HERTFORDSHIRE, England
and BANGALORE, India and
PITTSBURGH, Jan. 7, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced that its subsidiary, Mylan
Pharmaceuticals Private Limited, has launched generic Harvoni®
(Ledipasvir 90 mg/Sofosbuvir 400 mg) tablets under the brand name
MyHep LVIR™ in India.
There are approximately 12 million people who are chronically
infected with Hepatitis C in India
and most do not know they are infected.1 The
Ledipasvir/Sofosbuvir combination is indicated for the treatment of
Hepatitis C infection and offers a simplified Hepatitis C treatment
regimen that eliminates the need for interferon and ribavirin. The
product also is a single-tablet regimen and requires a therapy
course of just 12 weeks. Harvoni® has exhibited high cure rates and
a tolerable side effect profile across a range of patient
populations.
Mylan President Rajiv Malik said,
"Mylan recognizes the urgent need to expand access to high quality,
affordable Hepatitis C treatment options in India, where roughly 12 million people are
infected with the virus. MyHep LVIR™ is an important
addition to our growing Hepato Care segment in India that gives us the opportunity to offer
patients the potential to be cured through a transformative and
simplified single tablet, once-daily treatment regimen. Moreover,
consistent with our commitment to create better health for a better
world, we are introducing various educational initiatives in
India to raise awareness of the
disease and its treatment options."
The launch of MyHep LVIR™ follows the successful
launch of generic Sofosbuvir in India under the brand name MyHep™
in April 2015. In September 2014, Mylan entered into a licensing
and technology transfer agreement with Gilead granting Mylan the
non-exclusive rights to manufacture and distribute generic
Sofosbuvir and Ledipasvir/Sofosbuvir tablets in 101 developing
countries, including India.
Mylan also entered into an agreement with Gilead in February 2015 as the exclusive distributor of
Gilead's branded Sovaldi® (Sofosbuvir 400 mg) and Harvoni® tablets
in India. Mylan launched Sovaldi®
in India in May
2015.
This press release includes statements that constitute
"forward-looking statements," including with regard to statements
that MyHep LVIR™ is an important addition to
Mylan's growing Hepato Care segment in India that gives Mylan the opportunity to
offer patients the potential to be cured through a transformative
and simplified single tablet, once-daily treatment regimen; and
that consistent with Mylan's commitment to create better health for
a better world, it is introducing various educational initiatives
in India to raise awareness of the
disease and its treatment options. 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 Mylan's ability to develop, manufacture, and
commercialize Hepato Care products; the impact of competition and
the use of legal, regulatory and legislative strategies by
competitors or other third parties to delay or prevent our
introduction of new products; changes in economic and financial
conditions; changes in third party relationships; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations, in
the United States and abroad;
risks associated with international operations; other uncertainties
and matters beyond the control of management; and the other risks
detailed in Mylan's filings with the Securities and Exchange
Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
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.
- World Health Organization. Hepatitis C Surveillance and
Control.
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html.
Accessed on December 25, 2015.
HARVONI and SOVALDI are trademarks of Gilead Sciences, Inc.
Photo - http://photos.prnewswire.com/prnh/20160106/319968
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-launches-generic-harvoni-ledipasvirsofosbuvir-under-the-brand-name-myhep-lvir-in-india-300200910.html
SOURCE Mylan N.V.