Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Tenofovir Alafenamide (TAF) for Patients with Chronic Hepatitis B Infection

Thursday, March 31, 2016

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for tenofovir alafenamide (TAF) 25 mg, an investigational once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), which is marketed in Japan for the treatment of HBV as Tenozet® by GlaxoSmithKline. TAF has also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to TDF in clinical trials.

“With more than one million people in Japan chronically infected with hepatitis B, there is a significant need for effective new treatment options that offer a favorable safety profile,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President of Research and Development and Chief Scientific Officer. “We are pleased with the results of the Phase 3 studies, which suggest that TAF has the potential to improve the care of chronic hepatitis B patients who require lifelong treatment to manage their disease.”

The NDA for TAF is supported by 48-week data from two Phase 3 studies, which met their primary objective of non-inferiority in efficacy (HBV DNA < 29 IU/mL at Week 48) compared to TDF among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infection. Both studies enrolled patients from a number of clinical sites in Japan. Patients randomized to the TAF arms showed a statistically significant increase in serum alanine aminotransferase normalization relative to the TDF arms when using the American Association for the Study of Liver Disease criteria. Changes in renal and bone laboratory safety parameters favored the TAF treatment arms. Overall, patients receiving TAF experienced a significantly smaller percentage decrease from baseline in hip and spine bone mineral density at Week 48 compared to patients receiving Viread. Additionally, the overall change in serum creatinine from baseline to Week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.

TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established.

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 worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the Japan regulatory authorities may not approve TAF for the treatment of chronic HBV and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize TAF for the treatment of chronic HBV. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statement.

Viread is a registered trademark of Gilead Sciences, Inc., or its related companies.

Tenozet is a registered trademark of GlaxoSmithKline.

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