PARSIPPANY, NJ--(Marketwire - 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
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 =
"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
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.
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
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