Momenta Pharmaceuticals Receives Orphan Drug Designation for Necuparanib (Formerly M402) in Pancreatic Cancer
June 05 2014 - 8:01AM
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that
its novel oncology candidate, necuparanib (formerly M402), has
received Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for the treatment of pancreatic cancer.
"We are pleased to receive Orphan Drug Designation for
necuparanib, which highlights the great need for new medications
for patients suffering from pancreatic cancer," said Jim Roach MD,
Chief Medical Officer of Momenta Pharmaceuticals. "We are
encouraged by the progress of the program to date, and in the next
several months, we anticipate completing Part A of our ongoing
Phase 1/2 study of necuparanib in combination with Abraxane® and
gemcitabine. We look forward to sharing the results from Part A and
advancing the product into the Phase 2 part of the study in the
second half of 2014."
The FDA's Orphan Drug Designation program provides orphan status
to drugs and biologics intended to treat, diagnose or prevent rare
diseases/disorders, defined as affecting fewer than 200,000 people
in the U.S. This designation provides certain incentives, including
federal grants, tax credits, waiver of PDUFA filing fees and a
seven-year marketing exclusivity period against competition once
the product is approved.
About Necuparanib
The United States Adopted Names (USAN) Council has recently
adopted "necuparanib" as the unique non-proprietary name for M402.
Necuparanib, a heparan sulfate mimetic, is a novel oncology drug
candidate engineered to have a broad range of effects on tumor
cells. The use of heparins to treat venous thrombosis in cancer
patients has generated numerous reports of antitumor activity;
however, the dose of these products has been limited by their
anticoagulant activity. Necuparanib, which is derived from
unfractionated heparin, has been engineered to have significantly
reduced anticoagulant activity while preserving the relevant
antitumor properties of heparin. In the next several months,
Momenta expects to complete the Part A dose escalation component of
the Phase 1/2 trial evaluating necuparanib in combination with
Abraxane® (nab-paclitaxel) and gemcitabine in patients with
advanced metastatic pancreatic cancer, and to report clinical data
from Part A in the second half of 2014. The company plans to
initiate Part B of the study by the end of 2014. Part B will be a
randomized, controlled, proof of concept study to evaluate the
antitumor activity of necuparanib in combination with Abraxane plus
gemcitabine, versus Abraxane plus gemcitabine alone.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing
in the detailed structural analysis of complex mixture drugs and is
headquartered in Cambridge, MA. Momenta is applying its technology
to the development of generic versions of complex drugs, biosimilar
and potentially interchangeable biologics, and to the discovery and
development of novel products.
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 management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, the Company's revenue, expenses, including the results
and timing for necuparanib clinical trial results, constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by terminology such as "anticipate,"
"believe," "could," "could increase the likelihood," "hope,"
"target," "project," "goals," "potential," "predict," "might,"
"estimate," "expect," "intend," "is planned," "may," "should,"
"will," "will enable," "would be expected," "look forward," "may
provide," "would" or similar terms, variations of such terms or the
negative of those terms. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors referred
to in the company's Quarterly Report on Form 10-Q for the quarter
ended March 31, 2014 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. As a result of such risks,
uncertainties and factors, the Company's actual results may differ
materially from any future results, performance or achievements
discussed in or implied by the forward-looking statements contained
herein. Momenta is providing the information in this press release
as of this date and assumes no obligations to update the
information included in this press release or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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.
CONTACT: IR CONTACT:
Momenta Pharmaceuticals, Inc.
IR@momentapharma.com
MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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