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.
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).
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.
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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 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
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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