HERTFORDSHIRE, England and
PITTSBURGH, March 10, 2020 /PRNewswire/ -- Mylan N.V.
(NASDAQ: MYL) today announced that the U.S. District Court of
New Jersey found the device patent
claims (U.S. Patent No. 9,526,844) asserted by Sanofi against
Mylan's insulin glargine product not infringed and invalid for lack
of written description. Separately, as previously announced,
Sanofi's formulation patents (U.S. Patent No. 7,476,652 and U.S.
Patent No. 7,713,930) were previously affirmed to be invalid by the
Federal Circuit. The '844 and '652 patents were the only
patents being asserted by Sanofi against Mylan's insulin glargine
product.
Mylan CEO Heather Bresch
commented, "Today's decision by the District Court represents a
significant milestone for patient access and Mylan's effort to
bring a more affordable insulin glargine to those living with
diabetes in the U.S. As the cost of diabetes medications continues
to rise, we now are one step closer to being able to meet unmet
patient needs through the launch of our Semglee® insulin
glargine, pending final approval from the U.S. Food and Drug
Administration."
Mylan President Rajiv Malik added, "We are encouraged by today's
legal win on Mylan's insulin glargine and remain very confident in
the strong science behind the product itself. We believe that this
scientific excellence will also be central to our work to bring an
interchangeable product option. We look forward to serving patients
in the U.S. with the same Semglee® that so many others
have come to rely on around the world and adding to our existing
offering of oral solid dose medications for those living with
diabetes."
Malik continued, "Today's outcome illustrates and further adds
to our ability to leverage both our own internal scientific
capabilities as well as those of our partners to bring complex,
higher value chain products to market, delivering innovation to
patients and creating a foundation that will fuel our future
growth."
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. Mylan's 505(b)(2) New Drug
Application (NDA) is under active review by the U.S. Food and Drug
Administration. The product, co-developed with Biocon, has received
regulatory approval in more than 45 countries around the world.
Biocon continues to be confident in its ability to achieve facility
clearance.
Sanofi sells the product in vials (Lantus) and as a disposable
injection pen (Lantus SoloSTAR®). Sanofi's total IQVIA sales for
the 12 months ending Jan. 31, 2020,
were approximately $1.73 billion for
Lantus 100 Units/mL and approximately $4.24
billion for Lantus SoloSTAR.
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 approximately
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.
This press release includes statements that constitute
"forward-looking statements," including with regard to: regulatory
review and approval; the outcome of litigation; that today's
decision by the District Court represents a significant milestone
for patient access and Mylan's effort to bring a more affordable
insulin glargine to those living with diabetes in the U.S.; as the
cost of diabetes medications continues to rise, we now are one step
closer to being able to meet unmet patient needs through the launch
of our Semglee® insulin glargine, which we continue to expect to be
able to bring to market by the middle of this year pending final
approval from the U.S. Food and Drug Administration; that we are
encouraged by today's legal win on Mylan's insulin glargine and
remain very confident in the strong science behind the product
itself; that we believe that this scientific excellence will also
be central to our work to bring an interchangeable product option;
that today's outcome illustrates and further adds to our ability to
leverage both our own internal scientific capabilities as well as
those of our partners to bring complex, higher value chain products
to market, delivering innovation to patients and creating a
foundation that will fuel our future growth; and that Biocon
continues to be confident in its ability to achieve facility
clearance. Because forward-looking statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such
statements. Factors that could cause or contribute to such
differences include, but are not limited to any changes in,
interruptions to, or difficulties with Mylan's or its partners'
ability to develop, manufacture, and commercialize products; 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; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
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.
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SOURCE Mylan N.V.
