Biotechnology Events

Home

Gilead Sciences, Inc.

.

PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

.

Gilead Announces Full 48-Week Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 15, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed 48-week results from two large Phase 3 clinical trials (Studies 108 and 110) evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection. Data were presented this week during two oral sessions (GS06 and GS12) at The International Liver Congress™ 2016 in Barcelona, Spain.

Both studies met their primary endpoints of non-inferiority to Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300 mg based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. In addition, TAF demonstrated improved renal and bone laboratory safety parameters compared to Viread. Discontinuations due to adverse events were uncommon in both treatment arms. The most commonly reported adverse events in both studies included headache, upper respiratory tract infection, nasopharyngitis and cough, and occurred at similar rates in patients receiving either TAF or Viread. A summary of the topline study results was disclosed in a press release dated January 5, 2016.

“Chronic hepatitis B infection is a life-threatening disease that can lead to liver failure, liver cancer and death,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “With millions of people living with the disease, it remains a significant health concern worldwide. The TAF Phase 3 results presented this week demonstrate its potential to advance the treatment of HBV – offering a similar efficacy profile to Viread with improved bone and renal safety parameters.”

About Studies 108 and 110

Studies 108 and 110, led by Maria Buti, MD, PhD, Liver Unit, Hospital General Universitario Vall d'Hebron, Barcelona, Spain, and Henry L.Y. Chan, MD, Head, Division of Gastroenterology and Hepatology, The Chinese University of Hong Kong, respectively, are randomized, double-blind, 96-week clinical trials among 1,298 treatment-naïve and treatment-experienced patients with chronic HBV infection. In Study 108, 425 HBeAg-negative patients were randomized 2:1 to receive TAF (n=285) or Viread (n=140). In Study 110, 873 HBeAg-positive patients were randomized 2:1 to receive TAF (n=581) or Viread (n=292).

The primary efficacy endpoint of both studies is the proportion of subjects with plasma HBV DNA levels below 29 IU/mL. Key secondary endpoints include change from baseline in bone mineral density at the hip and spine at week 48, and change from baseline in serum creatinine at week 48. Other secondary endpoints include alanine aminotransferases (ALT, an enzyme that serves as a measure of liver damage) normalization and change from baseline in eGFR at week 48.

Based on the results of Studies 108 and 110, Gilead submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for TAF and the FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 11, 2016. Gilead also has submitted regulatory applications for TAF in the European Union and Japan.

TAF as a single-agent for chronic HBV is an investigational product and its safety and efficacy have not been established.
More
Source: press release, 4/15/16. http://www.gilead.com/news/press-releases/2016/4/gilead-announces-full-4...

.

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B
-- High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 12, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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), as well as improvements in surrogate laboratory markers of renal and bone safety as compared to Viread.

“Chronic hepatitis B is a potentially life-threatening disease that impacts millions of people worldwide and often requires prolonged therapy,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Given its lower dose, efficacy and safety profile, TAF has the potential to offer patients an improved treatment option that may advance their long-term care of chronic HBV.”

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 compared to Gilead’s Viread among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. In both studies, changes in renal and bone laboratory safety parameters favored the TAF regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving Viread. Additionally, the overall median 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.

Gilead plans to submit a regulatory application for TAF in the European Union in the first quarter of 2016.

TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established.
More
Source: press release, 1/12/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Tenofovir alafenamide (TAF) (GS-7340) Hep BInfectious DiseaseHepatitis B infection (chronic)nucleotide reverse transcriptase inhibitorReverse transcriptase

Mechanism of action: Tenofovir alafenamide (TAF) (GS-7340), a SM, nucleotide analogue reverse transcriptase inhibitor (nRTI). Tenofovir alafenamide inhibits the transcription of viral RNA into DNA. It is a novel prodrug of tenofovir.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-11-11

Results:

.

U.S. Food and Drug Administration Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
Download PDF Download PDF
-- Vemlidy is a Once-Daily Treatment that Demonstrated Similar Efficacy with Improved Renal and Bone Laboratory Safety Parameters Compared to Viread --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 10, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. See below for important safety information.

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 Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300mg. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.

“Chronic hepatitis B is a life-threatening illness that affects up to 2.2 million people in the U.S.,” said Calvin Pan, MD, Clinical Professor of Medicine, NYU Langone Medical Center, and investigator in the Vemlidy clinical trials. “Clinical trials demonstrated Vemlidy is efficacious with improved renal and bone safety parameters compared to Viread, representing an important development for people living with this chronic disease.”

Photos and multimedia gallery available at www.GileadHBVMedia.com.

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 chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either Vemlidy or Viread, and Study 110 randomized and treated 873 HBeAg-positive patients with either Vemlidy or Viread. Both studies met their primary endpoint of non-inferiority to Viread 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 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.

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

“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.”

Additional data on TAF will be presented at The Liver Meeting® 2016 in Boston.
More
Source: press release, 11/10/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

.