Development Programs

The Medicines Company is conducting several development programs with planned and executed clinical trials.

The Medicines Company believes Angiomax will become the leading replacement for heparin in acute cardiovascular care. Heparin, an indirect thrombin inhibitor and commonly used anticoagulant, was discovered almost 100 years ago. Across studies in angioplasty, Angiomax has been shown to be better than heparin in preventing bleeding and ischemic complications such as heart attack, which are associated with angioplasty procedures.

Definition of terms:

• PCI: percutaneous coronary intervention is a general term used to describe non-surgical revascularization procedures of the coronary arteries.
• HITTS: heparin-induced thrombocytopenia and thrombosis syndrome (an allergic-like reaction to heparin)
• ACS: acute coronary syndromes, such as heart attack
• CABG: coronary artery bypass graft surgery (commonly called bypass or "open-heart" surgery)
• Neonates: prematurely born babies with active thrombosis (clotting)

Angiomax is an anticoagulant currently approved in the United States and other countries for use in patients undergoing coronary angioplasty procedures. The Medicines Company is conducting several clinical trials to study potential additional indications and to establish a clearer clinical basis for Angiomax use.

Background information on Angiomax...

Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials involving 1,406 patients medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (>2%) seen with Cleviprex are headache, nausea and vomiting.

Please see full prescribing information available at www.cleviprex.com

Cangrelor is a short-acting injectable platelet inhibitor agent that prevents the aggregation of platelets in the clotting process. The Medicines Company believes that cangrelor may fit into its hospital acute care product portfolio because of potential uses in the cardiac catheterization laboratory and the operating room. Cangrelor is an investigational agent not yet approved by the FDA.

Cangrelor acts directly on the P2Y12 platelet receptor, a clinically validated target to treat or prevent arterial thrombosis by acting on a specific, well studied, enzyme pathway known as ADP. There is currently no short-acting, intravenous P2Y12 antagonist approved for acute patient care. In the cardiac catheterization laboratory, the use of platelet inhibitors that block activation is considered important therapy because of several studies of oral platelet inhibitors that have demonstrated better patient outcomes when these agents are administered before coronary angioplasty.