HERTFORDSHIRE, England and
PITTSBURGH, Jan. 8, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced that it has entered into an exclusive
global collaboration agreement with Momenta Pharmaceuticals, Inc.
(Nasdaq: MNTA) to develop, manufacture and commercialize six of
Momenta's current biosimilar candidates, including Momenta's
biosimilar candidate, ORENCIA® (abatacept).
Mylan CEO Heather Bresch
commented, "Mylan's long-stated strategy has been to strategically
invest in the long-term drivers of our future growth, both through
our strong internal focus on R&D and through external
collaboration with industry-leading partners. Biosimilars have long
been one of these areas of important future growth, both for our
company and our industry, given the rapidly growing market for
biologic products, the undeniable patient need for more affordable
versions of these life-saving medicines, and the attractive
competitive landscape for the companies that are able to
successfully bring these complex products at scale to the global
market. This collaboration with Momenta, which is highly
complementary to our partnership with Biocon, will position us as a
definitive world leader in biosimilars, with a broad portfolio of
15 biosimilar/insulin analog generic products in development and
the scale required to maximize investment in this area. Looking
forward, Mylan will continue to expand and diversify its portfolio
into such complex products, further differentiating us from other
leading generics companies and establishing us at the forefront of
the biologics space, while also ensuring we maintain one of the
broadest, highest quality portfolios in our industry."
"This exciting collaboration with Momenta is focused on the next
wave of biosimilar products and represents an important next step
for Mylan, leveraging Momenta's unique technology capabilities and
Mylan's strong science, biosimilar-development experience,
operational excellence and expansive global commercial footprint.
Importantly, this collaboration builds upon Mylan's existing
successful biologics and insulins collaboration with Biocon, which
is focused on more near-term biosimilar opportunities. Through
these partnerships, as well as 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," continued Ms. Bresch.
Craig A. Wheeler, president and
chief executive officer of Momenta Pharmaceuticals, said, "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. 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."
Under the agreement with Momenta, Mylan will make an up-front
cash payment of $45 million and up to
$200 million in contingent
milestone-related 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. All other
financial terms and product details remain confidential.
Mylan's collaboration with Momenta builds upon Mylan's existing
biologics and insulin analog partnership with Biocon. The Biocon
partnership includes six biosimilar programs (trastuzumab,
pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim)
and three insulin analogs (glargine, lispro and aspart). Five of
these biosimilar programs have successfully completed Phase I
clinical trials, and four of the programs are in active Phase III
testing. Mylan and Biocon plan on submitting three biosimilar
applications and one insulin application in the U.S. and
Europe in 2016. Mylan already has
successfully launched its trastuzumab biosimilar product in
India and other emerging
markets.
Mylan President Rajiv Malik
commented, "Mylan has been fully engaged in the development of
biosimilars with our partner Biocon for the last six years. During
that time, Mylan has cultivated strong experience and expertise in
the development of biosimilar products, and is executing on our
programs with the scientific and analytical rigor required to
fulfill health-authority expectations. Based upon our proactive and
informative interactions with global health authorities on our nine
active programs, we are extremely optimistic about the strength of
our current development programs with Biocon, and we look forward
to deploying our expertise in our collaboration with Momenta."
Momenta also is providing information regarding the
collaboration on its website.
Forward Looking Statement for Mylan
This press release includes statements that constitute
"forward-looking statements," including with regard to statements
that biosimilars has long been an area of important future growth,
both for Mylan and its industry, given the rapidly growing market
for biologic products, the undeniable patient need for more
affordable versions of these medicines, and the attractive
competitive landscape for the companies that are able to
successfully bring these complex products at scale to the global
market; that the collaboration with Momenta, which is highly
complementary to Mylan's partnership with Biocon, will position
Mylan as a definitive world leader in biosimilars with a broad
portfolio of 15 biosimilar/insulin analog generic products in
development and the scale required to maximize investment in this
area; that Mylan will continue to expand and diversify its
portfolio into such complex products, further differentiating it
from other leading generics companies and establishing us at the
forefront of the biologics space, while also ensuring it maintains
one of the broadest, highest quality portfolios in its industry;
that the collaboration with Momenta is focused on the next wave of
biosimilar products and represents an important next step for
Mylan, leveraging Momenta's unique technology capabilities and
Mylan's strong science, biosimilar development experience,
operational excellence and expansive global commercial footprint;
that through Mylan's partnerships, as well as the strong internal
capabilities it has 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; that Mylan
and Momenta have a common focus on building an industry leading
biosimilar portfolio that offers safe, effective and affordable
products to the patients that need them; that Mylan and Momenta's
joint vision is to bring high quality, cost effective biosimilar
products to markets worldwide and they believe their success will
deliver a strong return to their respective stakeholders; that
Mylan and Biocon plan on submitting three biosimilar applications
and one insulin application in the U.S. and Europe in 2016; that Mylan is executing on its
programs with the scientific and analytical rigor required to
fulfill health authority expectations; and that Mylan is extremely
optimistic about the strength of its current development programs
with Biocon and looks forward to deploying its expertise in our
collaboration with Momenta. 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.
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 about our and Mylan's ability to
successfully develop and commercialize high quality, cost-effective
biosimilar products; compete successfully in biosimilars; and
increase shareholder value. 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 Momenta'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 Momenta 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 above by Mylan,
Momenta'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
information in this press release as of this date and assumes no
obligations to update the information or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
About Mylan
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 1,400 generic and branded pharmaceuticals,
including antiretroviral therapies on which nearly 50% of people
being treated for HIV/AIDS in the developing world depend. We
market our products in approximately 165 countries and territories.
Our global R&D and manufacturing platform includes more than 50
facilities, and we are one of the world's largest producers of
active pharmaceutical ingredients. Every member of our more than
30,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
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SOURCE Mylan N.V.