PITTSBURGH and HYDERABAD, India, Sept.
15, 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 been licensed the non-exclusive rights to manufacture and
distribute sofosbuvir and the investigational single tablet regimen
of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is
marketed by Gilead under the brand name Sovaldi®.
The countries within the agreement account for more than 100
million people living with hepatitis C globally representing 54% of
the total global infected population.1
Mylan CEO Heather Bresch said,
"Hepatitis C is a growing public health problem in developing
countries, with Central and East
Asia and North Africa among
the regions most affected by this
disease.2 Unfortunately, patients in
these regions often lack access to critical and effective
treatments. This agreement with Gilead will allow Mylan to provide
early access to a more affordable version of Sovaldi, helping to
meet the unmet medical needs of the millions of patients in
developing countries who do not currently have access to this
life-saving medicine."
Under the licensing agreement, Mylan will receive a technology
transfer enabling the company to manufacture low-cost versions of
the medicines for developing markets.
Sofosbuvir was approved under the trade name Sovaldi® by the
U.S. Food and Drug Administration (FDA) in December 2013 based on clinical studies that
showed sofosbuvir, in combination with other agents, achieved very
high cure rates with a course of treatment as short as 12 weeks
depending on viral genotype. Sofosbuvir also was approved by the
European Commission in January 2014
and is a recommended treatment option in the World Health
Organization's first hepatitis C treatment guidelines (released in
April 2014). The FDA and the European
Medicines Agency are currently reviewing Gilead's applications for
a single tablet regimen of ledipasvir/sofosbuvir; it is an
investigational agent and its safety and efficacy have not been
established.
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. But don't take our word for
it. See for yourself. See inside. mylan.com
1 World Health Organization. "Guidelines for the
screening, care and treatment of persons with hepatitis C
infection." April 2014.
2 World Health Organization. "Hepatitis C
– Key Facts." http://www.who.int/mediacentre/factsheets/fs164/en/.
Accessed on Sept. 4, 2014.
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SOURCE Mylan Inc.