$GILD Received Japanese Approval for its Hepatitis B Drug

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Blog Coverage Gilead Sciences Received Japanese Approval for its Hepatitis B Drug

One of Gilead Sciences’ competitors within the Biotechnology space, XBiotech Inc. (NASDAQ: XBIT), reported on November 15, 2016, its results for the third quarter ended September 30, 2016. AWS will be initiating a research report on XBiotech in the coming days.

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What it Vemlidy?

Gilead’s 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. Gilead stated that data shows that Vemlidy has greater plasma stability and delivers tenofovir to hepatocytes more efficiently compared to TDF (In Japan, TDF is sold by GlaxoSmithKline K.K.). 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. In November 2016, Vemlidy was approved for marketing in the USA and is also recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

“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 of 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.”

Vemlidy Studies 108 and 110

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. The 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 levels. 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.

Gilead announced that it is now preparing to launch Vemlidy in the Japanese market as early as possible.

Stock Performance

On Monday, December 19th, 2016, the stock closed the trading session at $74.40, slightly rising 0.40% from its previous closing price of $74.10. A total volume of 8.19 million shares have exchanged hands. Gilead Sciences’ stock is trading at a PE ratio of 6.90 and has a dividend yield of 2.53%. The stock currently has a market cap of $99.94 billion.

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