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Pivotal Therapeutics Vascazen Marketing Program Picks Up Pace As Sales Climb

Pivotal Therapeutics (OTCQX:PVTTF) (CNSX:PVO), a specialty pharmaceutical company focused on Omega-3 therapies for cardiovascular disease (NYSE:CVD), has narrowed its first quarter losses as the company's marketing program for its Vascazen product picks up momentum.

For the three months to March 31, the company reported a loss of $0.78 million, or 1 cent per share, compared with a loss of $0.83 million, or 1 cent per share, in the year-ago period.

Sales jumped to $73,642 from $3,322 a year earlier, leading to higher cost of sales of $28,379 from $1,734 in the first quarter of 2012. Total expenses were roughly on par with the year-ago period at $0.83 million.

"Our pilot marketing program for VASCAZEN continues to gain traction, with initial sales up more than 200% from the previous quarter," said CEO and CFO Eugene Bortoluzzi, in a statement released with the quarterly figures.

"Furthermore, the pilot program continues to provide valuable information which we are incorporating into our plans for our full launch of VASCAZEN in 2013."

The company's 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 says are ideal, and cannot be achieved just through simple changes in diet alone.

Vascazen, 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. Currently, the company's sales reps are focused on the eastern seaboard in the U.S., which it says contains the highest prevalence of cardiovascular disease-related illness in the nation.

"After presenting our positive results from our recently concluded VASCAZEN-REVEAL clinical trial, healthcare professionals are realizing the benefits of Vascazen and how treating an Omega-3 deficiency can address risk factors for cardiovascular patients," said Bortoluzzi.

Pivotal earlier this month revealed that results from a clinical trial showed that its Vascazen product was highly effective in correcting an Omega-3 deficiency. Indeed, after eight weeks of treatment, the company said a "statistically significant" increase of 121 per cent in the Omega-Score and 112 per cent in the Omega-Index - both diagnostic tests that measure circulating blood levels of Omega-3 in individuals - was seen in the Vascazen-treated subjects. Pivotal also said that the trial showed that secondary goals, such as a 48 per cent triglyceride reduction, exceeded company expectations.

The pharmaceutical company's results generated buzz, as they were presented at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions.

Looking ahead for the remainder of this year, Pivotal says it will advance the commercialization of its product, with a full launch in the U.S. as it expands its sales and marketing team.

The company is also looking to start new clinical trials and expand its intellectual property portfolio, armed with a strong management team. Its chairman and chief scientific officer is Dr. George Jackowski, who was earlier this year awarded the Queen Elizabeth II Diamond Jubilee Medal for his contributions to the Canadian biotech and pharmaceutical industries. He is credited for the development of the rapid format cardiac blood test - the standard of care for triaging patients presented to the emergency room with chest pain.

At the end of the first quarter, the company, which is expected to hold its annual general meeting of shareholders on June 26, had working capital of $0.49 million.

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