SOURCE: The Medicines Company

The Medicines Company

July 26, 2011 20:30 ET

NICE Endorses Bivalirudin for Heart Attack Patients

Independent Health Standards Organization Recommends Bivalirudin Strategy for STEMI Patients Undergoing Primary PCI

PARSIPPANY, NJ--(Marketwire - Jul 26, 2011) - Bivalirudin (using the trade name Angiox® in Europe and Angiomax® in the United States), in combination with aspirin and clopidogrel, has been recommended by the National Institute for Health and Clinical Excellence (NICE) for the treatment of adults with ST-segment-elevation myocardial infarction (STEMI or heart attack) undergoing emergency lifesaving procedures to unblock their coronary arteries (primary percutaneous coronary intervention (PCI)). The basis of this recommendation was a review of clinical and cost efficacy data comparing the bivalirudin strategy against a strategy of heparin with glycoprotein inhibitor, in combination with aspirin and clopidogrel. Primary Care Trusts (PCTs) in England and Wales will now be encouraged to adopt the bivalirudin strategy for STEMI patients undergoing primary PCI.

In its review the Appraisal Committee noted "the robustness of the clinical data, in which treatment with bivalirudin dominated treatment with a glycoprotein IIb/IIIa inhibitor plus heparin (that is, was less costly and more effective) and that the results of the model are robust to the various sensitivity analyses." The Committee concluded that "the model is associated with a very low degree of decision uncertainty and that bivalirudin should be recommended for the treatment of adults with STEMI undergoing PCI."

Supporting the positive NICE recommendation, Professor Anthony Gershlick, Interventional Cardiologist, University Hospitals of Leicester, commented: "In carrying out primary PCI we not only have the delicate task of clearing the blockage and, hopefully, saving the heart attack patient -- we also have to deal with the concern that the life-saving anti-clotting drugs we are giving these sick patients during the procedure can potentially cause post-operative bleeding which is sometimes fatal. This is a routine concern in this type of patient."

The Medicines Company (NASDAQ: MDCO), manufacturer of bivalirudin, welcomes the decision by NICE which was made on the 'strength of evidence' for the drug. In a statement by NICE today, Dr Carole Longson, Health Technology Evaluation Centre Director said: "With the number of PCIs being carried out increasing each year, this guidance provides the NHS in England and Wales with another important tool to enable it to treat people who have had a heart attack more effectively. The independent committee that advises NICE considered that, on the basis of the available evidence, bivalirudin, in combination with clopidogrel and aspirin, is both more effective and less expensive than treatment with a glycoprotein inhibitor plus heparin. It is also associated with a lower incidence of major bleeding events compared with heparin and glycoprotein inhibitors."

The NICE Final Appraisal Determination for bivalirudin for the treatment of adults with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention has been made final today for PCT implementation. NICE noted in its report that bivalirudin is already widely in use in the UK and both patients and clinicians are supportive of its continued use.

About Angiomax® (bivalirudin) for Injection

Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to treatment with heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of one-year mortality in patients undergoing PCI.

In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. 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 is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Angiomax is not approved for use in ACS patients not undergoing PCI. Please see full prescribing information available at http://www.angiomax.com.

About Angiox® (bivalirudin)
Angiox is the trade name for bivalirudin in the European Union. In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel. Please see full prescribing information available at http://www.angiox.com.

About NICE
The National Institute for Health and Clinical Excellence (NICE) is the independent organization in England and Wales responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. NICE produces guidance on the use of new and existing medicines, treatments and procedures within the National Health Service (NHS) in England and Wales. NICE technology appraisal recommendations are prepared by independent advisory committees called Technology Appraisal Committees. The NHS is required to provide funding and resources for medicines and treatments recommended by NICE through its single and multiple technology appraisal processes.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.

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