HERTFORDSHIRE, England and
PITTSBURGH, Dec. 13, 2018 /PRNewswire/ -- Mylan N.V.
(NASDAQ: MYL) today announced that the U.S. Patent and
Trademark Appeal Board (PTAB) has ruled in favor of Mylan in its
inter partes review (IPR) proceedings and found all claims
of Sanofi's Lantus (insulin glargine 100 Units/mL) formulation
patents (U.S. Patent Nos. 7,476,652 and 7,713,930) unpatentable.
Lantus is a long-acting insulin used to treat adults with type 2
diabetes and adults and pediatric patients with type 1 diabetes for
the control of high blood sugar. Sanofi sells the product in vials
(Lantus) and as a disposable injection pen (Lantus
SoloSTAR®). Mylan's 505(b)(2) New Drug Application (NDA) for
generic versions of Lantus and Lantus SoloSTAR, co-developed with
Biocon, is under active review by the U.S. Food and Drug
Administration.
Mylan CEO Heather
Bresch commented, "For years, Mylan has been investing
in the development of a more affordable generic to insulin glargine
for diabetes patients. The PTAB's favorable ruling that invalidates
two Sanofi Lantus® formulation patents is an important step forward
in our journey to help address the needs of nearly 30 million
Americans living with diabetes. We take seriously the
responsibility to improve insulin access and are honored to be a
part of the solution that will bring much-needed competition to
this critical market."
In October 2017, Sanofi initiated
patent infringement litigation against Mylan's NDA in the United States District Court for the
District of New Jersey that
includes these two formulation patents listed as covering Lantus as
well as other patents listed as covering the Lantus SoloSTAR
injection pen. That litigation is pending, and no trial date has
been set.
Sanofi's total IQVIA sales for the 12 months ending Oct. 31, 2018, were approximately $2.14 billion for Lantus 100 Units/mL and about
$4.39 billion for Lantus
SoloSTAR.
This press release includes statements that constitute
"forward-looking statements", including with respect to regulatory
review and approval, and the outcome of pending litigation. 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: success of clinical trials and our or our partners'
ability to execute on new product opportunities; any regulatory,
legal or other impediments to our or our partners' ability to bring
products to market; other risks inherent in product development;
the scope, timing, and outcome of any ongoing legal proceedings,
including government investigations, and the impact of any such
proceedings on our or our partners' businesses; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations, in
the United States and abroad; the
impact of competition; strategies by competitors or other third
parties to delay or prevent product introductions; the effect of
any changes in our or our partners' customer and supplier
relationships and customer purchasing patterns; any other changes
in third-party relationships; changes in the economic and financial
conditions of the businesses of Mylan or its partners;
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.
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 7,500
marketed products around the world, including antiretroviral
therapies on which more than 40% of people being treated for
HIV/AIDS globally 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
approximately 35,000-strong workforce is dedicated to creating
better health for a better world, one person at a time. Learn more
at Mylan.com. We routinely post information that may be
important to investors on our website
at investor.mylan.com.
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SOURCE Mylan N.V.