HERTFORDSHIRE, England and
PITTSBURGH, March 20, 2017
/PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global
pharmaceutical company, today announced receipt of tentative
approval from the U.S. Food and Drug Administration under the U.S.
President's Emergency Plan for AIDS Relief (PEPFAR) for its
New Drug Application for Efavirenz, Lamivudine and Tenofovir
Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400").
TLE400, an antiretroviral (ARV) fixed-dose combination, will be
available in developing countries as a first-line regimen for
people being treated for HIV/AIDS.
Mylan's TLE400 is formulated with a 400 mg dose of Efavirenz,
which is less than the standard dose of 600 mg. The Kirby
Institute's ENCORE1 trial1, which used drugs provided by
Mylan and Gilead Sciences, showed that a reduced dose of 400 mg
Efavirenz is non-inferior to a dose of 600 mg, when combined with
Tenofovir and Emtricitabine during 48 weeks in ART-naive adults
with HIV-1 infection. TLE400 was recommended by the World Health
Organization in 2016 as an alternative for first-line therapy for
adults living with HIV.2
"Mylan has a strong and sustained commitment to expand access to
treatment for HIV/AIDS and other diseases in developing countries.
We have nine independent sites engaged in the production and supply
of ARV products, ensuring multiple redundancies so we can maintain
continuous supply," commented Mylan President Rajiv Malik. "TLE400 is another example of our
work to partner with leading global health organizations to
innovate and adapt our medicines to meet the unique needs of people
living in these settings, in order to accelerate access and to
improve treatment outcomes."
There are approximately 37 million people living with
HIV/AIDS3 around the world, with the vast majority
living in developing countries. Mylan has invested $250 million in expanding its ARV production
capacity, enabling the company to produce 4 billion ARV tablets and
capsules every year.
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 market a
growing portfolio of approximately 7,500 products around the world,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world 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.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
availability of TLE400 in developing countries as a first-line
regimen for people being treated for HIV/AIDS; TLE400 being a key
addition to Mylan's Infectious Disease franchise and the fight
against HIV/AIDS; offering a reduced dosage medicine without
compromising efficacy; and Mylan's ability to produce 4 billion ARV
tablets and capsules every year. 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: any changes in or
difficulties with Mylan's or its partners' ability to develop,
manufacture, and commercialize products; any regulatory, legal, or
other impediments to Mylan's or its partners' ability to bring
products to market; 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;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad;
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.
1 Efficacy of 400 mg efavirenz versus standard 600 mg
dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a
randomised, double-blind, placebo-controlled, non-inferiority
trial;
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62187-X/abstract
2 WHO, Consolidated guidelines on the use of
antiretroviral drugs for treating and preventing HIV infection;
http://www.who.int/hiv/pub/arv/arv-2016/en/
3 UNAIDS, AIDS By the Numbers;
http://www.unaids.org/sites/default/files/media_asset/AIDS-by-the-numbers-2016_en.pdf
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SOURCE Mylan N.V.