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Jul 27, 2017

Mylan Launches MyHep AllTM in India

Mylan Launches MyHep All™ in India

MyHep All™ is a fixed-dose combination of
Velpatasvir 100 mg/Sofosbuvir 400 mg Tablets

HERTFORDSHIRE, England and PITTSBURGH – July 27, 2017 – Mylan Pharmaceuticals Private Limited (a subsidiary of Mylan N.V.) today announced the launch of Velpatasvir 100 mg/Sofosbuvir 400 mg Tablets under the brand name MyHep All™ in India. MyHep All™ is a fixed-dose combination tablet indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, including all six major HCV genotypes. A Velpatasvir 100 mg /Sofosbuvir 400 mg combination product is currently sold by Gilead Sciences in other markets under the brand name EPCLUSA®.

HCV is a bloodborne virus commonly transmitted through unsafe injection practices, inadequate sterilization of medical equipment, and the transfusion of unscreened blood and blood products. HCV also can be transmitted sexually and can be passed from an infected mother to her baby.

HCV can cause both acute and chronic infections. Approximately 55–85% of those infected will develop chronic HCV infection. People with chronic HCV infection are often undiagnosed because the infection can remain asymptomatic for decades. In many instances, symptoms develop because of serious liver damage.

It’s estimated that more than 70 million people around the world have chronic hepatitis C infection, and nearly 400,000 people die each year from hepatitis C-related liver diseases.

"Chronic hepatitis C is a significant public health burden in India. When we launched Mylan’s Hepato Care division in January 2015, we did so to increase access to critical, life-saving medicines for patients with chronic HCV and other liver-related conditions,” commented Mylan President Rajiv Malik. “The launch of the fixed-dose combination of MyHep All™ is part of this mission and will help patients adhere to their chronic HCV treatment regimen. Mylan has a longstanding, ongoing commitment to accelerate access and to improve treatment outcomes in India and other developing countries.”

The MyHepAll™ launch follows Mylan’s successful January 2016 launch of MyHep LVIR™ (Ledipasvir/Sofosbuvir combination) in India. Mylan has the non-exclusive right to manufacture and distribute Velpatasvir/Sofosbuvir in approximately 100 developing countries via a license agreement from Gilead Sciences.

This press release includes statements that constitute "forward-looking statements," including with regard to the ability of MyHep All™ to help patients adhere to chronic HCV treatment regimens and Mylan’s ongoing commitment to accelerate access and to improve treatment outcomes in India and other developing countries.  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 or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States, India 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.