HERTFORDSHIRE, England and
PITTSBURGH, Feb. 1, 2018 /PRNewswire/ -- Global
pharmaceutical leader Mylan N.V. (NASDAQ, TASE: MYL) today
announced the U.S. launch of Efavirenz Tablets USP, 600 mg, the
first generic version of Bristol-Myers Squibb's Sustiva®. The
product is indicated in combination with other antiretroviral
agents for the treatment of human immunodeficiency virus type 1
infection in adults and in pediatric patients at least 3 months old
and weighing at least 3.5 kg.
Mylan is the world's largest producer of HIV/AIDS drugs, and
more than 40% of the world's 20 million people being treated
worldwide for HIV/AIDS depend on a Mylan antiretroviral product. In
the U.S., there are an estimated 1.1 million people living with
HIV.
"With the launch of Efavirenz, Mylan marks an important
achievement in bringing more affordable treatment options to the
HIV patient community," said Mylan CEO Heather Bresch. "Our global commitment to
improving access to antiretroviral medicines for this important
patient population spans more than a decade, and the U.S. launch
bolsters our leadership in producing high-quality ARVs and
positions us to continue to lead this important category in the
future."
According to the FDA approval letter, Mylan was one of the first
applicants to submit a substantially complete ANDA for Efavirenz
Tablets USP, 600 mg, containing a Paragraph IV certification, and
is eligible for 180 days of generic drug exclusivity. Efavirenz
Tablets USP, 600 mg, had U.S. sales of approximately $113 million for the 12 months ending
Dec. 31, 2017, according to
IQVIA.
Currently, Mylan has 208 ANDAs pending FDA approval representing
approximately $93.2 billion in annual
brand sales, according to IQVIA. Forty-six of these pending ANDAs
are potential first-to-file opportunities, representing
$42.1 billion in annual brand sales,
for the 12 months ending July 31,
2017, according to IQVIA.
Mylan's Commitment to Stemming the Tide of HIV/AIDS
For more than a decade, Mylan has been a leader in providing access
to quality, dependable and affordable ARVs in more than 100
countries around the world. This includes introducing in 2009 the
first generic one-tablet-once-a-day combination for developing
countries – only three years after the originator product launched
in the U.S. Since that time, Mylan has been the first to market
with nearly half of the new products approved under the FDA's U.S.
President's Emergency Plan for AIDS Relief (PEPFAR) program. Mylan
was also the first generic drug maker to develop a heat-stable
version of a drug critical for second-line regimens, and is the
leading supplier of pediatric ARVs, including taste-masked and
dispersible formulations. Mylan has also long been a supporter of
the patient community through the sponsorship of free community
HIV/AIDS testing and clinical research. Learn more about Mylan's
work with infectious disease here. Watch this video to learn more
about Mylan's commitment to people living with HIV/AIDS.
This press release includes statements that constitute
"forward-looking statements," including with regard to Mylan
expanding access to HIV/AIDS medicines; Mylan continuing to be at
the forefront of working to meet the needs of this important
patient community; and Mylan being eligible for 180 days of generic
drug exclusivity. 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: success of clinical trials and our or our
partners' ability to execute on new product opportunities; any
regulatory, legal or other impediments to our or our partners'
ability to bring products to market; other risks inherent in
product development; the scope, timing, and outcome of any ongoing
legal proceedings, including government investigations, and the
impact of any such proceedings on our or our partners' businesses;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad; the impact of
competition; strategies by competitors or other third parties to
delay or prevent product introductions; the effect of any changes
in our or our partners' customer and supplier relationships and
customer purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of
the businesses of Mylan or its partners; 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 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.
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SOURCE Mylan N.V.