The Medicines Company Authorizes Generic Launch of ANGIOMAX® (bivalirudin)

PARSIPPANY, N.J., The Medicines Company today announced an agreement with Sandoz Inc. for the distribution of an authorized generic of ANGIOMAX® (bivalirudin) for injection in the United States.

“Bivalirudin has become a foundation anti-thrombin for patients undergoing PCI under The Medicines Company’s fifteen-year leadership in the cath lab,” said Glenn Sblendorio, President and Chief Financial Officer, The Medicines Company. “This agreement with Sandoz, itself a leader in the generics market, helps to ensure that bivalirudin remains a high quality product in this market. With the imminent launch of KENGREAL™ (cangrelor), our intravenous P2Y₁₂inhibitor, we look forward to advancing patient care in the cath lab for years to come.”

About ANGIOMAX® (bivalirudin) for Injection
ANGIOMAX is indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, ANGIOMAX is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). ANGIOMAX is intended for use with aspirin. ANGIOMAX® is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.

Important Safety Information
An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of ANGIOMAX administration. ANGIOMAX should be used with caution in patients with disease states associated with an increased risk of bleeding.

In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of ANGIOMAX. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components.

In clinical trials comparing ANGIOMAX and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever.

About KENGREAL™ (cangrelor) for Injection
KENGREAL is a P2Y₁₂ platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y₁₂ platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Important Safety Information
KENGREAL is contraindicated in patients with significant active bleeding.

KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product.

Drugs that inhibit platelet P2Y₁₂ function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL than with clopidogrel. Bleeding complications with KENGREAL were consistent across a variety of clinically important subgroups. Once KENGREAL is discontinued, there is no antiplatelet effect after an hour. The most common adverse reaction is bleeding.

Source: The Medicines Company