HERTFORDSHIRE, England and
PITTSBURGH, June 18, 2020 /PRNewswire/ -- Mylan
N.V. (NASDAQ: MYL) today announced that the U.S. District
Court for the Northern District of West
Virginia invalidated Biogen's Tecfidera® patent,
U.S. Patent No. 8,399,514, for lack of written description. The
᾿514 patent claimed methods of treating multiple sclerosis (MS)
using a dose of 480 mg/day of dimethyl fumarate delayed release
capsules. Today's decision clears the way for Mylan's launch of its
dimethyl fumarate product upon the receipt of FDA approval. The
'514 patent could have otherwise delayed generic competition until
2028.
Mylan CEO Heather Bresch
commented: "Today's win is significant in that it brings Mylan one
step closer to providing expanded treatment options for the
thousands of Americans living with relapsing forms of MS. The
District Court decision clears the legal pathway for us to bring
our dimethyl fumarate product to market, and we are working with
the FDA to accelerate our regulatory approval target action date,
which currently is November 16. Once
approved and launched, we believe our generic Tecfidera will
potentially be the first generic of any MS treatment in an oral
solid dosage form available to patients in the U.S., further
advancing our commitment to provide a broad portfolio of central
nervous system medicines, which already includes glatiramer acetate
injection."
Mylan President Rajiv Malik
commented: "Mylan continues to address unmet patient needs across
the value chain. Bringing a product like generic Tecfidera to
market requires not only our extensive scientific and commercial
expertise, but also our unwavering commitment to access through
overcoming potential legal barriers to reach patients. We look
forward to bringing this important medicine to market as soon as
possible, pending final FDA approval."
Tecfidera (dimethyl fumarate) delayed-release capsules are used
to treat adults with relapsing forms of MS. Mylan believes it is
one of the first companies to have filed a substantially complete
Abbreviated New Drug Application (ANDA) containing a Paragraph IV
certification for a dimethyl fumarate product and expects to be
eligible for 180 days of marketing exclusivity in the U.S. upon
final FDA approval. Mylan's ANDA is pending with the U.S. Food and
Drug Administration (FDA).
Biogen's total IQVIA sales in the U.S. for the 12 months ending
April 30, 2020, were approximately
$3.78 billion for Tecfidera.
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
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 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.
Forward-Looking Statements
This press release
includes statements that constitute "forward-looking statements,"
including with regard to today's decision clearing the way for
Mylan's launch of its dimethyl fumarate product upon the receipt of
FDA approval; that today's win is significant in that it brings
Mylan one step closer to providing expanded treatment options for
the thousands of Americans living with relapsing forms of MS; that
the District Court decision clears the legal pathway for us to
bring our dimethyl fumarate product to market, and we are working
with the FDA to accelerate our regulatory approval target action
date, which currently is November 16;
that once approved and launched, we believe our generic Tecfidera
will potentially be the first generic of any MS treatment in an
oral solid dosage form available to patients in the U.S., further
advancing our commitment to provide a broad portfolio of central
nervous system medicines, which already includes glatiramer acetate
injection; that we look forward to bringing this important medicine
to market as soon as possible, pending final FDA approval; and that
Mylan believes it is one of the first companies to have filed a
substantially complete ANDA containing a Paragraph IV certification
for a dimethyl fumarate product and expects to be eligible for 180
days of marketing exclusivity in the U.S. upon final FDA
approval. 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 the potential widespread and highly
uncertain impact of public health outbreaks, epidemics and
pandemics, such as the COVID-19 pandemic; 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.
