-Approval based on landmark HORIZONS-AMI trial data-
PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI). The basis of this approval is the landmark HORIZONS-AMI study which was the first drug trial to demonstrate a reduction in deaths from heart attacks in patients undergoing emergency PCI. The trial showed that patients treated with Angiox compared with today's leading treatment - heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) - were more likely to survive and had less frequent severe bleeds.
Professeur Ph. Gabriel Steg, from Centre Hôpitalier Bichat in Paris, France commented that "The sustained reduction in all-cause and cardiovascular mortality achieved by bivalirudin in the context of primary PCI, compared to the standard of care, provides a compelling case for switching to bivalirudin as the preferred anticoagulant for primary PCI."
The HORIZONS-AMI Trial
The HORIZONS-AMI trial compared Angiox to heparin plus a GPI in 3,602 patients (57 percent of whom were recruited in Europe) presenting with the most severe form of heart attack, known as STEMI, undergoing a emergency (primary) PCI.
Results at 30 days showed that Angiox:
- Significantly improved overall mortality including a reduction in the incidence of heart-related deaths by 38 percent (1.8% vs. 2.9%, p=0.03)
- Significantly reduced the incidence of major bleeding by 42 percent (5.1% vs. 8.8%, p< 0.0001).
- Significantly reduced the incidence of net adverse clinical events, a composite of major adverse cardiac events or major bleeding, by 26 percent (9.3% vs. 12.7%, p = 0.0015).
- Demonstrated comparable rates of major adverse cardiac events (5.4% vs. 5.5%, p = 0.8901).
Long terms results of the HORIZONS-AMI data have been published recently - including one-year data recently published in The Lancet, and two-year data, recently presented at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference, confirm the 30-day mortality benefit showing a significant 38 percent reduction in cardiac mortality at 30 days, which was maintained at 43 percent (at one year) and 41 percent (at two years).
"The HORIZONS-AMI trial confirms the role of Angiox as an alternative anticoagulant strategy to treat patients with acute myocardial infarction undergoing primary PCI. The safety benefit observed with bivalirudin against unfractionated heparin + GPIIb/IIIa inhibitors is a real contribution to interventional cardiology in the contemporary era of evidence based medicine" said Professor Gilles Montalescot of the Pitié-Salpêtrière Hôpital, France.
Previous studies have shown an association between reduced major bleeding in angioplasty patients with greater long-term survival. More than 27,000 patients have been studied in clinical trials involving bivalirudin to date. Treatment with Angiox has resulted in less bleeding and similar rates of composite ischaemia compared to heparin plus GPI in patients undergoing angioplasty for stable angina, unstable angina and non-ST-elevation myocardial infarction (NSTEMI).
About ST-Segment Elevation Myocardial Infarction (STEMI)
STEMI is the most severe type of heart attack and carries a substantial risk of death and disability. STEMI involves myocardial injury, indicated by significant abnormalities on electrocardiogram called ST-segment elevations. Guidelines recommend that for patients with STEMI, early mechanical or pharmacological reperfusion should be performed to help prevent further heart damage. In the EU, an estimated 1 million PCI procedures are performed each year, of which 150,000 are primary PCI's for the treatment of patients with STEMI.
STEMI is part of a spectrum of acute coronary syndromes (ACS) caused by acute exacerbation of underlying coronary artery disease. ACS also includes non-ST elevation myocardial infarction (NSTEMI) and unstable angina (UA). NSTEMI is typically caused by partial obstruction of a coronary artery that results in some damage to heart muscle. UA is chest pain at rest or upon exertion, due to ischaemia. Stable angina is characterised by predictable chest pain during exertion that resolves at rest, and is not considered a form of ACS.
About Angiox
Angiox is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25 minute half-life. In clinical trials, treatment with Angiox resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to 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.
Angiox is currently approved for use in Europe as an anticoagulant in adult patients undergoing PCI and for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel.
The most common adverse events for Angiox in clinical trials are bleeding and bleeding related events. Any unexplained fall in blood pressure or haematocrit, should lead to serious consideration of a hemorrhagic event and cessation of Angiox administration. Please see full prescribing information available at www.angiox.com.
Angiox is marketed as Angiomax in the USA and other territories.
About The Medicines Company
The Medicines Company (Nasdaq: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiox® (bivalirudin) in Europe for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart and as a treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI)) planned for urgent or early intervention when used with aspirin and clopidogrel. The Company's Web site is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether we receive regulatory approval for additional indications, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 10, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contacts
WeissComm Partners
Kim Gorode
Phone: (+1 212) 257-6737
kgorode@wcpglobal.com
or
The Medicines Company
Robyn Brown
Phone: (+1 973) 290-6000
investor.relations@themedco.com