PITTSBURGH and HYDERABAD, India, Feb.
23, 2015 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its Indian subsidiary, Mylan Pharmaceuticals Private
Limited, has entered into an agreement with Gilead Sciences, under
which Mylan has been appointed as the exclusive distributor of
Sovaldi® (sofosbuvir 400mg tablets) and
Harvoni® (ledipasvir 90mg/sofosbuvir 400 mg tablets) for
the treatment of chronic hepatitis C, in India. As Gilead's exclusive branded medicine
distribution partner, Mylan expects to begin distribution of
Sovaldi in India in Q2 2015.
Sovaldi received regulatory approval in India in January
2015 – the first country in Asia to approve the medicine.
Mylan President Rajiv Malik said,
"Hepatitis C is a growing public health concern, particularly in
developing countries such as India
where access to high quality, effective and affordable treatment
remains a challenge. Mylan is proud to partner with Gilead to
expand access to Sovaldi and Harvoni, life-saving medications that
offer an improvement in the standard of care for the 12 million
hepatitis C patients in India."1
This agreement is in addition to the licensing and technology
transfer agreement that Mylan entered into with Gilead, which
grants Mylan the non-exclusive rights to manufacture and distribute
generic sofosbuvir, ledipasvir/sofosbuvir and, upon approval, the
investigational NS5A inhibitor GS-5816 and single tablet regimen of
sofosbuvir/GS-5816 in 91 developing countries. Mylan also partners
with Gilead on expanding access to high quality, affordable
antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
Sovaldi is the latest addition to Mylan India's new
gastrointestinal segment called Hepato Care. The company also
offers four additional unique and innovative segments – Critical
Care, HIV Care, Women's Care and Oncology.
About Sovaldi
Sovaldi was approved by the U.S. Food
and Drug Administration (FDA) in December
2013 based on clinical studies that showed, in combination
with other agents, the drug achieved very high cure rates with a
course of treatment as short as 12 weeks depending on viral
genotype. Sovaldi 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).
About Harvoni
Harvoni was approved by the US FDA in
October 2014 as a once-daily single
tablet regimen for the treatment of chronic hepatitis C genotype 1
infection in adults.
Private Securities Litigation Reform Act of 1995 — A Caution
Concerning Forward-Looking Statements
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 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 25,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. Learn more at mylan.com
1.
|
World Health
Organization. Hepatitis C Surveillance and Control.
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html.
Accessed on Jan. 15, 2015.
|
Sovaldi and Harvoni are registered trademarks of Gilead
Sciences
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