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Japan’s Ministry of Health, Labour and Welfare approves Vemlidy® for patients with chronic hepatitis B

December 19, 2016

A once-daily treatment that demonstrated comparable efficacy with improved renal and bone laboratory safety parameters compared to tenofovir disoproxil fumarate (TDF)

FOSTER CITY, Calif., Dec. 19, 2016– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Vemlidy® (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

Vemlidy is a novel targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate (TDF) 300mg. Data show that Vemlidy has greater plasma stability and delivers tenofovir to hepatocytes more efficiently compared to TDF. As a result, Vemlidy can be given at a lower dose, reducing the concentration of tenofovir in the bloodstream. Vemlidy has also shown improvements in renal and bone laboratory safety parameters compared to TDF.

“It is very exciting that a new treatment with improvements in renal and bone safety parameters is now approved for patients with chronic hepatitis B. This is an important advancement, as these patients often require lifelong therapy,” said Namiki Izumi, MD, the President of Musashino RedCross Hospital.

Vemlidy’s approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and treatment-experienced adult patients with HBeAg-negative and HBeAg-positive chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either Vemlidy or TDF, and Study 110 randomized and treated 873 HBeAg-positive patients with either Vemlidy or TDF. Study 108 enrolled 27 patients from 11 sites in Japan and Study 110 enrolled 46 patients from 16 sites in Japan. Both studies met their primary endpoint of non-inferiority to TDF based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.

In an integrated analysis of both studies, patients receiving Vemlidy demonstrated improvements in bone and renal laboratory parameters compared to those treated with TDF. Patients in the Vemlidy arm also experienced numerically higher rates of normalization of serum alanine aminotransferase (ALT) levels.

Vemlidy and TDF were generally well-tolerated by patients in both studies and discontinuations due to adverse events were 1% and 1.2%, respectively. In both studies, the most commonly reported adverse events included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or TDF.

“There are currently more than one million people in Japan chronically infected with hepatitis B, and we believe Vemlidy is an important option for patients living with this disease,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development, and Chief Scientific Officer. “We have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety profile of Vemlidy, and we look forward to making the medication available in Japan soon.”

Gilead is now preparing to launch Vemlidy as quickly as possible.

In Japan, TDF is sold by GlaxoSmithKline K.K.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Original Article