The Medicines Company Announces Positive Phase III Data in Two Late-Breakers at AHA and in NEJM
Data from Two International Trials with nearly 14,000 Patients Presented at American Heart Association Scientific Sessions and Published in Two Papers in the New England Journal of Medicine
Parsippany, N.J., November 15, 2009—The Medicines Company (NASDAQ: MDCO) today announced the data from 13,941 patients treated in the discontinued CHAMPION Phase III program of cangrelor. While cangrelor did not show superiority to 600 mg clopidogrel given orally for the pre-specified primary endpoint comprising death, MI, or ischemia driven revascularization (IDR) at 48 hours, full analysis of the CHAMPION program data revealed strong evidence of pharmacological effects, clinical effectiveness and suitable safety in patients undergoing percutaneous coronary intervention (PCI). In fact, cangrelor significantly reduced the composite endpoint of death, Q-wave myocardial infarction (MI) and IDR.
Two separate presentations on the results of the CHAMPION PCI and CHAMPION PLATFORM trials will be given today at the American Heart Association Scientific Sessions 2009 in Orlando, Florida, by Robert A. Harrington, M.D., Professor of Medicine at Duke University Medical Center, Director of the Duke Clinical Research Institute and Deepak L. Bhatt, M.D., M.P.H., Chief of Cardiology at the VA Boston Healthcare System, Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and the VA Boston Healthcare System. The speakers are the lead authors of two papers on these results published in the New England Journal of Medicine, which became available online today.
CHAMPION program data were analyzed after the program’s discontinuation in May 2009 when 98% of targeted patients in CHAMPION PCI and 84% in CHAMPION PLATFORM had been enrolled. At that time, the program's independent interim analysis review committee reported to the company and the principal investigators that the CHAMPION PLATFORM trial was not expected to meet its primary endpoints. Cangrelor was superior to clopidogrel (600 mg given orally before PCI) in inhibiting platelet aggregation measured by a range of laboratory tests (p-value <0.0001) during the first 2 hours of treatment, resulting in more rapid and greater effect than that of clopidogrel. The antiplatelet effects of cangrelor are quickly reversible, enabling smooth transition to oral clopidogrel with no evidence of attenuation of clopidogrel effect.
The risk of the composite endpoint of death, Q-wave MI or IDR was 39% lower on cangrelor than on 600 mg clopidogrel given immediately before or immediately after PCI (p-value = 0.0049). Similarly, the risk of the composite endpoint of death, Q-wave MI or stent thrombosis was 45% lower (p-value = 0.0028).
In CHAMPION PCI, cangrelor was not superior to 600 mg clopidogrel loading dose in the 37% of patients who entered the trial on clopidogrel maintenance therapy. However, cangrelor was superior to a 600 mg clopidogrel loading dose in remaining 63% thienopyridine-naïve patients with a relative risk reduction for death/Q-MI/IDR of 43% (p-value = 0.04). In CHAMPION PLATFORM, all patients were thienopyridine-naïve and cangrelor showed a relative risk reduction for death/Q-MI/IDR of 45% (p-value = 0.0028).
“Although these endpoints were a pre-specified component of the primary endpoint, their combinations were devised post-hoc and so the data cannot be deemed conclusive,” said Deepak L. Bhatt, M.D., M.P.H “But these findings are biologically plausible and suggest superior antiplatelet effects and clinical potential.”
"The platelet sub-study of the CHAMPION PCI trial provides evidence of rapid, potent antiplatelet effect,” said Robert A. Harrington, M.D. “This is particularly important in specific patient groups, such as those urgently requiring PCI or surgery, those who cannot receive oral medication, those who are known not to respond well to clopidogrel.”
There was no significant increase with cangrelor in usual measures of bleeding, including no increase in TIMI major or minor bleeding; no increase in GUSTO severe or moderate bleeding; and no increase in the incidence of blood product transfusions. Access site hematomas were more frequent in patients on cangrelor than on comparators. Infrequent (~1%) and reversible episodes of breathlessness were also reported more frequently among patients given cangrelor.
Cangrelor is uniquely positioned in the hospital setting where patients require rapid onset, direct and rapidly reversible platelet inhibition. This may translate into important advantages for patients undergoing PCI, patients undergoing other procedures and those with conditions associated with arterial thrombosis such as acute coronary syndromes.
“We are very excited by cangrelor’s promising pharmacological data, substantial improvement of important clinical endpoints, and suitable safety. It is important that cangrelor was superior to a 600 mg clopidogrel loading dose in thienopyridine-naïve patients. Our market research and CHAMPION PCI data show that this is the majority of patients undergoing PCI,” stated Clive Meanwell, M.D., PhD, Chief Executive Officer of The Medicines Company. “We intend to continue our dialogue with the FDA and initiate discussions with European regulators to devise the most efficient and expeditious development path forward. We will be able to plan additional large clinical studies as well as timelines for cangrelor reaching the market after completing discussions with the regulators. In the meantime, we will commit resources to regulatory submissions and preparation of commercial-scale manufacturing. “
The company will continue enrolment in the BRIDGE study – a trial testing cangrelor as a platelet inhibitor in patients with coronary stents who need to discontinue clopidogrel prior to planned surgery. The company also will initiate various other clinical pharmacology studies.
In summary, the pharmacological effects, clinical effectiveness and suitable safety of cangrelor make this a highly attractive drug candidate for short-term platelet inhibition in hospital patients. The compound is a valuable asset, and the Company remains committed to its further development.
Cangrelor is an investigational intravenous antiplatelet agent exclusively licensed in December 2003 from AstraZeneca.
The Medicines Company will host a conference call tomorrow, Monday, November 16, 2009 at 8:30 a.m. Eastern Time. The conference call will be available via phone and webcast. The dial in information is listed below:
Domestic Dial In: 866-700-7441
International Dial In: 617-213-8839
Passcode for both dial in numbers: 59976774
Replay is available from 11:30 a.m. Eastern Time following the conference call through November 23, 2009. To hear a replay of the call, dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 10591724.
This call is being webcast and can be accessed at The Medicines Company’s website at www.themedicinescompany.com<http://click.icptrack.com/icp/relay.php?r=16869452&msgid=161123&act=5ZJE&c=586627&admin=0&destination=http%3A%2F%2Fus.lrd.yahoo.com%2F_ylt%3DArnj0IbanqAVvSI.HvqmC4uliRkC%2FSIG%3D1183uqpii%2F%2A%2Ahttp%253A%2Fwww.themedicinescompany.com%2F>.
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 Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex®(clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Medicines Company's website is www.themedicinescompany.com<http://click.icptrack.com/icp/relay.php?r=16869452&msgid=161123&act=5ZJE&c=586627&admin=0&destination=http%3A%2F%2Fwww.themedicinescompany.com%2F>.
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 are able to obtain or maintain patent protection for the intellectual property relating to the Company’s products, 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 November 9, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Posted: November 2009