HERTFORDSHIRE,
England and PITTSBURGH, Dec.
11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL)
today announced that Teva has dismissed its pending district
court litigation against Mylan regarding Mylan's Glatiramer Acetate
Injection 40 mg/mL, the first generic version of
Copaxone® 40 mg/mL. The litigation involved two
non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and
9,763,993, relating to the final sterile filtration step
in the manufacturing process for glatiramer
acetate products.
Teva dropped litigation on these patents after the U.S.
District Court for the District of Delaware issued a decision adopting Mylan's
interpretation of the patents' claims. In addition, Teva has agreed
to withdraw the Irish equivalent to these patents from the recently
filed proceeding in Ireland.
After the dismissals, Teva's only remaining patent
challenges in the U.S. and Ireland
against Mylan's Glatiramer Acetate Injection 40mg/mL relate to the
three-times-a-week dosing regimen, which Mylan has already
successfully invalidated at the U.S. District Court for
Delaware, the U.S. Patent Trial
and Appeal Board and the United
Kingdom's High Court of Justice. Teva is appealing these
decisions.
We are extremely proud to be the first company to offer MS
patients in the U.S. our Glatiramer Acetate Injection 40 mg/mL as
an alternative to Teva's Copaxone three-times-a-week
formulation. The ruling and case dismissal give us even greater
confidence in our ability to continue providing this important
product to thousands of MS patients nationwide who are living with
this very difficult disease and in need of a more affordable
treatment option.
In early October, Mylan received FDA approval and launched
its Glatiramer Acetate Injection 40 mg/mL for three-times-a-week
injection, an AP-rated, substitutable generic version of Teva's
Copaxone 40 mg/mL. According to the FDA approval letter, Mylan was
one of the first applicants to submit a substantially complete
Abbreviated New Drug Application for Glatiramer Acetate Injection,
40 mg/mL, containing a Paragraph IV certification.
Copaxone® is the most prescribed MS treatment for
relapsing forms of MS in the U.S. with brand sales for the 20 mg/mL
dose of approximately $667 million
and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending
Oct. 31, 2017, according to IQVIA.
Approximately 400,000 individuals in the U.S. have MS and relapsing
MS accounts for 85% of initial MS diagnoses.
This press release includes statements that constitute
"forward-looking statements," including with regard to: the launch
of Mylan's Glatiramer Acetate Injection products;
and the ruling and case dismissal giving Mylan even
greater confidence in its ability to continue providing this
important product to thousands of MS patients nationwide who are
living with this very difficult disease and in need of a more
affordable treatment
option. 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: changes in healthcare and pharmaceutical laws and
regulations in the U.S. and abroad; actions and decisions of
healthcare and pharmaceutical regulators; determinations
by health insurance companies regarding coverage for
Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; any regulatory,
legal, or other impediments to Mylan's ability to bring Glatiramer
Acetate Injection 20 mg/mL and 40 mg/mL to market, including
ongoing and unresolved allegations of patent infringement around
our launch of Glatiramer Acetate Injection 40 mg/mL; any changes in
or difficulties with Mylan's or its partners' inventory of, and
ability to manufacture and distribute, Glatiramer Acetate Injection
20 mg/mL and 40 mg/mL to meet anticipated demand; the potential
impact of any change in patient access to or demand for Glatiramer
Acetate Injection 20 mg/mL and 40 mg/mL; the scope, timing, and
outcome of any ongoing legal proceedings, including but not limited
to government investigations, and the impact of any such
proceedings on Mylan's or its partners' business; the impact of
competition; strategies by competitors or other third parties to
delay or prevent product introductions, including Glatiramer
Acetate Injection 20 mg/mL and 40 mg/mL; changes in the economic
and financial conditions of the businesses of Mylan or its
partners; 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 any statements herein 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.