketing Officer: “The European Union patent adds an important dimension to our international franchise for PreHistin(TM) and further demonstrates the uniqueness of this alternative treatment for allergic and atopic disease. As we continue to develop clinical applications for PreHistin(TM) to treat allergies, as well as atopic asthma, atopic migraine and other diseases triggered by IgE (Immunoglobulin E) overproduction, our expanding base of international patents adds tremendous value to our growing product portfolio and to our Company. It is estimated that in many countries atopic disease affects as much as 75% of the population. PreHistin(TM) will provide consumers with the safest, most effective and least costly approach to controlling and treating allergic disease. Patents, such as the European Union patent, allow us a strong protective playing field in which to bring our product to market.”
Following translation and publication of the European Union patent application into French, German and several other EU languages, Cobalis expects the European Patent Office to publish the official allowance of the patent early in 2006. Cobalis intends to commence marketing PreHistin(TM) in Europe in 2006 following formal publication of the issued EU patent.
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), has shown in previous studies to modulate the body’s level of the protein IgE, thereby reducing the overproduction of histamines, the primary cause of airborne allergy symptoms. Prior studies have shown that the active ingredient in PreHistin(TM) appears to have essentially no risks of adverse effects to the general population, including sedation and drowsiness found in many of the allergy products currently available.
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. These forward-looking statements are identified by their use of terms and phrases such as “believe,” “expect,” “plan,” “anticipate,” “possibility” and similar expressions identifying their forward-looking character. 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. Specifically, factors could include, but are not limited to: risks associated with preclinical 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 for the Company’s compounds under development; 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; the development of competing products; 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, Cobalis Corp., +1-949-757-0001,Investor.Relations@Cobalis.com; Tim Clemensen, Senior Vice President,Rubenstein Investor Relations, +1-212-843-9337,TClemensen@RubensteinIR.com; Michelle Manoff, Senior Vice President,Rubenstein Public Relations, +1-212- 843-8051, MManoff@RubensteinPR.com
Web site: http://www.cobalis.com/
