NEW ORLEANS, March 26, 2007 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the company's novel engineered heparin, M118, demonstrated superior efficacy to a standard dose of unfractionated heparin (UFH) in an animal model of acute arterial thrombosis. The electrolytic injury model mimics the physiological response that occurs following the rupture of an atherosclerotic plaque in a coronary artery, and indicates the potential for M118 to be used in patients diagnosed with acute coronary syndromes (ACS). The data was presented today at the American College of Cardiology's (ACC) 56th Annual Scientific Session.
M118 is a next-generation anticoagulant designed specifically for use in treating patients diagnosed with ACS. The intravenous formulation of M118 is currently being evaluated in a series of Phase I studies to evaluate its human safety, tolerability and pharmacokinetic profile. Momenta expects to announce results from its first Phase I study of the intravenous formulation of M118 in the second half of 2007 and initiate Phase II trials later this year.
"Our technology has resulted in a product that we believe combines the best attributes of existing heparin anticoagulants into one therapeutic agent," said Craig A. Wheeler, President and Chief Executive Officer of Momenta. "This preclinical study provides additional evidence that M118 could be a potent agent in the prevention of ischemic complications, representing a significant advancement in the treatment and management of ACS patients."
In the preclinical study, a dose of M118, matched on the basis of anticoagulant activity with a standard UFH dose used in clinical practice, demonstrated superior efficacy in preventing occlusion of an injured artery. This increase in efficacy did not result in an increased risk of bleeding. Previous preclinical studies have shown M118 to be at least as effective as unfractionated heparin in inhibiting clot formation without causing increased bleeding complications. Additionally, the study also demonstrated that the level of anticoagulation provided by M118 can be readily monitored using standard point-of-care coagulation assays.
A key unmet need in ACS is the lack of a flexible anticoagulant agent that can be used regardless of whether a patient requires coronary intervention or is treated medically with pharmacological agents. M118 has the potential to address this need as it combines the advantageous properties of unfractionated heparin, a preferred agent in ACS treatment due to its ability to be monitored and reversed, with the convenience and predictable pharmacokinetic properties of low molecular weight heparins.
About M118
M118 is a next-generation heparin drug candidate that has been, through Momenta's proprietary technology, rationally engineered 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 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, addressing the current unmet medical need within the ACS marketplace.
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, there are more than 1.9 million occurrences of either unstable angina or myocardial infarction requiring medical treatment across the U.S. 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 Pharmaceuticals
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. The Company's most advanced product candidate, M-Enoxaparin is designed to be a technology-enabled generic version of Lovenox(r). Momenta's first novel drug candidate is M118, a rationally engineered anticoagulant specifically designed for acute coronary syndromes. Within the Company's discovery program, it is seeking to discover and develop novel therapeutics by applying its technology to better understand sugars' functions in biological processes, with an initial focus in oncology. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in Cambridge, MA.
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 Momenta Pharmaceuticals, Inc.'s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's M118 program, including, the design, development, administration and application of such product candidate and the potential for the Company to demonstrate through preclinical and clinical studies that M118 is safe and effective, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Momenta's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in Momenta's Annual Report on Form 10-K for the year ended December 31, 2006 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. Forward-looking statements include statements regarding Momenta's expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. Momenta assumes no obligations to update the information included in this press release.
Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.