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Pivotal Therapeutic's Omega-3 Vascazen Product: The Way To The Heart

For years, we have been told that Omega 3s can help boost health. But some of us may need more than a little fish to make the difference. Pivotal Therapeutics (OTCQX:PVTTF) (CNSX:PVO) has an U.S. regulated Omega 3 prescription product on its hands that could change the face of cardiovascular treatment, with the company now working toward boosting its sales presence.

The product, Vascazen, is an FDA-regulated medical food product developed to lower cardiovascular health risks in Omega-3 deficient cardiac patients, including high triglycerides, or fatty substances in the blood that are associated with coronary disease.

The 90 percent-pure product, which was introduced in the U.S. in November 2011, provides those suffering from heart disease with levels of the most important Omega-3 fatty acids in fish oil - EPA and DHA - that the company's founder and chief scientific officer, Dr. George Jackowski, says are ideal, and cannot be achieved just through simple changes in diet alone.

Eicosapentaenoic acid (EPA), which has strong anti-inflammatory properties, and docosahexaenoic acid (DHA) are found in cold water fish such as salmon, mackerel, halibut, sardines, tuna, and herring, but without enough fish, supplements are needed to fill the body's needs.

"Our ratio of 6 to 1 for EPA to DHA is unique. Omega 3 products with pure EPA don't have the DHA required to give the necessary cardiac protection, essentially only providing half the solution," Dr. Jackowski, a biotech entrepreneur with more than 25 years of experience under his belt, tells Proactive Investors.

He also says there is a growing concern between prescription grade and regular over-the-counter brands of fish oils. "The majority of Omegas we see are 30 to 60 percent pure. The over-the-counter market is not regulated in terms of content, meaning what they say on the bottle and what they have in it could be two different things."

Omega 3s are widely known to result in improved blood flow, reduced inflammation, and positive effects on lipid metabolism, but what is not known is that these effects are determined by the purity and the ratio of EPA to DHA, says the Woodbridge, Ontario-based company.

Vascazen's daily recommended dose of 4 soft-gel capsules delivers three grams of EPA and DHA - attaining levels that cannot be "reasonably achieved" through normal diet alone. According to the 2005 U.S. Dietary Guidelines Advisory Committee, 70 percent of Americans are Omega-3 fatty acid deficient.

The Vascazen target market is the US cardiovascular disease patient population of 82.6 million - 90 per cent of whom have high concentrations of triglycerides (NYSE:TG) in their blood. "The proportion of this patient population that uses prescription medication for hypertriglyceridemia is negligible, suggesting an ignorance or uncertainty about the need to reduce cardiac disease risk by lowering triglycerides," analyst Juan Noble of Taglich Brothers wrote in a research note about the company late last year.

But lowering high triglyceride levels is not the only benefit from Omega 3s, as the fish oils have the power to bring entire "lipid profiles back to a level of normality", says Dr. Jackowski, who is responsible for creating 12 biotech companies, including Synx Pharma. Lipid profiles are a panel of blood tests that serve as an initial broad medical screening tool for abnormalities in lipids, such as cholesterol and triglycerides.

Indeed, the dual-listed company says its medical food product has carved out a niche, for the dietary management of patients with cardiovascular disease that are deficient in Omega-3 fatty acids - a much broader market than for Lovaza, the first prescription Omega-3 to market, after which Vascazen followed. Lovaza, which is owned by GlaxoSmithKline, is indicated exclusively for the reduction of "very high" - 500 mg/DL- triglyceride levels in adults. For 2012, GlaxoSmithKline reported worldwide Lovaza sales of $1.4 billion, up from $876 million in 2011.

"Competition from prescription and over-the-counter Omega-3 products will be formidable but Pivotal could replicate, at least in part, the market gains achieved by an earlier Omega-3 prescription product. Vascazen is broadly indicated for cardiovascular disease and clinical data suggests that it is as effective, perhaps more so, than two other prescription Omega-3 products," the Taglich analyst wrote in his report.

"A large and arguably under-medicated (for Omega-3 deficiency) patient population could, even at nominal penetration rates, underlie significant revenue upside for Vascazen within a few years of commercialization," he adds.

Indeed, by 2017, the analyst expects revenue should ramp up to around $61 million, with the company anticipated to be cash flow positive by late this year. Supported by FDA-approved material suppliers and contract manufacturers, as well as selling organizations, the company started U.S. distribution in the second quarter of 2012.

Increases in the number of sales field representatives, penetration of cardiology practices, and a rise in the average number of prescriptions written by cardiologists will drive revenue growth momentum in 2013, the Taglich analyst predicts, increasing sales to an estimated $4 million.

Quick growth is not unprecedented for the company. Pivotal was founded by veteran healthcare execs Dr. Jackowski, Eugene Bortoluzzi and Rachelle MacSweeney in October 2010, with the team already able to finance the start of its commercialization plan for Vascazen in 2011.

Earlier this month, the company said it met the primary endpoint in its "Reveal" trial, which was to correct an Omega-3 deficiency in patients with one or more risk factors associated with cardiovascular disease. The data, says Dr. Jackowski, represents a significant milestone as a treatment option for "thousands of people who are Omega-3 deficient and suffer from elevated triglycerides yet remain below the threshold of 'very high' triglycerides required for treatment with currently available prescription medications."

The randomized, double-blind, placebo-controlled study enrolled 110 patients, and also saw Vascazen achieve "statistical significance" in various secondary endpoints, including positive effects on lipid profiles.

The top-line data has been attracting much attention, and has even been accepted for presentation at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions (ATVB) at Lake Buena Vista, Florida, in May.

In another open label study, prior to taking Vascazen, 84 per cent of the 143 participants were Omega-3 deficient, and after taking the prescription product for only six weeks, only 13 per cent of the patients were still deficient, according to the results, with "lipid profiles approaching normality" after only eight weeks.

The company is also using a companion diagnostic with Vascazen to assist in the identification of individuals deficient in EPA and DHA fatty acids, with the test fully reimbursable, it says.

The medical food, which avoided the lengthy FDA pre-approval process that is required with drugs, is available with a prescription in all major pharmacies throughout the U.S. It is also just the first of a range of proven formulations that Pivotal is considering taking to market, while avoiding the costly regulatory review to which prescription drugs are subject.

For Vascazen, the company is in discussions to expand sales internationally, particularly in Europe and the Far East, where cardiovascular disease is "running rampant," affirms Dr. Jackowski.

Pivotal has in fact already been approached about commercializing the prescription product in those regions. Currently, the product is available throughout the U.S., however, its sales reps are focused on the eastern seaboard, where the CSO says the company is seeing "very good data in terms of revenue per sales rep". According to recent stats, this region contains the highest prevalence of cardiovascular disease-related illness in the nation.

With plans to close a financing for some $5 million in proceeds, the company says it can build out its dedicated sales force to more than 35 people. Its sales reps are compensated "heavily on commission", which the company says drives sales and higher volumes.

To help even more with its efforts, Pivotal launched a Co-Pay assistance program last August, and is seeing "excellent" third party payor coverage - which Dr. Jackowski says is continually growing.

The CSO says the company, which is aiming to eventually upgrade to a Nasdaq listing, is also looking at other products internally, specifically at a drug indication for stabilizing plaque, with the idea to be able to eradicate the development of a heart attack by clots.

"We believe that Pivotal's novel approach of addressing and correcting an Omega-3 deficiency will become an important part of managing cardiovascular patients. We always seem to be at the leading edge," he concludes, also referring to the rapid-format cardiac testing he developed 30 years ago to identify individuals presenting with chest pain to the emergency room, which is commonly known as the "cardiac enzymes".

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.