In conversation with Pivotal Therapeutics recently sat down with the management team at Pivotal Therapeutics (OTCQX:PVTTF; CSE:PVO) to discuss the company’s VASCAZEN product that addresses Omega-3 deficiency in cardiovascular disease (CVD) patients, an under-recognized, yet highly prevalent condition. The team, including Eugene Bortoluzzi, CEO, Dr. George Jackowski, CSO, Rachelle MacSweeney, president & COO, and newly appointed CFO, Prakash Gowd, also explore clinical data supporting VASCAZEN’s use, the competition and Pivotal’s plans for commercial development.

Let’s begin with an overview of the company, Eugene.

Pivotal is an emerging specialty pharmaceutical company that specializes in Omega-3 therapies for cardiovascular health and wellbeing. Our lead product, VASCAZEN, is an FDA-regulated, patented, and highly purified formulation of Omega-3 for the management of Omega-3 deficiency in CVD patients. It is categorized by the FDA as a medical food, which means the product is specifically designed to address a nutritional deficiency and is available by prescription in the U.S., where we are focused on initiatives to increase awareness and adoption.

Why focus on Omega-3 therapies, George?

Omega-3s are essential fatty acids that cannot be produced by the body, and thus must be taken in through our diets. They have numerous beneficial effects in the body, but from a cardiovascular perspective, Omega-3 improves blood flow, reduces inflammation, and has positive effects on lipid metabolism. The two most important Omega-3s are Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA), and we wanted to develop a highly purified, prescription-grade product with the optimum ratio of EPA to DHA.

There is well-documented scientific evidence that taking Omega-3 reduces risk factors associated with CVD and reduces mortality rates in patients with CVD. According to a study published in the New England Journal of Medicine in 2002, an Omega-Score in the “low-risk” quartile is associated with an 80% lower risk of sudden death, compared with individuals with scores in the “very high risk” quartile.

Is Omega-3 deficiency a real problem, Eugene?

Yes, absolutely. There are an estimated 72 million Omega-3 deficient CVD patients in the U.S., so correcting the deficiency represents a huge unmet need. It is important to treat these CVD patients who are suffering from the sequelae of being Omega-3 deficient.

In 2005, dietary guidelines issued by the NIH showed that 70% of Americans were Omega-3 deficient. The American Heart Association recommends two-to-four grams of EPA and DHA a day, but it’s very difficult to achieve these levels. Consumers have a choice between four, easy-to-swallow VASCAZEN capsules a day that have no fish aftertaste, or up to 12 over-the-counter fish oil supplements that have lower purity and no sustained biological effect, or three fish meals a day, seven days a week, that may contain impurities and toxins, without accurately measuring the amount of Omega-3 in a meal.

We have never seen over-the-counter products achieve the level of quality control we employ in our manufacturing process. I can’t stress the importance of purity enough. Purity refers to the total Omega-3 content, and the absence of toxic contaminants.

How was VASCAZEN developed, Rachelle?

VASCAZEN acts by elevating EPA and DHA to levels associated with a reduced risk of cardiovascular complications. Three factors go into making an effective Omega-3 product – purity, a dosage of more than two grams a day and the ratio of EPA to DHA. VASCAZEN is greater than 90% pure Omega-3 and our unique formulation and proprietary 6:1 EPA to DHA ratio has the potential to provide optimal anti-inflammatory benefits and cardiac protection. Each one-gram capsule of VASCAZEN guarantees at least 680 mg of EPA and 110 mg of DHA.

VASCAZEN’s 6:1 EPA to DHA formulation is patent protected in the U.S. until 2031. The patent also covers the formulation in conjunction with anti-obesity agents for the reduction of body weight in CVD patients and diabetics. The company has patents pending on the formulation, composition and combinations with existing cardiovascular drugs around the world.

What clinical data supports the use of VASCAZEN, George?

Our REVEAL study has added credence to a decades-old notion that an Omega-3 deficiency plays a vital role in cardiovascular disease. We found that correcting an Omega-3 deficiency with VASCAZEN can reduce CVD risk factors, improve blood flow, reduce inflammation and have positive effects on lipid metabolism.

The randomized, placebo-controlled REVEAL study found that of the 655 CVD patients screened, 89% were Omega-3 deficient, which is a very significant finding. We were able to correct the Omega-3 deficiency within eight weeks of treatment, which resulted in a 48% reduction of triglycerides, a 30% reduction of very-low-density lipoprotein cholesterol and a 10% increase of HDL, or so-called good cholesterol, without adversely affecting LDL, or so-called bad cholesterol, in CVD patients with normal and high triglyceride levels. The REVEAL study has been published in the peer-reviewed journal, Molecular and Cellular Biochemistry, and has been presented at various American Heart Association scientific meetings.

In an earlier open-label study, we found that 84% of participants were Omega-3 deficient. After six weeks of treatment with VASCAZEN, only 13% of patients were still deficient in Omega-3.

What is the market potential of Omega-3 deficiency, Prakash?

GSK’s Lovaza, Amarin’s Vascepa and AstraZeneca’s Epanova, are drugs that have been approved only to treat patients with very high triglycerides, which covers only about 3.4 million individuals, or 5% of the market. We are able to address the entire Omega-3 deficient population with VASCAZEN, which focuses on correcting Omega-3 deficiency and has beneficial outcomes on CVD risk factors, including a patient’s lipid profile. Citing an estimated annual revenue potential of $1,500 per VASCAZEN prescription, penetrating 1% of the market would generate annual revenue of $1-billion, based on 72 million Omega-3 deficient CVD individuals in the U.S.

Are you working on an Omega-3 point-of-care diagnostic, George?

We are leveraging our expertise and previous success in the diagnostics field. Pivotal has established an in-house R&D group to develop a point-of-care diagnostic for Omega-3 deficiency. When it’s ready for market, it would allow for the identification of Omega-3 deficient patients right in physicians’ offices, helping them to identify the right patients, and also for use as a companion diagnostic for VASCAZEN treatment monitoring.

What is your strategy for commercial development, Rachelle?

Making VASCAZEN successful will require us to build awareness of Omega-3 deficiency in CVD patients, promote the attributes of VASCAZEN, and drive adoption of the product. We recognize the importance of expanding our sales effort, but will execute our commercial strategy in a cash-efficient manner by gradually building our internal sales force, but also by seeking out commercial partners who have an interest in promoting VASCAZEN in the U.S. Our commercial development strategy in Canada may involve us expanding through partnerships into the specialty care market with our OMAZEN product line, or into the consumer market with a lower dose over-the-counter product. We have great products, backed by solid scientific evidence, targeting a significant market opportunity, so we are very optimistic about the future.