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CAMBRIDGE, MA — August 30, 2005 – Momenta
Pharmaceuticals, Inc. (Nasdaq: MNTA), announced today that an Abbreviated
New Drug Application (ANDA) seeking marketing approval of M-Enoxaparin
has been filed with the United States Food and Drug Administration (FDA).
Momenta is developing M-Enoxaparin, a technology-enabled generic version
of Lovenox®, in collaboration with Sandoz, the generics division
of Novartis AG.
Approved for the prevention and treatment of deep
vein thrombosis and treatment of acute coronary syndromes, Lovenox (enoxaparin
sodium injection) is a widely-prescribed low molecular weight heparin.
Sanofi-Aventis reported worldwide Lovenox sales of $2.4 billion in 2004.
“The ANDA for M-Enoxaparin is a major accomplishment
for Momenta, representing the first application for marketing approval
filed with the FDA based upon our technology,” said Alan Crane,
Chief Executive Officer of the Company. “We believe that our proprietary
approach to characterizing and sequencing complex sugars can be applied
to both the development of generic versions of complex drugs as well
as to the discovery and development of novel products based on sugars.”
Under the FDA’s ANDA requirements, a generic
drug must be shown to have, among other things, the same active ingredients
as the innovator product upon which the generic application is based.
Like other low molecular weight heparins, Lovenox consists of a heterogeneous
mixture of complex sugar chains. “We believe that our proprietary
technology enables us to analyze the Lovenox mixture and demonstrate
that M-Enoxaparin has the same active ingredients as Lovenox,”
said Mr. Crane.
About Momenta
Momenta Pharmaceuticals, Inc. is a biotechnology company specializing
in the sequencing, or detailed structural analysis, and design of complex
sugars for the development of novel drugs, the improvement of existing
drugs and the discovery of new biological processes. Momenta is also
utilizing its characterization technology to create technology-enabled
generic versions of complex and biologic drug products. Based on its
understanding of complex sugars, Momenta has created a diversified pipeline
of near-term product opportunities, novel development products and discovery
candidates. Momenta was founded in 2001 and is headquartered in Cambridge,
MA.
Forward Looking Statements
Statements in this press release regarding Momenta Pharmaceuticals Inc.’s
future expectations, beliefs, goals, intentions, strategies, plans or
prospects, including statements relating to the likelihood of approval
of its ANDA filing for M-Enoxaparin, future commercialization efforts
of M-Enoxaparin, corporate and development strategies and future development
programs, 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 June 30, 2005 filed with the Securities and
Exchange Commission under the section “Risk Factors That May Affect
Results,” 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, goals, intentions, strategies, plans or prospects 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 terms, variations
of such terms or the negative of such terms. Momenta assumes no obligations
to update the information included in this press release as a result
of new information, future events or otherwise.
Our logo, trademarks, and service marks are the property
of Momenta Pharmaceuticals, Inc. Lovenox® is a registered trademark
of Aventis Pharma S.A. All other trade names, trademarks, or service
marks are property of their respective owners.
Investor Contact:
Michael A. Lawless
Momenta Pharmaceuticals, Inc.
617-395-5189
Media Contact:
Kathryn Morris
Kathryn Morris PR
845-635-9828
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