POTTERS BAR, England and
HYDERABAD, India, May 4, 2015 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL) today announced that its subsidiary, Mylan
Pharmaceuticals Private Limited, has launched Gilead Sciences'
Sovaldi (sofosbuvir 400mg tablets) in India. Sovaldi is indicated for the treatment
of chronic hepatitis C infection, a blood-borne infectious disease,
as a component of a combination antiviral treatment regimen. It is
estimated that approximately 12 million people are chronically
infected with hepatitis C in India.
In February 2015, Gilead appointed
Mylan as its exclusive distributor of Sovaldi in India. Mylan President Rajiv Malik commented, "Mylan has a
long-standing history of partnering with Gilead to tackle key
public health issues in India and
around the world, beginning with expanding access to high quality,
affordable HIV/AIDS antiretrovirals and now extending our
partnership to include hepatitis C treatments. We are proud to
continue our work together with the launch of Sovaldi as it
supports our joint commitment to meeting the unmet medical needs of
patients in India."
"We are pleased to bring this important therapeutic advance to
patients living with hepatitis C in India. Today marks an important milestone in
Gilead's ongoing effort to make its hepatitis C medicines
accessible to as many patients, in as many places, as quickly as
possible," said Gregg Alton,
Executive Vice President, Corporate and Medical Affairs, Gilead
Sciences.
Sovaldi is sold by Mylan's dedicated sales force as part of its
Hepato Care segment.
Additional hepatitis C arrangements with Gilead include:
- A licensing and technology transfer agreement that grants Mylan
the non-exclusive rights to manufacture and distribute generic
sofosbuvir and generic ledipasvir/sofosbuvir and, upon FDA
approval, the investigational NS5A inhibitor GS-5816 and single
tablet regimen of sofosbuvir/GS-5816 in 91 developing
countries
- An exclusivity for distribution of Gilead's brand
Harvoni® (ledipasvir 90mg/sofosbuvir 400 mg tablets) in
India
This press release includes statements that constitute
"forward-looking statements," including with regard to sales of
products, product approvals and 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 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 around 1,400 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 about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com
Sovaldi® and Harvoni® are registered
trademarks of Gilead Sciences
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SOURCE Mylan N.V.