HERTFORDSHIRE, England,
BANGALORE, India and PITTSBURGH, Dec. 1,
2015 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL)
today announced that it expects to be the first to launch, upon
regulatory approval and for developing country markets funded by
international donors, TLE400 (Tenofovir Disoproxyl Fumarate 300 mg
+ Lamivudine 300 mg + Efavirenz 400 mg) for $99 per patient, per year. Mylan partnered with
the Clinton Health Access Initiative (CHAI) to develop TLE400. The
significantly reduced price could generate savings of tens of
millions of dollars for national AIDS programs that aim to
double the 15 million people on antiretroviral (ARV) treatment in
developing countries. Mylan expects to file a new drug application
(NDA) for TLE400 with the U.S. Food and Drug Administration (FDA)
in the first quarter of 2016.
The World Health Organization (WHO) is releasing new ARV
guidelines that incorporate, for the first time, TLE400 as an
alternative first-line regimen for patients intolerant to the most
commonly prescribed combinations today, which use Efavirenz 600 mg.
Though there are insufficient data for WHO to recommend TLE400
in persons with tuberculosis co-infection or women who are
pregnant, related studies are planned or underway. These studies
are being funded by Mylan, in partnership with CHAI, to explore the
maximum potential benefits of the product to patients living with
HIV.
FDA tentative approval or prequalification by the World Health
Organization is a prerequisite for the purchase of ARVs using funds
from international donors such as the Global Fund to Fight AIDS,
Tuberculosis and Malaria and the U.S. President's Emergency Plan
for AIDS Relief (PEPFAR). Mylan expects to be the first
company to file TLE400 with FDA and/or WHO and anticipates being
the first to market the product for donor-funded procurement in
developing countries.
Mylan also is a staunch supporter of revised guidelines from the
WHO recommending that anyone who tests positive for HIV be treated
with ARVs as soon as possible following diagnosis. In addition, the
guidelines recommend that those who are at high risk of being
infected also be offered preventive therapy.
Mylan CEO Heather Bresch said,
"This World AIDS Day is an opportunity to reflect on the tremendous
progress that has been made in the fight against HIV/AIDS, in
particular, the 15 million people in developing countries who now
have access to ARV treatment. However, today also is a time to
recognize that there is much more work to be done to increase
access to treatment and to end this epidemic.
Mylan President Rajiv Malik
added, "Mylan applauds the new WHO guidelines, as we have long been
an advocate for treatment soon after diagnosis to help ensure
better health outcomes and reduce transmission. Mylan has a
longstanding commitment of bringing to market innovative, high
quality, affordable products to help satisfy the unmet needs of
HIV/AIDS patients around the world – from our pediatric,
heat-stable and combination ARV products, to our recent launch of
an at-home HIV test in France, to
the expected launch of TLE400 upon approval – and today
we reaffirm our unwavering commitment to stemming the tide of
HIV/AIDS."
Mylan currently supplies life-saving ARV medicines to nearly 50%
of the men, women and children living with the disease and
accessing treatment in more than 100 developing countries. Its
comprehensive ARV portfolio includes 14 APIs and 50 finished dosage
forms in first-line, second-line and pediatric formulations.
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 1,400 generic and branded
pharmaceuticals, including antiretroviral therapies on which nearly
50% of people being treated for HIV/AIDS in the developing world
depend. We market our products in approximately 165 countries and
territories. Our global R&D and manufacturing platform includes
more than 50 facilities, and we are one of the world's largest
producers of active pharmaceutical ingredients. Every member of our
more than 30,000-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 Mylan's
statements that it expects to be the first to launch TLE400 for
$99 per patient, per year; that this
significantly reduced price could generate savings of tens of
millions of dollars for national AIDS programs that aim to double
the 15 million people on ARV treatment in developing countries;
that it expects to file an NDA for TLE400 with the FDA in the first
quarter of 2016; that though there are insufficient data for WHO to
recommend TLE400 in persons with tuberculosis co-infection or women
who are pregnant, related studies are planned or underway; about
the studies being funded by Mylan in partnership with CHAI to
explore the maximum potential benefits of the product to residents
living with HIV; that it expects to be the first company to file
TLE400 with the FDA and/or WHO and anticipates being the first to
market the product for donor-funded procurement in developing
countries; and that it is committed to bringing to market
innovative, high quality, affordable products to help satisfy the
unmet needs of HIV/AIDS patients around the world and to stemming
the tide of HIV/AIDS. 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 our
inventory of, and our ability to manufacture and distribute, TLE400
and other ARVs; the effect of any changes in our 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; the scope, timing, and outcome of any ongoing legal
proceedings and the impact of any such proceedings on our business;
any regulatory, legal, or other impediments to our ability to bring
our 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; our ability to
protect our intellectual property and preserve intellectual
property rights; other uncertainties and matters beyond the control
of management; and the other risks detailed in the company's
filings with the Securities and Exchange Commission. The company
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.