Blog Coverage Gilead Sciences Hepatitis B Drug Vemlidy Approved by European Medicines Agency

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LONDON, UK / ACCESSWIRE / November 14, 2016 / Active Wall St. blog coverage looks at the headline from Gilead Sciences, Inc. (NASDAQ: GILD) as the company announced on November 11th, 2016, that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (≥ 12 years and ≥ 35 kg body weight). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

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The data included in the application support the use of TAF in treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection. TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at one-tenth the dose of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg. The data demonstrated that as TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, TAF improved certain renal and bone laboratory safety parameters compared to TDF in clinical trials. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The application for TAF includes data from two international Phase 3 studies (Studies 108 and 110) in 1,298 treatment-naïve and treatment-experienced patients with HBV infection. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. The full data from Studies 108 and 110 were presented at the International Liver Congress™ (ILC) earlier this year.

Follow Up from US Approval

The approval from EMA closely follows the approval received by Gilead Sciences, from the U.S. Food and Drug Administration (FDA) on November 10th, 2016, for TAF 25mg for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

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

“Since the mid-1990s, Gilead has been working to improve and simplify care for people living with chronic hepatitis B,” said John Milligan, Ph.D., President and Chief Executive Officer of Gilead Sciences, “Vemlidy is the first medication approved to treat this disease in nearly a decade, and we are excited to offer a new, effective option to help advance long-term care for patients.”

Stock Performance

Gilead Sciences’ stock dropped down by 1.82%, closing last Friday’s session at $76.42 on volume of 12.92 million shares, which was higher than its 3 month average volume of 9.85 million. The stock has advanced 4.60% in the last month. The company’s shares are trading at a PE ratio of 7.09 and have a dividend yield of 2.46%. The stock currently has a market cap of $101.90 billion.

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