|AstraZeneca and The Medicines Company Announce Global Collaboration in Acute Ischemic Heart Disease|
WILMINGTON, Del. & PARSIPPANY, N.J., Apr 25, 2012 (BUSINESS WIRE) --AstraZeneca (NYSE: AZN) and The Medicines Company (NASDAQ: MDCO) announced today a global collaboration for acute ischemic heart disease compounds. The first part of this collaboration is a US co-promotion for AstraZeneca's oral antiplatelet medicine BRILINTA(R) (ticagrelor) tablets. Under the terms of the co-promotion agreement, The Medicines Company sales force will begin supporting BRILINTA in May 2012. This will complement the AstraZeneca sales team's promotion of BRILINTA to US hospital customers and practitioners whose patients with acute coronary syndrome (ACS) may benefit from this important therapy.
"The Medicines Company is a respected organization with a strong network in interventional cardiology," said Lisa Schoenberg, Vice President, US Sales and Marketing, Growth Portfolio, AstraZeneca. "We have laid the groundwork for BRILINTA in the US with strong managed market access as well as hospital formulary and protocol access such that now is the right time to bring this important medicine to more patients with ACS through additional support in the acute setting."
Under the terms of the global collaboration, a joint development committee and a joint commercialization committee have been established to prepare and deliver global development and commercialization plans related to AstraZeneca's BRILINTA and The Medicines Company's Angiomax(R) (bivalirudin) for injection and cangrelor, which is in development as an acute intravenous antiplatelet agent. Implementation of these plans is subject to further agreements between both parties.
The agreement also outlines terms for the four-year US BRILINTA co-promotion agreement in which AstraZeneca will pay The Medicines Company $15 million per year for performing pre-agreed commercialization activities with up to an additional $5 million per year paid if performance thresholds are met.
"Our goal in joining this global collaboration with AstraZeneca is to help improve patient care with a comprehensive suite of solutions for acute ischemic heart disease," said Brent Furse, Senior Vice President and Chief Customer Officer of The Medicines Company. "This opportunity aligns with our vision to lead in acute, intensive care hospital medicine globally."
BRILINTA is the first and only oral antiplatelet FDA-approved to significantly reduce cardiovascular (CV) death vs clopidogrel in patients with ACS. The FDA-approved label describes the efficacy and safety of BRILINTA, as compared to clopidogrel.
BRILINTA is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.
BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
BRILINTA is an important advance for patients with ACS and physicians, as it is a more effective treatment than clopidogrel, to reduce the rate of heart attack and CV death. BRILINTA is approved to be used with low-dose aspirin.
In February 2012, the American College of Chest Physicians (ACCP) updated its guidelines on Antithrombotic Therapy and Prevention of Thrombosis to include a recommendation for giving BRILINTA with low-dose aspirin to patients in the first year after an ACS. This is the first time that clinical treatment guidelines in the US have specifically suggested use of BRILINTA over clopidogrel.
In November 2011, a combined expert committee from American College of Cardiology Foundation (ACCF), the American Heart Association (AHA) and the Society for Cardiovascular Angiography and Interventions (SCAI) updated its guidelines for the management of patients undergoing percutaneous coronary intervention (PCI), to provide a Class I recommendation for giving BRILINTA to patients undergoing PCI with stenting. A Class I recommendation is the highest recommendation provided by the guidelines committee and is defined as a "procedure/treatment that should be performed/administered" to patients, given it was found to be "useful/effective/beneficial." Additionally, AHA/ACCF also revised their Guidelines on Secondary Prevention and Risk Reduction Therapy to include BRILINTA, in combination with low-dose aspirin to be taken twice daily for at least 12 months in patients receiving a bare-metal stent (BMS) or drug-eluting stent (DES) during PCI for ACS.
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA
WARNING: BLEEDING RISK
WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
WARNINGS AND PRECAUTIONS
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
NOTES TO EDITORS
About BRILINTA(R) (ticagrelor) tablets
BRILINTA is an oral antiplatelet treatment for ACS. BRILINTA is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.
BRILINTA is available in 90-mg tablets to be administered with a single 180-mg oral loading dose (two 90-mg tablets) followed by a twice daily, 90-mg maintenance dose. Following an initial loading dose of aspirin, BRILINTA should be used with a maintenance dose of 75 mg - 100 mg aspirin once daily, 81-mg aspirin dose in the US. BRILINTA is a registered trademark of the AstraZeneca group of companies.
PLATO (PLATelet Inhibition and Patient Outcomes) was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of BRILINTA versus clopidogrel, both given in combination with aspirin and other standard therapy. The study was designed to establish whether BRILINTA could achieve a clinically meaningful reduction in cardiovascular (CV) events in patients with ACS, above and beyond that afforded by clopidogrel. Patients were treated for at least 6 months and up to 12 months.
PLATO demonstrated that treatment with BRILINTA led to a significantly greater reduction in the primary end point - a composite of CV death, MI, or stroke - compared to patients who received clopidogrel (9.8% vs 11.7% at 12 months; 1.9% absolute risk reduction [ARR]; 16% relative risk reduction [RRR]; 95% CI, 0.77 to 0.92; P<0.001). The difference in treatments was driven by CV death and MI with no difference in stroke. In PLATO, the absolute difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continued to diverge throughout the 12-month treatment period.
The PLATO study also demonstrated that treatment with BRILINTA for 12 months was associated with a 21% RRR in CV death (4% vs 5.1%; 1.1% ARR; P=0.001) and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs 6.9%; 1.1% ARR; P<0.005).
The primary safety end point in the PLATO study was Total Major Bleeding (11.6% for BRILINTA and 11.2% for clopidogrel). In PLATO, non-CABG major + minor bleeding events were more common with BRILINTA versus clopidogrel (8.7% vs 7% respectively). The rate of non-CABG-related major bleeding was higher for BRILINTA (4.5%) vs clopidogrel (3.8%).
Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients treated with clopidogrel. Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment.
About Acute Coronary Syndrome (ACS)
ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (UA), non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI).
About Angiomax (bivalirudin) for injection
Angiomax (bivalirudin) is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life.
In the United States, Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) is indicated for use in patients undergoing angioplasty, also called percutaneous coronary intervention (PCI), and in patients with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with unstable angina (UA) undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in ACS patients not undergoing PCI or PTCA.
Important Safety Information for Angiomax (bivalirudin) for injection
Angiomax (bivalirudin) is contraindicated in patients with active major bleeding or hypersensitivity (e.g., anaphylaxis) to Angiomax or its components. Hemorrhage can occur at any site. 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. The most common adverse reaction for Angiomax was bleeding (28%). Other adverse reactions (>0.5%) for Angiomax were headache, thrombocytopenia, and fever. 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. Please see full prescribing information available at http://www.angiomax.com.
Cangrelor is an investigational intravenous small molecule antiplatelet agent not approved for commercial use in any market. Cangrelor was exclusively licensed in December 2003 by The Medicines Company from AstraZeneca.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
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About The Medicines Company
The Medicines Company 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.
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," "plans" 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 the Company's products will advance into clinical trials or through the clinical trials process on a timely basis or at all, whether results of preclinical studies and clinical trials such as the results described above will be indicative of results in later clinical trials, 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 Annual Report on Form 10-K filed on February 29, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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