HERTFORDSHIRE, England and
PITTSBURGH, Aug. 19, 2020 /PRNewswire/
-- Mylan N.V. (NASDAQ: MYL) today announced the
launch of the first FDA-approved therapeutically equivalent,
substitutable generic of Biogen's Tecfidera® capsules.
Dimethyl fumarate delayed release capsules 120 mg and 240 mg are
indicated for the treatment of relapsing forms of multiple
sclerosis (MS), and are the first generic of any MS treatment in an
oral solid dosage form available to patients in the U.S.
Mylan CEO Heather Bresch said:
"The launch of the first generic Tecfidera is yet another prime
example of Mylan's fundamental commitment to bringing more access
to patients worldwide, in this particular case through our
important continued support of the MS community, while helping to
provide immediate and substantial savings for the U.S. healthcare
system. It also represents another significant achievement for the
many Mylan scientific, regulatory and legal colleagues who continue
to work tirelessly in doing their part to bring important access to
medicines as quickly as possible."
Mylan President Rajiv Malik said:
"Our commitment to the MS community stems all the way back to our
initial investment in 2009 to bring a first generic Copaxone to
market, which we achieved in 2017. Today's launch represents yet
another example of that commitment, by bringing access to the first
generic of Tecfidera. While we are pleased with our accomplishments
to date, we remain equally excited to expand our offerings by
advancing work on a co-developed follow-on product for a
once-monthly glatiramer acetate injection. I too would like to
thank all of my colleagues for their passion and support in
fulfilling our company's mission to expand access to high quality
medicines."
The FDA approval follows Mylan's win in the U.S. District
Court for the Northern District of West
Virginia that invalidated Biogen's Tecfidera®
patent, U.S. Patent No. 8,399,514. Biogen is appealing that
decision.
Biogen's total IQVIA sales in the U.S. for the 12 months ending
June 30, 2020, were approximately
$3.79 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 Statement
This press release includes statements that constitute
"forward-looking statements," including with regard to the approval
and launch of the first generic to Tecfidera; that the launch is
yet another prime example of Mylan's fundamental commitment to
bringing more access to patients worldwide, in this particular case
through our important continued support of the MS community, while
helping to provide immediate and substantial savings for the U.S.
healthcare system; that while we are pleased with our
accomplishments to date, we remain equally excited to expand our
offerings by advancing work on a co-developed follow-on product for
a once-monthly glatiramer acetate injection; the outcome of
litigation; that the FDA approval follows Mylan's win in the U.S.
District Court for the Northern District of West Virginia that invalidated Biogen's
Tecfidera® patent, U.S. Patent No. 8,399,514; and that
Biogen is appealing that decision. 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 completion
of the proposed combination of Mylan and Upjohn Inc., Pfizer Inc.'s
off-patent branded and generic established medicines business, (the
"Combination") on the anticipated timeline or at all, and the
achievement of the anticipated benefits of the Combination; 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.
