Momenta Pharmaceuticals Announces Top-Line Results From the M118 EMINENCE Trial
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CAMBRIDGE, Mass., June 29, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals,
Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization
and engineering of complex drugs, today announced top-line results from the
EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) phase 2
multicenter study of the intravenous formulation of M118.
EMINENCE was designed to evaluate the safety and feasibility of utilizing M118
as an anticoagulant in the target population of patients with stable coronary
artery disease (CAD) undergoing a percutaneous coronary intervention (PCI).
Approximately 500 patients with stable coronary artery disease undergoing
elective PCI were randomly assigned to receive treatment with one of three doses
of intravenous M118 or a standard dose of unfractionated heparin (UFH).
The primary endpoint of the study was the combined incidence of clinical events
defined as the composite of death, myocardial infarction, repeat
revascularization, and stroke (over thirty days); incidence of bleeding and
thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein
IIb/IIIa inhibitors and catheter thrombus (during the procedure). The primary
analysis in the study provided evidence of non-inferiority of the combined M118
group (combining all three doses) as compared to the UFH group within the
parameters of the prospectively defined analysis. The observed incidence of the
composite endpoint was lower in all M118 treatment groups than in the UFH group;
however it should be noted that the study was not designed or powered to detect
statistically significant differences between treatments. The incidence of
serious and non-serious adverse events was comparable in all treatment groups.
The EMINENCE trial was conducted in collaboration with the Duke Clinical
Research Institute (DCRI). "Considering the relatively high incidence of event
rates that we continue to observe in ACS clinical trials, it is important to
continue to carefully evaluate investigational compounds in the search for
better alternatives," stated Dr. Robert Harrington, Director of the DCRI. "While
it is encouraging that the EMINENCE trial met its primary endpoint in this phase
2 study, it will be critically important - as is the case with any promising
compound in development - to carefully study both efficacy and safety in larger
clinical trials to better characterize its clinical potential."
"With the successful completion of EMINENCE, the first M118 trial conducted in
patients with coronary artery disease, we have achieved an important milestone
in the M118 development program. We believe these results are supportive of the
proof of principle that a novel, rationally designed low molecular weight
heparin could potentially address some of the limitations of currently available
therapy in patients with ACS, and hope to present the comprehensive trial
results at an appropriate scientific forum later in the year," commented Jim
Roach, M.D., Chief Medical Officer at Momenta.
About M118
M118 is a novel anticoagulant that has been rationally engineered using
Momenta's proprietary technology and analytical methods to provide anticoagulant
therapy to patients with acute coronary syndrome (ACS). M118 is designed to
interact at multiple points in the coagulation cascade by selectively binding to
both anti-thrombin III and thrombin, two critical factors involved in the
formation of clots. Preclinical and phase 1 studies have shown that M118 is a
potent inhibitor of multiple factors in the blood that lead to clot formation,
that its anticoagulant effects can be neutralized and that its activity can be
monitored with standard point-of-care assays. An anticoagulant possessing these
properties has the potential to satisfy a currently unmet medical need within
the ACS patient population by capturing, in a single anticoagulant therapy, the
positive attributes of both UFH (reversibility, monitorability and broad
inhibition of the coagulation cascade) and low molecular weight heparins
(adequate bioavailability and predictable pharmacokinetics to allow for
convenient subcutaneous administration). M118 is designed to be an anticoagulant
that could potentially be used in multiple settings, including initial medical
management of ACS, angioplasty or coronary artery bypass surgery.
About Acute Coronary Syndromes
ACS is characteristically used to describe patients experiencing an acute
myocardial infarction, or heart attack, as well as patients who present at
hospitals with unstable angina, a transient blockage of a coronary artery.
According to the National Hospital Discharge Survey, each year in the United
States there are more than 1.5 million occurrences of either unstable angina or
myocardial infarction requiring medical treatment. As part of the treatment of
ACS, anticoagulant agents are routinely administered to prevent the accumulation
and formation of blood clots which can lead to serious, life-threatening
complications.
About Momenta
Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge,
MA, specializing in the detailed structural analysis of complex mixture drugs.
Momenta is applying its technology to the development of generic versions of
complex drug products, as well as to the discovery and development of novel
drugs.
To receive additional information about Momenta, please visit the website at
www.momentapharma.com, which does not form a part of this press release.
Forward Looking Statements
Statements in this press release regarding management's future expectations,
beliefs, intentions, goals, strategies, plans or prospects relating to the
future clinical development and utility of M118 may constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. In particular, statements in this press release regarding the preliminary,
top-line assessment of the study data and its implications for future clinical
trials, the future development of M118, and the timing of any future trials are
forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or implied
by such statements. These statements are subject to the risk that further
analyses of the study data may lead to different (including less favorable)
interpretations of the data than the preliminary analyses conducted to date
and/or may identify important implications of the study data that are not
reflected in these statements. Clinical trial data are subject to differing
interpretations, and regulatory agencies, medical and scientific experts and
others may not share the Company's views of the study data, or its implications
for the remaining clinical trials, and the future development and
commercialization of M118. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors referred to in the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 filed with
the Securities and Exchange Commission under the section "Risk Factors," as well
as other documents that may be filed by Momenta from time to time with the
Securities and Exchange Commission. As a result of such risks, uncertainties and
factors, the Company's actual results may differ materially from any future
results, performance or achievements discussed in or implied by the
forward-looking statements contained herein. Momenta is providing the
information in this press release as of this date and assumes no obligation to
update the information included in this press release or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
Our logo, trade names and service marks are the property of Momenta
Pharmaceuticals, Inc. Other trademarks or service marks appearing in this press
release are the property of their respective owners and are not the property of
Momenta Pharmaceuticals, Inc. or its subsidiaries.
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CONTACT: Momenta Pharmaceuticals, Inc.
Beverly Holley
617-395-5189
bholley@momentapharma.com
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