HERTFORDSHIRE, England and
PITTSBURGH, Dec. 14, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced that the U.S. Patent and Trademark
Appeal Board (PTAB) has instituted inter partes review (IPR)
proceedings on all claims against two Orange Book-listed patents,
U.S. Patent Nos. 7,476,652 and 7,713,930, owned by Sanofi for
Lantus® (insulin glargine injection) 100 Units/mL. Mylan's
505(b)(2) New Drug Application (NDA) for Insulin Glargine in vial
and pen dosage forms is under active review with the U.S. Food and
Drug Administration. Lantus® and Lantus® Solostar® are prescription
medicines indicated for improving glycemic control in adult
patients with diabetes mellitus.
Mylan CEO Heather Bresch
commented, "The PTAB's decision to institute IPR proceedings
against the two Orange Book-listed patents for Lantus is another
step forward in our ongoing efforts to bring an interchangeable
insulin glargine to diabetes patients as soon as possible. There
are more than 29 million people in the U.S. living with diabetes
who deserve access to more affordable treatment options. As a
leading producer of oral diabetes medicines, we are deeply
committed to this patient community and believe bringing lower-cost
alternatives to Lantus and Lantus SoloSTAR will fulfill a critical
medical need."
In October, 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 Lantus
patents.
Total IQVIA sales for the 12 months ending Oct. 31, 2017, were approximately $2.74 billion for Lantus 100 Units/mL and about
$4.98 billion for Lantus
SoloSTAR.
This press release includes statements that constitute
"forward-looking statements," including with regard
to the PTAB's decision to institute IPR proceedings
against the two Orange Book-listed patents for Lantus being another
step forward in Mylan's ongoing efforts to bring an interchangeable
insulin glargine to diabetes patients as soon as possible. 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
products; any regulatory, legal, or other impediments to Mylan's or
its partners' ability to bring products to market; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; 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; 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.
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 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. 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.