Pivotal Therapeutics Inc.

Pivotal Therapeutics Inc.

November 22, 2011 09:30 ET

Pivotal Therapeutics Launches Lead Therapeutic VASCAZEN™ in North America

WOODBRIDGE, ONTARIO--(Marketwire - Nov. 22, 2011) - Pivotal Therapeutics Inc. (CNSX:PVO), a specialty pharmaceutical company with a focus on the treatment of cardiovascular disease, is pleased to announce completion of another significant development milestone, the North American Launch of its lead therapeutic VASCAZEN, at the American Heart Association ("AHA") Scientific Sessions 2011 last week in Orlando, Florida.

"The North American launch of VASCAZEN is a significant milestone for the company," said Rachelle MacSweeney, President of Pivotal Therapeutics. "The interest in VASCAZEN as well as our novel approach and strategy in treating cardiovascular disease as a deficiency was very well received at the Conference. Our approach in combining VASCAZEN with a companion diagnostic, Omega Dx™, assists physicians in the identification, treatment and compliance monitoring of patients deficient in Omega-3."

Pivotal also presented data from its Open Label Study in which 84% of study participants initially presented with moderate to severe deficiencies in Omega-3 fatty acids prior to treatment. Following a six-week treatment period on VASCAZEN there was a rapid increase in study participants' Omega-3 levels.

"The positive response at the AHA, is very encouraging as we move forward in executing plans to mobilize our specialty sales force to penetrate the multi-billion dollar Cardiovascular market in the United States," added MacSweeney.

"The AHA represents the best in Coronary Heart Disease ("CHD") research and treatment in the world, resulting in remarkable opportunities for collaboration to advance research and treatment options for cardiovascular disease patients," commented Dr. George Jackowski, Chief Scientific Officer and Chairman of Pivotal Therapeutics. "We are successfully executing our strategy implementing the next generation in cardiovascular health management using medical foods while consistently achieving our corporate milestones. We will follow up on the interest expressed in our company during the AHA and sharing the outcomes of our REVEAL Clinical Trials which assesses the effectiveness of VASCAZEN as an aid in the dietary management of Omega-3 deficient CHD patients in elevating their Eicosapentaenoic ("EPA") and Docosahexaenoic ("DHA") Omega-3 fatty acid levels."

About Pivotal Therapeutics Inc.

With offices in Toronto, Canada and Boca Raton, Florida, Pivotal Therapeutics is a publicly traded (CNSX:PVO) specialty pharmaceutical company with a focus on the treatment of cardiovascular disease. Pivotal Therapeutics' lead product VASCAZEN is a prescription medical food formulated to meet the dietary Omega-3 deficient needs of patients with cardiovascular disease through elevating Eicosapentaenoic ("EPA") and Docosahexaenoic ("DHA") to levels associated with reduced risk of cardiovascular complications.

VASCAZEN is a >90% pure, proprietary EPA:DHA fatty acid formulation, protected by a series of both issued and pending US and foreign patents and commercialized by prescription only. This unique formulation will provide the cornerstone upon which a family of cutting edge combination products, with efficacy across a broad spectrum of cardiac care, will be commercialized.

Disclosure Notice

The information contained in this document is as of November 22, 2011. This press release contains forward-looking statements. Such forward-looking statements are subject to a number of risks, assumptions and uncertainties that could cause Pivotal's actual results to differ materially from those projected in such forward-looking statements. These statements can be identified by the use of words such as "will", "anticipate", "estimate", "expect", "project", "forecast", "intend", "plan", "believe", "project", "potential", and similar expressions with any discussion of future operating or financial performance or events. In particular, factors that could cause actual results to differ materially from those in forward looking statements include the following: Pivotal's inability to obtain additional financing on acceptable terms; growth in costs and expenses; inability to compete with others who provide comparable products; risk that the Company's products will not gain widespread market acceptance; risks relating to the Company's ability to maintain its CSNX listing. Forward-looking statements speak only as of the date made and are not guarantees of future performance. The Company undertakes no obligation to publicly update or revise any forward-looking statements contained in this document as a result of new information or future events or developments.

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