Shawshank, VA 5/25/12 (StreetBeat) – There are plenty of milestones for any company, but navigating the regulatory pathway for biotechnology companies to bring a product to market can be an especially daunting task. Ontario-based Pivotal Therapeutics Inc. (OTCBB:PVTTF) has successfully run the Food and Drug Administration gauntlet and now today reported that prescription sales of their lead therapeutic product VASCAZEN™ have begun in the United States. Manufactured according to FDA current Good Manufacturing Practices (cGMP), VASCAZEN™ is prescription-only medical food for the aid in the dietary management of Omega-3 deficient cardiovascular disease patients. To date, Pivotal is the only company to introduce an FDA regulated prescription-grade Omega-3 fatty acid medical food for the clinical dietary management of Omega-3 deficiency in patients with cardiovascular disease.
What’s “medicinal food?” According to the FDA, it is “a food which is formulated to be consumed or administered orally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
The prowess of Omega-3 has long been known for a wide array of benefits. Although some people use it for the cosmetic benefits of making the skin look better, it is used for medicinal purposes as Omega-3 deficiency is believed to and/or proven to have an impact in many diseases and ailments, including plays arthritis, angina, autoimmune diseases and even cancers and autism, to name a few.
Studies at Harvard University released in 2009 showed that Omega-3 deficiency causes 96,000 deaths in the United States each year; ranking it as the sixth largest killer of Americans annually. That figure even outpaces the perils of excessive trans-fat intake.
Pivotal Therapeutics Inc. Open Label Study, released in September, 2011, showed VASCAZEN™ to effectively correct an Omega-3 deficiency in study participants within four to six weeks.
Each capsule of Pivotal’s VASCAZEN™ provides 680 milligrams of Eicosapentaenoic (EPA) and 110 milligrams of Docosahexaenoic (DHA) Omega-3 fatty acids for oral administration. The recommended 4 capsules/day dose delivers 3 grams of EPA and DHA, attaining levels that cannot be reasonably achieved through normal diet alone, according to the company.
Pivotal is also crossing another substantial hurdle with recognition and reimbursement for VASCAZEN™ with prescriptions now available in a vast majority of pharmacies throughout the States and partial reimbursement being delivered from a growing number of the nation’s largest private insurers.
"VASCAZEN's™ rapid entry into the US market is a reflection of physician interest that is being expressed for Pivotal's approach to cardiovascular disease as a dietary deficiency of Omega-3,” said Rachelle MacSweeney, President, Pivotal Therapeutics. "The response we are receiving from the medical community has been very positive and we believe that continued demonstration of VASCAZEN's™ effectiveness will lead to continued interest and growing sales."
The company also produces OMAZEN™ which is commercialized for sale and distribution in Canada. Much like VASCAZEN, it is a greater than 90% pure, proprietary EPA:DHA fatty acid formulation.
With the commercialization in Canada and now sales starting to stream in from the U.S., shares of Pivotal Therapeutics look to have found a bottom early in 2012. After briefly dipping below 20 cents each, shares are making higher lows and trading at 29 cents, heading into the closing bell; representing a gain of 11.54 percent over yesterday’s closing price.
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