PITTSBURGH and HYDERABAD, India, Jan.
26, 2015 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Laboratories Limited is
expanding its hepatitis C licensing agreement with Gilead Sciences,
Inc. to include the non-exclusive rights to manufacture and
distribute the investigational NS5A inhibitor GS-5816 and single
tablet regimen of sofosbuvir(Sovaldi®)/GS-5816, once
approved, in 91 developing countries. The single tablet regimen is
being evaluated in Phase 3 clinical studies for the treatment of
all six genotypes of hepatitis C.
If approved by regulatory authorities, the sofosbuvir/GS-5816
regimen would become the first all-oral single tablet regimen for
all hepatitis C genotypes. A pan-genotypic therapeutic option is
particularly important for developing countries, where genotype
testing is often unreliable or not readily available.
Mylan President Rajiv Malik said,
"We are proud to partner with Gilead, once again, in our joint
effort to quickly expand access to high quality, affordable
medications to the more than 100 million people living with
hepatitis C in developing countries.1 The potential to
offer the sofosbuvir/GS-5816 regimen is particularly exciting, as
it is an innovative compound that is being studied to treat all
hepatitis C genotypes – a medical advancement that could
significantly increase access to treatment."
This agreement is in addition to the licensing and technology
transfer agreement that Mylan entered into with Gilead in
September 2014, which grants Mylan
the non-exclusive rights to manufacture and distribute sofosbuvir
and ledipasvir/sofosbuvir 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.
About GS-5816
The single tablet regimen of sofosbuvir/GS-5816 is an
investigational agent and its safety and efficacy have not been
established. Phase 3 studies evaluating the combination of GS-5816
and sofosbuvir are currently underway, with data anticipated in the
second half of 2015.
About Sofosbuvir
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).
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 product
approvals and sales, 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. "Guidelines for the
screening, care and treatment of persons with hepatitis C
infection." April 2014.
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SOURCE Mylan Inc.