The Medicines Company Announces FDA Approval of KENGREAL (cangrelor) as an Adjunct to Percutaneous Coronary Intervention (PCI) for Reducing Thrombotic Events
Novel intravenous antiplatelet agent adds to MDCO commercial offerings in the cardiac cath lab
Field force in place and product ready for supply in July
PARSIPPANY, N.J.--(BUSINESS WIRE)--Jun. 22, 2015-- The Medicines Company (NASDAQ:MDCO) today announced the approval of KENGREAL™ (cangrelor) by the U.S. Food and Drug Administration (FDA) as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor (GPI).
The Medicines Company expects KENGREAL to be available in the U.S. in July.
KENGREAL is the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI that, in clinical trials, has been shown to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization.
"The approval of KENGREAL provides a new option for PCI," said Clive A. Meanwell, MD, PhD, Chairman and Chief Executive Officer, The Medicines Company. "This novel drug will potentially decrease thrombotic risk in the acute care setting, deliver value to the healthcare system alongside Angiomax®, and help us to increase our commercial offerings in the cath lab."
The CHAMPION PHOENIX study provided the primary evidence of efficacy for the approval of KENGREAL™. The results of this trial, an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing KENGREAL to oral clopidogrel in patients undergoing PCI, were published in The New England Journal of Medicine. Co-principal investigators for the CHAMPION clinical program were Robert A. Harrington, MD, Professor and Chair of the Department of Medicine, Stanford University Medical School, Stanford, CA and Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital, Boston, MA and Professor, Harvard Medical School, Boston, MA.
"In the U.S., the vast majority of PCI procedures are done on an ad hoc basis because clinicians want to define the coronary anatomy prior to making a treatment decision," said J. Jeffrey Marshall, MD, FACC, FSCAI, Director, Cardiac Catheterization Lab, Northeast Georgia Medical Center and Past President, Society for Cardiovascular Angiography and Interventions (SCAI). "Cangrelor provides a benefit because it allows for antiplatelet therapy to be initiated just after the decision for PCI has been made."
PCI, commonly known as coronary angioplasty, is a non-surgical procedure used to treat narrowed arteries found in coronary heart disease. More than 700,000 PCI procedures each year in the U.S. require effective antithrombin and antiplatelet therapy. KENGREAL has the potential to address the unmet needs of these patients and is well-suited for contemporary U.S. practice in the cath lab.
"I believe that intravenous cangrelor has the potential to substantially improve outcomes for patients with cardiovascular disease because of its immediate onset of near complete platelet inhibition with rapid reversibility," said Gregg Stone, MD, Director of Cardiovascular Research and Education, Columbia University Medical Center, New York-Presbyterian Hospital. "With decreasing door-to-procedure times and the limitations of all oral anti platelet agents, I believe cangrelor will be widely embraced by the interventional community."
The Company will discuss this approval during a call on June 23rd at 8:30 am ET. The conference call will be available via phone and webcast. Dial-in information is listed below:
Domestic Dial-in: +1 (877) 359-9508
International Dial-in: +1 (224) 357-2393
Passcode for both Dial-in numbers: 69887586
Replay is available from 11:30 am Eastern time following the conference call through July 1, 2015. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial-in numbers is 69887586.
This call is being webcast and can be accessed via The Medicines Company website at www.themedicinescompany.com. In addition, the slides that will be used during the call can found on the event page of the Investor Relations section of our website at www.themedicinescompany.com.
About KENGREAL™ (cangrelor)
KENGREAL, a synthetic, small molecule, is 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 cangrelor 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.
Please see full prescribing information for KENGREAL, available at http://www.kengreal.com.
About ANGIOMAX® (bivalirudin)
Angiomax® is indicated in patients undergoing 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 unstable angina 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.
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. 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.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
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," "expects," "hopes" and "potential" 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 physicians, patients and other key decision makers will accept clinical trial results, the Company's ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, whether third parties on whom the Company relies to manufacture and support the development and commercialization of KENGREAL are able to fulfill their obligations or the Company is able to establish or maintain such arrangements; 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 with the SEC on March 5, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150622006274/en/
Source: The Medicines Company
The Medicines Company
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Communications
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning