FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor

FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor 
PARSIPPANY, NJ -- (Marketwired) -- 02/12/14 --  The Medicines Company
(NASDAQ: MDCO) announced today that the U.S. Food and Drug
Administration (FDA) Cardiovascular and Renal Drugs Advisory
Committee (CRDAC) has voted to recommend against approval of the
intravenous antiplatelet agent cangrelor for use in patients
undergoing percutaneous coronary intervention (PCI) -- or cardiac
stent procedures -- or those that require bridging from oral
antiplatelet therapy to surgery.  
The committee recommendation is not binding on the FDA, which makes
the final decision on approval. The Prescription Drug User Fee Act
(PDUFA) goal date for the cangrelor new drug application (NDA) is
April 30, 2014.  
"Although we are disappointed by the Committee's decision, we
appreciate the dialogue during today's meeting and look forward to
subsequent discussion with the FDA," said Clive A. Meanwell, MD, PhD,
the company's Chairman and Chief Executive Officer. "We continue to
believe in the safety and efficacy of cangrelor and look forward to
working with the Agency as it completes its review." 
The cangrelor NDA and presentations before the Committee focused on
four randomized, double-blind clinical trials (CHAMPION PHOENIX,
CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE) conducted in more than
25,000 patients with coronary artery disease. 
About cangrelor 
Cangrelor is an investigational agent not approved for commercial use
in any market. Cangrelor, an immediately bioavailable and quickly
reversible intravenous small molecule antiplatelet agent, is in
development to prevent platelet activation and aggregation that leads
to thrombosis in the acute care setting including in patients
undergoing PCI. 
The results of CHAMPION PHOENIX, an 11,145 patient Phase 3
randomized, double-blind clinical trial comparing The Medicines
Company's intravenous antiplatelet cangrelor to oral clopidogrel in
patients undergoing PCI were reported in March 2013. 
In 2011, The Medicines Company also reported results of the BRIDGE
trial, a prospective, randomized, double-blind, placebo-controlled
multicenter trial which evaluated cangrelor or placebo in 210
patients with an acute coronary syndrome (ACS) or treated with a
coronary ste
nt that were at increased risk of thrombotic events
following discontinuation of oral platelet inhibition prior to
coronary artery bypass graft (CABG) surgery. 
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: acute cardiovascular care, surgery and perioperative
care, and serious infectious disease 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. 
Forward-Looking Statements
 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,"
"plans, "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 the Company's regulatory submissions will receive
approvals from regulatory agencies on a timely basis or at all,
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 5, 2013, which are incorporated herein by
reference. The Company specifically disclaims any obligation to
update these forward-looking statements. 
CONTACT:
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
The Medicines Company
+1 (973) 290-6044
neera.ravindran@themedco.com 
 
 
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