By: Dylan Sikes - AllPennyStocks.com News

Friday, October 11, 2013

Thrombotic cardiovascular events present a significant risk to heart patients, providing for several blockbuster blood-thinning drugs to emerge in recent years. In 2012, the race to produce new drugs in this area stepped it up a notch with the expiration of the patents on Sanofi and Bristol-Myers Squibb’s heavily used Plavix. When Plavix went off patent, it put pressure on other blood thinning drugs, such as Eli Lilly’s (NYSE:LLY) Effient, AstraZeneca’s (NYSE:AZN) Brilinta and Medicure Inc.’s (TSX-Venture:MPH) (OTCQB:MCUJF) Aggrastat as payers looked for patients to start using cheaper generics. A smaller specialty pharmaceutical company, Winnipeg, Manitoba-based Medicure markets Aggrastat (tirofiban) in the United States, while Correvio International has license for the rest of the world.

Aggrastat, an injectable antiplatelet drug approved in combination with heparin, is indicated for the treatment of acute coronary syndrome. Clinical data showed the cocktail of Aggrastat and heparin to lower the risk of myocardial infarction and death by 43 percent compared to heparin alone in the week following therapy.

The aforementioned pressures were showed in Medicure’s fiscal year ended May 31, with revenue dropping from $4.8 million in 2012 to $2.6 million and swinging to a loss of $2.1 million for the year from a profit of $9,316 a year earlier.

Medicure has said that part of the declines was attributed to wholesalers keeping fewer inventories on hand as part of a broader industry trend. The company also noted that it discounted Aggrastat to new customers while hospital demand remained consistent with the year prior, but historical customers moved to other drugs.

Medicure has been working to develop and implement a new regulatory, brand and life cycle strategy for Aggrastat to try and bolster sales. In January, the company submitted a supplemental New Drug Application (sNDA) with the Food and Drug Administration requesting the approval of a high dose bolus dosing, or HDB, regimen of Aggrastat.

In clinical studies using the HDB regimen, Aggrastat was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients across more than 30 clinical sites. The ability of the Aggrastat HDB regimen to achieve greater than 90 percent platelet aggregation inhibition within 10 minutes is seen as an important feature by interventional cardiologists in settings where rapid platelet inhibition is required for coronary intervention.

On Friday, Medicure got big news that the FDA has approved the HDB regimen, sending shares soaring ahead on the highest level of volume this year, albeit only 91,000 shares changing hands. Shares have surged by more than 100 percent to 42 cents.

"The inclusion of the contemporary, guideline-recommended dosing regimen for Aggrastat is expected to have a positive impact on sales over the coming months," said Dr. Albert D. Friesen, chief executive at Medicure, in a statement today.

Medicure has Aggrastat in clinical trials for other indications as well, in patients with impaired kidney function for example, and is developing and awaiting results from a Phase 2 clinical trial of Tardoxal for Tardive Dyskinesia, a hard-to-treat disorder involving involuntary body movements. Investors will be on the lookout for those results as well as for greater market penetration with Aggrastat given the new FDA approval that could continue to drive share value. Proper due diligence is, as always, encouraged.

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