Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced
that it has entered into an exclusive global collaboration
agreement with Mylan N.V. (Nasdaq:MYL), (TASE:MYL) to develop,
manufacture and commercialize six of Momenta’s current biosimilar
candidates, including Momenta’s biosimilar candidate ORENCIA®
(abatacept).
“We are thrilled to welcome Mylan as our new
collaboration partner for biosimilars. Our two companies have a
common focus on building an industry leading biosimilar portfolio
that offers safe, effective and affordable products to the patients
that need them,” said Craig A. Wheeler, President and Chief
Executive Officer of Momenta Pharmaceuticals. “By combining
Momenta’s proven capabilities in complex product development and
Mylan’s world class global R&D, supply chain and commercial
infrastructure, we are well positioned to become a strong
competitor in this developing field. Our joint vision is to bring
high quality, cost effective biosimilar products to markets
worldwide and we believe our success will deliver a strong return
to our companies’ stakeholders.”
Mylan CEO Heather Bresch commented, “This
exciting collaboration with Momenta is focused on the next wave of
biosimilar products and represents an important next step for Mylan
in this area of significant future growth, leveraging Momenta’s
unique technology capabilities and Mylan’s strong science,
biosimilar development experience, operational excellence and
expansive global commercial footprint. Through this collaboration,
as well as other partnerships and the strong internal capabilities
we have cultivated, Mylan is further expanding what is already one
of the industry’s most robust and diverse biosimilar portfolios and
helping to ensure we can deliver enhanced access to these critical
products to patients around the world.”
Under the agreement, Mylan will make an upfront
cash payment of $45 million and up to $200 million in contingent
milestone payments to Momenta, with each company sharing equally in
the costs and profits with respect to the products. The companies
will be jointly responsible for product development and Mylan will
lead worldwide commercialization efforts, with Momenta having an
option to co-commercialize in a supporting commercial role, any
approved products in the United States.
Conference Call Information
Momenta will host a conference call for
investors today at 10 am ET to discuss this important biosimilars
collaboration with Mylan. 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.
To access the call you may also dial (877)
224-9084 (domestic) or (720) 545-0022 (international) prior to the
scheduled conference call time and provide the access code
21610391. A replay of the call will be available approximately two
hours after the conclusion of the call. To access the replay,
please dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and provide the access code 21610391.
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.
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.
Forward Looking Statement For Momenta
Pharmaceuticals
Statements in this press release regarding
management's future expectations, beliefs, intentions, goals,
strategies, plans or prospects, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including but not limited to, statements concerning the
collaboration agreement between Mylan N.V. and Momenta
Pharmaceuticals, Inc., including anticipated payments, as well as
future development, manufacture, and commercialization of
biosimilars under the agreement; and our and Mylan’s ability to
successfully develop and commercialize high quality, cost-effective
biosimilar products, compete successfully in biosimilars, and
increase shareholder value. Forward-looking statements
may be identified by words such as "anticipate," "believe,"
“continue,” "could," "hope," "target," "project," "goal,"
“objective,” “guidance,” “plan,” "potential," "predict," "might,"
"estimate," "expect," "intend," "may," “seek”, "should," "will,"
"would," "look forward" and other similar words or expressions, or
the negative of these words or similar words or
expressions. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors, including receiving
clearance under the Hart-Scott-Rodino Antitrust Improvements Act
and those referred to under the section “Risk Factors” in the
Company's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2015 filed with the Securities
and Exchange Commission, as well as other documents that may be
filed by the Company from time to time with the Securities and
Exchange Commission. As a result of such risks, uncertainties
and factors, or the risks and factors noted below by Mylan N.V.,
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. The
Company 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.
Forward Looking Statement for Mylan N.V.
This press release includes statements that constitute
“forward-looking statements,” including with regard to statements
that the collaboration is focused on the next wave of biosimilar
products and represents an important next step for Mylan in this
area of significant future growth, leveraging Momenta’s unique
technology capabilities and Mylan’s strong science, biosimilar
development experience, operational excellence and expansive global
commercial footprint and that Mylan is further expanding what is
already one of the industry’s most robust and diverse biosimilar
portfolios and helping to ensure it can deliver enhanced access to
these critical products to patients around the world. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Because such
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to: any changes in or difficulties with Mylan’s or its
partners’ ability to develop, manufacture, and commercialize
biosimilar candidates; any regulatory, legal, or other impediments
to Mylan’s or its partners’ ability to bring biosimilar candidates
to market; Mylan’s and its partners’ ability to protect
intellectual property and preserve intellectual property rights,
including with respect to biosimilar candidates; the effect of any
changes in Mylan’s or its partners’ customer and supplier
relationships and customer purchasing patterns; other changes in
third-party relationships; the impact of competition; changes in
the economic and financial conditions of the businesses of Mylan or
its partners; the scope, timing, and outcome of any ongoing legal
proceedings and the impact of any such proceedings on Mylan’s or
its partners’ business; actions and decisions of healthcare and
pharmaceutical regulators, and changes in healthcare and
pharmaceutical laws and regulations, in the United States and
abroad; risks associated with international operations; clearance
under the Hart-Scott-Rodino Antitrust Improvements Act; other
uncertainties and matters beyond the control of management; and the
other risks detailed in Mylan's filings with the Securities and
Exchange Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
MOMENTA INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MOMENTA MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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