The Medicines Company Announces FDA Approval of KENGREAL™ (cangrelor) as an Adjunct to Percutaneous Coronary Intervention (PCI) for Reducing Thrombotic Events

22 Jun 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).

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KENGREAL(TM)(cangrelor)(Photo: Business Wire)

KENGREAL(TM)(cangrelor)(Photo: Business Wire)

<p>
  The&nbsp;Medicines Company&nbsp;expects KENGREAL to be available in the U.S. in 
  July.
</p>
<p>
  KENGREAL is the first and only intravenous, reversible P2Y<sub>12</sub> 
  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.
</p>
<p>
  “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.”
</p>
<p>
  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 <i>The 
  New England Journal of Medicine</i>. 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.
</p>
<p>
  “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.”
</p>
<p>
  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.
</p>
<p>
  “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.”
</p>
<p>
  <b>Conference Call</b>
</p>
<p>
  The Company will discuss this approval during a call on&nbsp;June 23<sup>rd</sup> 
  at&nbsp;8:30 am ET. The conference call will be available via phone and 
  webcast. Dial-in information is listed below:
</p>
<p>
  Domestic Dial-in: +1 (877) 359-9508<br>International Dial-in: +1 (224) 
  357-2393<br>Passcode for both Dial-in numbers: 69887586
</p>
<p>
  Replay is available from&nbsp;11:30 am Eastern time&nbsp;following the conference 
  call through&nbsp;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.
</p>
<p>
  This call is being webcast and can be accessed via The Medicines Company 
  website at <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.themedicinescompany.com&amp;esheet=51128705&amp;newsitemid=20150622006274&amp;lan=en-US&amp;anchor=www.themedicinescompany.com&amp;index=1&amp;md5=b3502668181debf688e9638a9c34edf9" rel="nofollow">www.themedicinescompany.com</a>. 
  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 <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.themedicinescompany.com&amp;esheet=51128705&amp;newsitemid=20150622006274&amp;lan=en-US&amp;anchor=www.themedicinescompany.com&amp;index=2&amp;md5=04e0730c043571bc2711819f133bf91a" rel="nofollow">www.themedicinescompany.com</a>.
</p>
<p>
  <b>About KENGREAL™ (cangrelor)</b>
</p>
<p>
  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 P2Y<sub>12</sub> platelet inhibitor and are not 
  being given a glycoprotein IIb/IIIa inhibitor.
</p>
<p>
  <b>Important Safety Information</b>
</p>
<p>
  KENGREAL™ is contraindicated in patients with significant active 
  bleeding.
</p>
<p>
  KENGREAL™ is contraindicated in patients with known hypersensitivity 
  (e.g., anaphylaxis) to cangrelor or any component of the product.
</p>
<p>
  Drugs that inhibit platelet P2Y<sub>12</sub> 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.
</p>
<p>
  The most common adverse reaction is bleeding.
</p>
<p>
  Please see full prescribing information for KENGREAL, available at&nbsp;<a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.kengreal.com&amp;esheet=51128705&amp;newsitemid=20150622006274&amp;lan=en-US&amp;anchor=http%3A%2F%2Fwww.kengreal.com&amp;index=3&amp;md5=c5bc48fdbb9cdd056ce8803f27edf385" rel="nofollow">http://www.kengreal.com</a>.
</p>
<p>
  <b>About ANGIOMAX® (bivalirudin)</b>
</p>
<p>
  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.
</p>
<p>
  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.
</p>
<p>
  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.
</p>
<p>
  Please see full prescribing information for Angiomax, available at&nbsp;<a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.angiomax.com&amp;esheet=51128705&amp;newsitemid=20150622006274&amp;lan=en-US&amp;anchor=http%3A%2F%2Fwww.angiomax.com&amp;index=4&amp;md5=3b3232de8a3e1003b2919460e60b0a36" rel="nofollow">http://www.angiomax.com</a>.
</p>
<p>
  <b>About The&nbsp;Medicines Company</b>
</p>
<p>
  The&nbsp;Medicines Company's&nbsp;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&nbsp;Americas,&nbsp;Europe&nbsp;and the&nbsp;Middle East, and&nbsp;Asia 
  Pacific regions with global centers today in&nbsp;Parsippany, NJ, USA 
  and&nbsp;Zurich,&nbsp;Switzerland.
</p>
<p>
  <b>Forward-Looking Statements</b>
</p>
<p>
  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.
</p>
<p>
</p>


Contacts

The Medicines Company
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Neera.Ravindran@themedco.com

Contact Us

The Medicines Company
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Parsippany, NJ 07054 USA
Tel 973 290 6000
Toll-free 800 388 1183
Global Medical Information

Human Resources
Verification of employment
Tel 973 290 6361
Fax 862 207 6361

Investors Relations

Krishna Gorti, MD
Tel 973 290 6122
krishna.gorti@themedco.com

Media Inquiries

Michael Blash
Tel 973 290 6100
michael.blash@themedco.com