PITTSBURGH and HYDERABAD, India, Dec.
1, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Laboratories Limited has
entered into an agreement with Gilead Sciences, Inc. under which
Mylan has licensed the non-exclusive rights to manufacture and
distribute Tenofovir Alafenamide (TAF) as both a single agent
product and in combination with other drugs. Tenofovir Alafenamide
(TAF) is an investigational antiretroviral drug for the treatment
of HIV-1 infection.
The license being granted to Mylan extends to 112 countries,
which together account for more than 30 million people living with
HIV, representing 84% of those infected globally.1
Mylan CEO Heather Bresch said,
"Mylan's mission is to provide the world's 7 billion people access
to high quality medicines and set new standards in health care. By
working with partners like Gilead to help ensure access to
innovative new products such as Tenofovir Alafenamide (TAF) in the
countries hardest hit by this disease, we can help stem the tide of
HIV/AIDS around the world."
As part of the licensing agreement, on U.S. Food and Drug
Administration (FDA) approval, Mylan will receive a technology
transfer from Gilead, enabling the company to manufacture low-cost
versions of Tenofovir Alafenamide (TAF), if approved as a single
agent or in approved combinations containing Tenofovir Alafenamide
(TAF) for developing markets.
Phase III trials by Gilead Sciences met their primary objective
supporting the potential for Tenofovir Alafenamide (TAF) to provide
a new treatment option for individuals living with HIV.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
company's strategy, future growth and performance. 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: the impacts of
competition; changes in economic and financial conditions of the
company's business; strategies by competitors or other third
parties to delay or prevent product introductions; risks inherent
in legal and regulatory processes; risks associated with
international operations; 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.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. 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 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. Learn more at mylan.com.
1 Source: www.unaids.com
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SOURCE Mylan Inc.