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Dr. Gerald J. Yakatan Appointed CEO of Cobalis Corp.


IRVINE, Calif. -- Cobalis Corp. (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
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), a pharmaceutical development company focused on allergy and other atopic atopic /atop·ic/ (a-top´ik) (ah-top´ik)
1. ectopic.

2. pertaining to atopy; allergic.


atopic

1. displaced; ectopic.

2. pertaining to atopy.
 conditions, announced today that specialty pharmaceutical executive Gerald J. Yakatan, Ph.D., has been appointed Chief Executive Officer, effective May 15, 2006. Dr. Yakatan replaces Chas Radovich, co-founder of Cobalis, who continues as President and as a member of the Board of Directors. Dr. Yakatan, a member of the Cobalis Board since February 2006, has a demonstrated track record in moving therapeutics through clinical trials, the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval process and to commercialization. Dr. Yakatan's appointment as CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  occurs as Cobalis progresses towards commercialization of its novel allergy medication, PreHistin(TM), currently entering its second Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the .

"Dr. Yakatan's knowledge, experience, and record of accomplishment are invaluable to our company as we strive to bring PreHistin(TM) to market," commented Chas Radovich, President. "We have migrated from start-up to the execution phase and I can think of no better leader to take the Company forward. Jerry's experience in pharmaceutical product development, regulatory affairs, and licensing are particularly important as we move to commercialize PreHistin(TM), secure licensing agreements, and establish a drug pipeline."

Dr. Yakatan served as President and CEO of Avanir Pharmaceuticals, San Diego, CA from 1998 through 2005 where he successfully directed the company's development and commercialization of novel therapeutics. He was responsible for the clinical and regulatory strategies that led to the FDA approval of Abreva(R), the largest-selling OTC treatment for cold sores, and the Neurodex(TM) NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  currently under FDA review. Dr. Yakatan spearheaded Avanir's licensing efforts that led to a partnership with GlaxoSmithKline for Abreva(R) and to R&D collaborations in major therapeutic areas with Novartis and Astra Zeneca.

Dr. Yakatan, who was awarded a Ph.D. in Pharmaceutical Sciences from the University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. , has extensive experience with compounds that inhibit the production of IgE (Immunoglobulin epsilon) antibodies. IgE is a key component in the sequence of events that results in the onset of allergy symptoms. Cobalis' flagship product candidate, PreHistin(TM) is being developed to lower IgE levels, and the company has successfully completed its initial Phase III clinical trial in allergic rhinitis Allergic Rhinitis Definition

Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances.
.

In 1996, Dr. Yakatan founded IriSys Inc. a San Diego pharmaceutical product development contract organization; he has served as President and CEO of Tanabe Research Laboratories USA, a subsidiary of Tanabe Seiyaku, a leading Japanese pharmaceutical company; as Executive Vice President, Research and Development for Immunetech Pharmaceuticals; and as Vice President of Product Development Worldwide for the Pharmaceutical Research Division of Warner-Lambert where he was also member of the Pharmaceutical Research Management Team and the Parke-Davis Executive Committee. Dr. Yakatan also served as Chairman of the Department of Pharmaceutics at the University of Texas at Austin “University of Texas” redirects here. For other system schools, see University of Texas System.
The University of Texas at Austin (often referred to as The University of Texas, UT Austin, UT, or Texas
.

"Having followed the development of PreHistin(TM) for many years, and having become more familiar with the Company, management and the recent Phase III clinical trial results over the past few months, I am excited by the opportunity to build on the progress that Cobalis' management has achieved in developing PreHistin(TM)," said Dr. Yakatan. "I believe PreHistin(TM) has the potential to make a major impact on the treatment of allergies and other atopic diseases, and I look forward to working with the Cobalis team to bring PreHistin(TM) to the marketplace."

About Cobalis Corp.

Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache Migraine Headache Definition

Migraine is a type of headache marked by severe head pain lasting several hours or more.
Description

Migraine is an intense and often debilitating type of headache.
, atopic asthma and dermatitis dermatitis (dûr'mətī`tĭs), nonspecific irritation of the skin. The causative agent may be a bacterium, fungus, or parasite; it can also be a foreign substance, known as an allergen. . Its flagship product, PreHistin(TM) - The World's First Pre-Histamine(TM) - is an allergy prevention medication that successfully completed its initial large-scale Phase III Clinical Trial in October of 2005. Upon successful completion of a second FDA-required Phase III Clinical Trial, Cobalis will seek FDA approval to market PreHistin(TM) over-the-counter in the US. Cobalis plans to commence international marketing of PreHistin in late calendar 2006 or 2007. For further information, visit http://www.cobalis.com

SAFE HARBOR Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 

Certain statements contained in this release are considered "forward-looking" statements (as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 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; 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.
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Publication:Business Wire
Date:May 11, 2006
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