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Dec 7, 2017

Mylan Launches HepBest in India

Mylan Launches HepBestTM, First Drug Approved in Eight Years for Management of Chronic Hepatitis B Infection in India

 Bengaluru, India, December 7, 2017 – Mylan Pharmaceuticals Private Limited today launched HepBestTM 25 mg (tenofovir alafenamide, TAF), a once-daily tablet for the treatment of chronic hepatitis B in adults. According to World Health Organization (WHO) estimates, more than 2 billion people worldwide are infected with the hepatitis B virus (HBV), of which more than 240 million have chronic liver infection.[i] These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer.[ii] HepBestTM (TAF) is the first drug in eight years to be approved for the management of chronic hepatitis B in India.

TAF demonstrates comparable efficacy with an enhanced renal and bone safety profile as compared to the earlier formulation of tenofovir (tenofovir disoproxil fumarate). TAF also has greater plasma stability[iii], which ensures efficient drug delivery to the site of action.

Commenting on the launch, Rakesh Bamzai, President, India and Emerging Markets said, “India has an estimated 40 million HBV carriers, of which 15% to 25% could go on to suffer from cirrhosis and liver cancer.[iv] Mylan continues to be in the forefront of introducing new treatment regimens for the management of hepatitis in India. By bringing the best-in-class drug for hepatitis B management, HepBestTM, to India, Mylan hopes to provide care for chronic hepatitis B patients and improve overall management of the disease.”

In 2014, Mylan signed an agreement with Gilead to enhance access to TAF-based HIV treatments in developing countries. As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan received a technology transfer from Gilead, enabling it to manufacture low-cost versions of TAF.

[i] Tackling the Hepatitis B Disease Burden in India: Pankaj Puri, J Clin Exp Hepatol. 2014 Dec; 4(4): 312–319.

[ii] Tackling the Hepatitis B Disease Burden in India: Pankaj Puri, J Clin Exp Hepatol. 2014 Dec; 4(4): 312–319.
[iii] Hsu YC, Wei MT, Nguyen MH. Tenofovir alafenamide as compared to tenofovir disoproxil fumarate in the management of chronic hepatitis B with recent trends in patient demographics. Expert Rev Gastroenterol Hepatol. 2017 Nov;11(11):999-1008.  
[iv] Tackling the Hepatitis B Disease Burden in India: Pankaj Puri, J Clin Exp Hepatol. 2014 Dec; 4(4): 312–319.