- First generic multiple sclerosis product approved in
the United States
- Approval triggers $10 million milestone payment to
Momenta
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that
the U.S. Food and Drug Administration has granted marketing
approval of Sandoz's Abbreviated New Drug Application for once
daily Glatopa™ (glatiramer acetate injection, formerly M356) 20
mg/mL, a generic equivalent of daily COPAXONE® 20 mg. Glatopa is
the first substitutable generic indicated for the treatment of
patients with relapsing-forms of multiple sclerosis (RRMS), a
chronic disease of the central nervous system characterized by
inflammation and neurodegeneration. Glatopa was developed under a
collaboration agreement between Momenta and Sandoz and is the
second complex generic developed by Momenta together with Sandoz to
receive FDA approval. Glatopa will be commercialized under the
Sandoz brand.
"We are proud to be able to offer patients with multiple
sclerosis the first generic version of daily COPAXONE and the first
generic product in this space," said Craig Wheeler, President and
CEO, Momenta Pharmaceuticals. "The FDA approval of the ANDA for
once daily Glatopa further validates Momenta's approach of using
innovative physicochemical and biologic characterization to gain
approval of complex generics, biosimilars and novel drugs, and
advances Momenta's goal of expanding access to high quality, more
affordable medicines."
Glatopa was determined by the FDA to be therapeutically
equivalent to daily COPAXONE 20 mg, with the same active
ingredients, route of administration, strength and dosage form.
Glatopa's high quality U.S.-based supply chain and manufacturing
process meets rigid FDA standards, and Glatopa is fully
substitutable at the pharmacy level. Glatopa is expected to offer a
more affordable treatment option for people living with RRMS.
Under the terms of its collaboration agreement with Sandoz,
Momenta is eligible to receive up to $140 million in milestone
payments upon the achievement of certain U.S. regulatory,
commercial and sales-based milestones for Glatopa, including a
$10.0 million payment earned upon sole FDA approval of the ANDA,
and another $10.0 million milestone payment upon first commercial
sale.
Sandoz is currently evaluating launch timing.
Momenta will host a conference call and webcast for investors
today at 1:30 p.m. ET to discuss the approval of this important
generic medicine. Conference call and webcast details will follow
in a separate press release.
Conference Call Information
Momenta will host a conference call for investors on April 16,
2015 at 1:30 p.m. ET to provide more information about the Glatopa
approval. The conference call will be webcast live and a link to
the webcast may be accessed on the "Investors" section of the
company's website, www.momentapharma.com. Please go to the site at
least 15 minutes prior to the call to register, download, and
install any necessary software. An archived version of the webcast
will be posted on the Momenta website approximately two hours after
the call.
About Relapsing-Remitting Multiple Sclerosis
(RRMS)
Multiple sclerosis is a devastating chronic disease of the
central nervous system characterized by inflammation and
neurodegeneration. RRMS, defined by inflammatory attacks on the
protective coating of neurons (myelin) and characterized by
intermittent bouts of symptoms, is the most common disease course
at the time of diagnosis. COPAXONE is among the leading products
marketed for treatment of RRMS. It works by stopping the body from
damaging its own nerve cells (myelin). In North America, COPAXONE
is marketed by Teva Neuroscience, Inc., which is a subsidiary of
Teva Pharmaceuticals.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing
in the detailed structural analysis of complex 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 therapeutics for oncology and autoimmune
indications.
To receive additional information about Momenta, please visit
the website at www.momentapharma.com, which does not form a part of
this press release. The company's 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.
Forward Looking Statements
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, including statements relating to its beliefs and
intentions related to Glatopa, including those about distribution
and commercialization, pricing, potential sales or revenue, the
achievement of milestones and receipt of associated payments under
the Company's collaboration with Sandoz, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements may contain such
words 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. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors referred to in the Company's Annual
Report on Form 10-K for the year ended December 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 the date of this press release 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.
COPAXONE is a registered trademark of Teva Pharmaceuticals.
Glatopa is a trademark of Novartis AG.
CONTACT: Investor Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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