HERTFORDSHIRE, England and
PITTSBURGH, March 13, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that Mylan has agreed to the
terms of a global settlement with Genentech, Inc. and F.
Hoffmann-La Roche Ltd. in relation to patents for Herceptin®
(trastuzumab), which provides Mylan with global licenses for its
trastuzumab product.
The global license will provide a clear pathway for Mylan to
commercialize its trastuzumab product in various markets around the
world, commencing on the license effective dates, which are
confidential. The licenses pertain to all countries except
Japan, Brazil and Mexico. In addition to eliminating any legal
uncertainty over the launch of Mylan's trastuzumab, the settlement
eliminates further patent litigation expenses associated with
Genentech and Roche.
Mylan has agreed to withdraw its pending Inter Partes Review
(IPR) challenges against two U.S. Genentech patents (patent numbers
6,407,213 and 6,331,415) as part of the settlement.
Following this settlement and the recent acceptance of Mylan's
application for its proposed biosimilar trastuzumab with the U.S.
Food and Drug Administration (FDA), Mylan anticipates potentially
being the first company to launch a biosimilar to Herceptin in the
U.S.
All other terms and conditions of the settlement and license
agreement are confidential.
Mylan CEO Heather Bresch
commented, "There is an unmet need for access to more affordable
versions of biologic products such as trastuzumab. We look forward
to enhancing access to this important treatment option, which
complements our comprehensive cancer care offerings, in the U.S.
and around the world. With 16 biosimilar products in development,
we believe Mylan has one of the industry's broadest portfolios of
biosimilars and that we will be a leader in bringing high-quality
biosimilar products to market given our ability not only to develop
and manufacture such complex products, but also to navigate the
intricate regulatory and legal environment and successfully
commercialize these products on a global basis."
Mylan's proposed biosimilar trastuzumab is one of the six
biologic products co-developed by Mylan and Biocon for the global
marketplace. Mylan has exclusive commercialization rights for the
proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New
Zealand and in the European Union and European Free Trade
Association countries. Biocon has co-exclusive commercialization
rights with Mylan for the product in the rest of the world.
In the U.S., Mylan's Biologics License Application (BLA) for
proposed biosimilar trastuzumab is currently under review by FDA.
The anticipated FDA goal date set under the Biosimilar User Fee Act
(BsUFA) is Sept. 3, 2017.
Mylan currently markets its trastuzumab products in 14 emerging
markets and has submissions pending in the European Union and
several additional emerging markets, in addition to the U.S.
This press release includes statements that constitute
"forward-looking statements," including with respect to whether the
global license will permit provide a clear pathway for Mylan to
commercialize its trastuzumab product in various markets around the
world; any legal uncertainty over the launch of Mylan's
trastuzumab; whether the settlement will eliminate further patent
litigation expenses associated with Genentech and Roche; Mylan's
ability to be the first company to launch a biosimilar to Herceptin
in the U.S.; Mylan's ability to enhance access to this important
treatment option for patients in the U.S. and around the world; and
Mylan's ability to be a leader in bringing high-quality biosimilar
products to market. 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: Mylan's ability to realize the anticipated
benefits of this legal settlement; any changes in or difficulties
with Mylan's or its partners' ability to develop, manufacture, and
commercialize its biosimilar products, including trastuzumab in
markets around the world; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring such
products to market; the impact of competition; changes in the
economic and financial conditions of the businesses of Mylan or its
partners; 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.
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 market a
growing portfolio of approximately 7,500 products around the world,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in more than 165 countries and territories.
We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
35,000-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.