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Novel Compound Designed Using Momenta’s Proprietary
Technology
CAMBRIDGE, MA — July 31, 2006
— Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology
company specializing in the characterization and engineering of complex
drugs, announced today that it has submitted an electronic Investigational
New Drug (IND) application to the U.S. Food and Drug Administration
to begin a Phase I human clinical study of M118, the Company’s
lead novel development candidate. M118 is an anticoagulant designed
specifically to treat acute coronary syndromes (ACS).
Momenta developed M118 using its proprietary technology for the detailed
analysis and design of complex sugar therapeutics. By isolating, characterizing
and engineering the key sugar structures within heparin that contribute
to anticoagulation, Momenta designed a proprietary compound that it
believes could provide baseline anticoagulant therapy to treat ACS patients
who require a coronary intervention, as well as those ACS patients who
are medically managed, or do not require intervention in order to treat
their coronary attack. M118 is designed to be a reversible and monitorable
anticoagulant that has a pharmacokinetic profile similar to a low molecular
weight heparin. Thus, M118 is designed to be a therapeutic option that
can be used across a variety of ACS treatment paths.
“M118 has the potential to be a significant future advancement
in the treatment and management of ACS,” said Alan Crane, CEO
of Momenta. “We are very encouraged by our preclinical studies
which show that M118 could be a potent agent that provides consistent,
flexible and reversible anticoagulant therapy. We look forward to continuing
to advance M118 into Phase I clinical trials in the coming months.”
“M118 illustrates the potential of our technology,
particularly our ability to leverage analytics and engineering to create
novel drug candidates,” continued Mr. Crane. “The filing
of the M118 IND also demonstrates our technology’s capability
to generate a large number of product opportunities as we add and advance
both complex generic and novel products to our growing pipeline.”
Background on M118
M118 directly leverages Momenta’s technology
for characterizing complex mixtures, correlating specific chemical structures
to biological activity, and applying these structure-function relationships
to design therapies with improved clinical properties. This “rational”
engineering process has resulted in a product design that we believe
combines in one molecule, the best attributes of existing anticoagulants.
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. We believe M118
can directly overcome this challenge as it combines the advantageous
properties of unfractionated heparin, a preferred agent in ACS because
of its ability to be reversed and monitored, with the convenience and
predictable pharmacokinetic properties of low molecular weight heparins.
Based on preclinical studies, M118 has been shown to be at least as
effective in inhibiting clot formation as unfractionated heparin without
causing increased bleeding complications. Moreover, preclinical studies
found that M118’s anticoagulant activity was reversible by protamine
sulfate, unlike currently marketed low molecular weight heparins or
direct thrombin inhibitors. Finally, the preclinical studies also demonstrated
that the level of anticoagulation provided by M118 can be readily monitored
using standard point-of-care coagulation assays.
Background on 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
Momenta Pharmaceuticals is a biotechnology company specializing in the
detailed characterization and engineering of complex sugars. Momenta
is applying its technology to create technology-enabled generic versions
of sugar-based and other complex drug products, develop improved versions
of existing drugs, and discover novel drugs and new biological processes.
The Company’s most advanced product candidate is M-Enoxaparin,
a technology-enabled generic version of Lovenox®. In accordance
with its collaboration with Sandoz, the generics business of Novartis
AG, an ANDA was submitted to the FDA for M-Enoxaparin in August 2005.
Momenta has multiple technology-enabled generic products in its pipeline.
Momenta’s first novel drug candidate is M118. The Company is developing
other novel drug candidates through its discovery effort focused on
understanding sugar-based biological processes. 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 Quarterly Report on Form 10-Q for the quarter ended
March 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.
Momenta Contacts:
Michael Lawless
Investor Relations
617-395-5189
Media Inquiries:
Barbara Yates
Yates and Associates
781-258-6153
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