Pivotal Therapeutics Inc.

Pivotal Therapeutics Inc.

December 05, 2011 14:28 ET

Pivotal Therapeutics Receives Product License in Canada for OMAZEN™

WOODBRIDGE, ONTARIO--(Marketwire - Dec. 5, 2011) - Pivotal Therapeutics Inc. (CNSX:PVO), a specialty pharmaceutical company with a focus on the treatment of cardiovascular disease and overall health, today reports having received its Product License and NPN number from Health Canada, for OMAZEN™, hereby authorizing the sale of product in the Canadian market.

The Natural Health Products Directorate ("NHPD") has concluded that OMAZEN™ is in compliance pursuant to Section 7 of the Natural Health Products Regulations and issued NPN 80028433. OMAZEN™ was specifically created to meet the needs of the Canadian market and is the trade name for Pivotal Therapeutics Inc. ("Pivotal") Omega-3, >90% pure, proprietary EPA:DHA fatty acid formulation positioned for the maintenance of good health.

"The issuance of a Canadian license and NPN number is yet again evidence that we continue to consistently deliver on our corporate milestones while successfully preparing for the commercial launch of our products," reports Eugene Bortoluzzi, Chief Executive Officer of Pivotal Therapeutics. "We are excited to be licensed to take product orders and fulfill demand for our product."

Dr. George Jackowski, Chair & Chief Scientific Officer added, "Not all Omega-3's are created equal. We believe that our combination of unique formulation, purity and supporting clinical data provides a superior alternative to what is currently available on the market. As consumers increase their awareness of interpreting product label information they will realize the superiority of OMAZEN™.

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 and overall health. 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.

OMAZEN is a >90% pure, proprietary EPA:DHA fatty acid formulation commercialized for sale and distribution in Canada for the maintenance of good health through the elevating Omega-3 fatty acid levels. The unique formulation and dosage will be available to patients and consumers who realize the health benefits of Omega-3 supplementation with a quality product.

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 December 5, 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 CNSX 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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