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MNTA Reports Results from M118 Drug-Interaction Study with Aspirin and Plavix

[No drug interaction was encountered and there were no SAE’s in this phase-1 study. Inasmuch as aspirin and Plavix are part of the SoC in ACS, the lack of a drug interaction with M118 is consequential, although expected.]

http://biz.yahoo.com/pz/080728/147278.html

›Monday July 28, 1:30 pm ET

Results Presented at IXth World Conference on Clinical Pharmacology and Therapeutics Meeting

CAMBRIDGE, Mass., July 28, 2008 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM: MNTA ), a biotechnology company specializing in the characterization and engineering of complex drugs, today presented results from a Phase 1 study of M118, its rationally engineered anticoagulant, demonstrating the absence of a significant drug-drug interaction between M118 and aspirin (ASA) and clopidogrel. This data is being presented at the IXth World Conference on Clinical Pharmacology and Therapeutics Meeting in a poster titled ``Lack of Drug-Drug Interactions with M118, a Novel, Rationally Engineered Low Molecular Weight Heparin, When Co-Administered with Multiple Doses of Aspirin and Clopidogrel.'

``The absence of a significant drug-drug interaction between M118 and aspirin and clopidogrel, which are standard of care to treat patients diagnosed with acute coronary syndromes (ACS), is an important finding for our program and advances our understanding of how M118 could potentially be incorporated into treatment paradigms in the settings of acute coronary syndromes and percutaneous coronary intervention,' said Jim Roach, MD, Chief Medical Officer of Momenta.

The Phase I trial was designed to evaluate the safety and tolerability of M118 in combination with ASA and clopidogrel, the impact of multiple doses of ASA and clopidogrel on the pharmacokinetics (PK) and pharmacodynamics (PD) of an IV injection of M118 and the impact of a single IV injection of M118 on the PK and PD of ASA and clopidogrel.

This randomized, double-blind, placebo-controlled, crossover study was conducted in 15 healthy subjects receiving IV M118 (75 IU/kg) alone, ASA (325mg) and clopidogrel (300mg loading-dose + 75mg) administered together, and the combination of all three drugs. Each subject received all three treatments. Blood samples were collected for the determination of anti-Factor Xa and anti-Factor IIa activities, ASA, Salicylic Acid (SA) and clopidogrel levels. PD and safety monitoring included Activated Clotting Time (ACT), bleeding time (BT) and platelet aggregation (PA).

These results indicate that there was no significant drug interaction between the agents. With respect to PD effects, the administration of M118 had no effect on the inhibition of platelet aggregation or the increase in bleeding time caused by the combination of ASA plus clopidogrel. In addition, M118 administration increased ACT and the administration of the combination of ASA plus clopidogrel had no effect on this increase. No severe or serious adverse events occurred in the study.

About M118

M118 is a novel drug candidate that has been rationally engineered using Momenta's proprietary technology and analytical methods to provide anticoagulant therapy to patients with ACS. M118 is designed to interact at multiple points in the coagulation cascade by selectively binding to anti-thrombin III and thrombin, two critical factors in the formation of clots. In preclinical and Phase 1 studies, data have shown that M118 is a potent inhibitor of multiple factors in the blood that lead to clot formation, its effects can be reversed or neutralized and its activity can be monitored. An anticoagulant possessing these properties has the potential to satisfy a currently unmet medical need within the ACS patient population.

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 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. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in Cambridge, MA.‹


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