Medicure Inc., a cardiovascular focused biopharmaceutical company, announced that the company has acquired the exclusive US rights to Aggrastat Injection (tirofiban hydrochloride) from MGI Pharma, Inc.
Aggrastat, a glycoprotein (GP) IIb/IIIa inhibitor, is used for the treatment of acute coronary syndrome (ACS) including unstable angina and non-Q-wave myocardial infarction.
Developed by Merck & Co., Inc., Aggrastat was launched in the US in 1998, and is currently available in 82 countries worldwide. Merck continues to market Aggrastat outside the US, including Europe where 2005 sales for Aggrastat were approximately US$88 million. Merck sold the US rights of Aggrastat to Guilford Pharmaceuticals Inc. in 2003, which was subsequently acquired by MGI Pharma in 2005. Total US sales for the GP IIb/IIIa inhibitor class in 2005 were in excess of US$450 million, of which Aggrastat sales comprised US$10.9 million.
"The acquisition of Aggrastat fits strategically with Medicure's goal of building a world class cardiovascular business from drug discovery through to commercialization," commented Medicure's President and CEO, Albert D. Friesen, PhD. "This acquisition enables us to build an acute cardiovascular sales team that will support our immediate needs for Aggrastat and also our future needs for MC-1, our lead clinical product."
Under the terms of the agreement Medicure will pay MGI Pharma US$19 million plus the purchase of existing inventory, and will make certain royalty payments to Merck based on net sales of Aggrastat in the US. To finance the acquisition, the company entered into a senior secured term loan totalling US$15.84 million, repayable over 42 months, with a syndicate of lenders, led by Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., and including Silicon Valley Bank and Oxford Finance Corporation.
In addition, Merck has acquired the non-North American right of first refusal on future product opportunities combining MC-1 with Aggrastat. MC-1, Medicure's lead cardioprotective product, is expected to begin a pivotal phase III study later this year as a treatment to reduce ischemic reperfusion injury in patients undergoing coronary artery bypass graft (CABG) surgery.
"We believe that the participation of these experienced financial institutions represents a significant endorsement of this strategic acquisition and Medicure's portfolio of cardiovascular products," continued Dr. Friesen. "In addition, this acquisition further increases the value of MC-1. We see a market opportunity in combining Aggrastat with MC-1 for specific cardiovascular applications, and will continue to advance partnering discussions related to this product opportunity. Furthermore the right of first refusal is exclusively focused on the combination of MC-1 and Aggrastat and in no way restricts our ability to develop and partner MC-1 or any other MC-1 combination product."
Pierre Theroux, MD, Professor of Medicine at the University of Montreal and Cardiologist at the Montreal Heart Institute stated, "I had the privilege to lead the PRISM-PLUS trial, which was the first large trial ever done to test the efficacy of upfront use of a GP IIb/IIIa inhibitor in a high-risk ACS population. The trial demonstrated that tirofiban (Aggrastat) added to standard therapy reduced the incidence of death and myocardial infarction at 48 hours (66 per cent reduction), 7 days (43 per cent reduction) and 30 days (30 per cent reduction). Importantly, the observed benefits applied to medically managed patients and to patients referred for percutaneous intervention (PCI) or CABG surgery as well. The current ACC/AHA guidelines also give a strong recommendation for the use of GP IIb/IIIa inhibitors for high-risk PCI."
"There are a number of significant benefits to Medicure resulting from this acquisition," commented Medicure's vice president, Market and Business Development, Moray Merchant. "Aggrastat gives the company immediate revenues; it is a product with considerable sales growth potential given its lack of sustained sales support for the past several years; and it allows us to commercially leverage the excellent relationships we have already established with leading acute cardiovascular centres in the US through our MC-1 clinical development."