As a complement to its lead cardiovascular drug, MC-1, Medicure Inc. acquired rights to its first marketed product, Aggrastat, a glycoprotein IIb/IIIa inhibitor to treat acute coronary syndrome.

Taking over all U.S. sales responsibilities from MGI Pharma Inc. means Winnipeg, Manitoba-based Medicure will have its own contracted sales force and begin to post its first revenues since its 1997 founding.

"It's a perfect fit with the strategic goal of getting a product that is complementary to our lead drug, MC-1, in the acute cardiovascular space," said Albert Friesen, Medicure's president and CEO. "So the target market is one that we are developing with an existing drug."

Terms call for Medicure to pay MGI Pharma $19 million on top of fees for existing inventory. Developer Merck & Co. Inc., of Whitehouse Station, N.J., also is entitled to royalties on the net sales of Aggrastat in the U.S. The royalties are "a sliding scale starting at 5 percent for sales up to $28 million," Friesen told BioWorld Today, "and up to 20 percent for sales over $100 million a year."

Medicure is financing the acquisition through a senior secured term loan of $15.8 million, which is repayable over 42 months. Lenders include Merrill Lynch Capital, Silicon Valley Bank and Oxford Finance Corp.

Another aspect of Medicure's acquisition of Aggrastat entails a right of first refusal option for Merck. The pharmaceutical company gets first dibs on all ex-North American rights to products combining MC-1 with Aggrastat.

Medicure, however, retains rights to partner MC-1 everywhere as a stand-alone product.

"The focus of the existing agreement [with Merck] is solely for the combination drug of MC-1 and Aggrastat and only for the market outside the U.S.," Friesen said, adding that Aggrastat targets platelet aggregation, while MC-1 is a cardioprotectant, so "together, they provide additive benefits to the patients."

MC-1 is expected to begin a pivotal Phase III study later this year. It is designed to reduce ischemic reperfusion injury in patients undergoing coronary artery bypass graft (CABG) surgery, while Aggrastat is used to treat acute coronary syndrome, including unstable angina and non-Q-wave myocardial infarction.

Launched in the U.S. in 1998, Aggrastat (tirofiban hydrochloride) has had modest sales because it has lacked a sustained sales support the past several years. In 2005, it brought in $10.9 million in the U.S., while total sales for the GP IIb/IIIa inhibitor class that year were more than $450 million.

"The drug has a very small market share in a very big market," Friesen said, "so we believe there is an opportunity to grow."

The company has not given guidance on increasing Aggrastat's sales, but the product reached $100 million in sales in 2000 when Merck was promoting it.

Medicure is contracting a sales force of about 15 representatives. There has been "no sales or marketing effort placed on the drug" in recent years, Friesen said, explaining why sales have declined. He added that a terminated angioplasty trial also negatively affected clinicians' attitude toward the drug, but Medicure plans to relaunch Aggrastat with the support of key opinion leaders in the space.

Clinical data have demonstrated that Aggrastat added to standard therapy reduced by 66 percent the incidence of death and myocardial infarction at 48 hours, reduced it by 43 percent at seven days, and reduced it by 30 percent at 30 days.

"We'll have a dedicated sales and marketing program, which will be on the ground providing the product in early October," Friesen said.

With an approval of MC-1 expected by the end of 2008, Medicure will have about two years of sales and marketing experience before launching its second cardiovascular product. The company, however, is discussing partnering MC-1 globally in a deal that could include co-promotion rights. Pricing of MC-1 is expected to be between $600 to $1,000 per course of treatment. With about 500,000 CABG procedures a year in the U.S., the potential sales for that indication is up to about $500 million, "and then the world market would be about double that," Friesen said. "The ACS market is about three times the size."

Outside of the U.S., Aggrastat is marketed by Merck, which licensed U.S. rights to Baltimore-based Guilford Pharmaceuticals Inc. for $84 million in 2003. (See BioWorld Today, Oct. 30, 2003.)

Guilford was acquired last year for $177.5 million by Minneapolis-based MGI Pharma, whose main interest was its cancer programs, explaining the decision to sell Aggrastat rights to Medicure. (See BioWorld Today, July 22, 2005.)

In Europe, sales of Aggrastat reached $88 million in 2005. The product is available in 82 countries.

Medicure's stock (AMEX:MCU) rose 2 cents Wednesday to close at $1.52. MGI's stock (NASDAQ:MOGN) rose 8 cents, ending the day at $13.55.