CAMBRIDGE, Mass., Sept. 24, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the results from the EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) Phase 2 multicenter trial evaluating intravenous use of M118. The results were presented at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, being held in San Francisco, CA. Sunil V. Rao, M.D., co-principal investigator for the trial, presented the results as a "First Report" during a session on novel antithrombotic agents. Dr. Rao is an Assistant Professor of Medicine at the Duke University Medical Center and Director of the Cardiac Catheterization Laboratories at the Durham, NC Veterans Affairs Medical Center.

"M118, our first novel product engineered utilizing Momenta technology, was rationally designed to capture the positive attributes of both unfractionated heparin and low molecular weight heparin," commented Jim Roach, M.D., Chief Medical Officer at Momenta. "We are very pleased with the results from the EMINENCE trial, which support our belief that M118 has the potential to become the baseline anticoagulant of choice for treatment of patients diagnosed with acute coronary syndromes."

The primary objective of EMINENCE was 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 CAD 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 (MI), 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). Safety was also evaluated by assessing the incidence of adverse events and serious adverse events.

Key Results:

 * The combined incidence rate of the primary endpoint was 31.1% for
   patients in the UFH arm vs. 28.4% of patients in the combined
   M118 arms. A patient was included in the calculation of incidence
   of the primary endpoint if that patient experienced at least one
   of the events included in the composite endpoint.
 * The incidence rate of the primary endpoint excluding minor
   bleeding within 24 hours of PCI, a prespecified secondary
   endpoint, was 17.9% for patients in the UFH arm vs. 11.4% of
   patients in the 50 IU/kg M118 dosage arm, 12.5% of patients in
   the 75 IU/kg M118 dosage arm, and 14.1% of patients in the 100
   IU/kg M118 dosage arm.
 * The event rates for the prespecified composite secondary endpoint
   of death, MI, or repeat revascularization at 30 days -- a
   composite often used for pivotal registration trials -- were
   11.4%, 7.9%, and 6.4% in the 50 IU/kg, 75 IU/kg, and 100 IU/kg
   M118 dosage arms, respectively, vs. 8.6% of patients in the UFH
   arm. For death or MI at 30 days, the incidence was 11.4%, 6.6%,
   and 5.8% in the 50 IU/kg, 75 IU/kg, and 100 IU/kg M118 dosage
   arms, respectively, vs. 6.0% of patients in the UFH arm.
 * Bleeding, which was classified according to the REPLACE-2 scale,
   was comparable in all dose groups. Major bleeding occurred in
   1.3% of patients who received UFH vs. 2.3%, 0.7% and 1.3% in the
   50, 75 and 100-IU/kg M118 doses, respectively. Minor bleeds were
   reported in 15.9% of UFH patients and 11.4%, 17.1% and 19.9% for
   the 50, 75, and 100 IU/kg M118 doses, respectively.
      -- A post-hoc analysis evaluating the rate of bleeding by the
         TIMI scale showed comparable rates of either major
         (0.7% vs. 0.3%) or minor (1.4% vs.