Mylan Launches Gilead Sciences' Sovaldi® Tablets in India

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.

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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
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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.

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