Mylan Launches Generic Sofosbuvir Tablets, MyHep™, in India

POTTERS BAR, England and HYDERABAD, India, April 23, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched generic Sofosbuvir 400 mg tablets under the brand name MyHep™ in India. The product is indicated for the treatment of chronic hepatitis C, a blood-borne infectious disease, as a component of a combination antiviral treatment regimen. It affects more than 100 million people in the developing world, including approximately 12 million people who are chronically infected with hepatitis C in India.^1,2

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 in 91 developing countries, including India.

Mylan President Rajiv Malik said, "The launch of Mylan's MyHep offers hope to millions of hepatitis C patients in India who are in need of a high quality, effective and affordable treatment option. We look forward to bringing that same hope to millions of more hepatitis C patients as we expand access to MyHep in the developing world."

MyHep is an important addition to Mylan's growing commercial business in India and is sold by Mylan's dedicated sales force as part of its Hepato Care segment. The company also offers four additional unique and innovative segments – Critical Care, HIV Care, Women's Care and Oncology.

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.

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.
2. World Health Organization. "Guidelines for the screening, care and treatment of persons with hepatitis C infection." April 2014.

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SOURCE Mylan N.V.

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