Biotechnology Events

Home

Gilead Sciences, Inc.

.

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

.

John F. Milligan, PhD, President and COO, commented on the regulatory outlook for several programs. He stated, "Two other TAF-based regimens are pending regulatory approval in the U.S. and EU. F/TAF has been assigned a PDUFA date of April 7, and in the EU a CHMP opinion could be adopted in the first quarter of this year. R/F/TAF has been assigned a PDUFA date of March 1, and a CHMP opinion is expected in the second half of this year. This means that Gilead could launch two new TAF-containing products in the coming months, giving patients a wider range of options for the treatment of their HIV."
Source: Q4 2015 earnings conference call, 2/02/16.

.

European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment
– If Approved, Would Provide Potential New Backbone for Future HIV Therapy Combinations –

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 28, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company’s Marketing Authorization Application (MAA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). The data included in the application support the use of F/TAF for the treatment of HIV-1 infection in adults in combination with other HIV antiretroviral agents.

TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.

“Therapy innovations have transformed HIV into a chronic condition and people with HIV are living longer, necessitating new treatment options that deliver on both high efficacy and long-term safety,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “F/TAF is the latest advance in Gilead’s long history of innovating in HIV therapy and has the potential to become the backbone for the next generation of HIV regimens.”

F/TAF is Gilead’s second F/TAF-based regimen to be validated by the EMA. An MAA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) was fully validated on December 23, 2014. In addition, Gilead filed New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF and F/TAF on November 5, 2014, and April 7, 2015, respectively.

The MAA for F/TAF is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The MAA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.

Review of the MAA will be conducted by the EMA under the centralized procedure, which, when finalized, may lead to the grant of marketing authorization by the European Commission, which is valid in all 28 member states of the European Union.

F/TAF and TAF are investigational products and have not been determined to be safe or efficacious.
More
Source: press release, 5/28/15. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Emtricitabine/TAF combination (F/TAF)Infectious DiseaseHuman Immunodeficiency Virus (HIV)Combination therapy (antiretroviral)Various HIV

Mechanism of action: Tenofovir alafenamide (TAF) (GS-7340) is a SM, nucleotide analogue reverse transcriptase inhibitor (nRTI). It inhibits the transcription of viral RNA into DNA and is a novel prodrug of tenofovir. Emtricitabine (FTC) is a small molecules that inhibit the transcription of viral RNA into DNA by acting as a nucleotide analogue reverse transcriptase inhibitor (nRTI).

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-02-26

Results:

.

European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV

PDF Download
– Descovy is the First New HIV Treatment Backbone Approved in the EU in Over a Decade –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 25, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. Descovy is Gilead’s second TAF-based therapy to receive marketing authorization in the European Union.

Descovy is indicated in the European Union for the treatment of adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents. The marketing authorization is based on a Phase 3 HIV clinical program evaluating F/TAF in combination with other antiretroviral agents in treatment naïve, virologically suppressed, renally impaired and adolescent patients. The marketing authorization allows for the marketing of Descovy in all 28 countries of the European Union.

“Treatment backbones, paired with a third agent, are a cornerstone for successful management of HIV. Descovy is the first new HIV backbone approved in Europe in more than a decade and represents an important advance in addressing the needs of patients,” said Dr. José Arribas, Associate Professor of Medicine, Autonoma University School of Medicine, Madrid. “The components of Descovy, either as part of a single or multi tablet regimen, offer physicians and their patients a simple and effective combination with improvements in renal and bone lab safety parameters.”

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). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.

“TAF represents the latest development in Gilead’s more than 25-year history of innovation in the field of HIV, and we are pleased to offer patients and physicians another TAF-based therapy that expands their treatment options,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We look forward to making Descovy available as quickly as possible throughout the European Union as we continue to advance a pipeline of HIV regimens that contain TAF.”

The marketing authorization for Descovy is supported by 48-week data from a Phase 3 study (Study 1089) evaluating the safety and efficacy of switching virologically suppressed HIV-1 infected adult patients from regimens containing emtricitabine and tenofovir disoproxil fumarate (F/TDF; Truvada®) plus a third agent to regimens containing F/TAF plus the same third agent. At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies per mL. The study also demonstrated statistically significant improvements in renal and bone laboratory parameters among patients receiving the F/TAF-based regimens.

The marketing authorization is also supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) evaluating an F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg; E/C/F/TAF) against an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg; E/C/F/TDF) among treatment naïve adult patients. In these studies, certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen. Additionally, the marketing authorization is supported by data from studies evaluating an F/TAF-based regimen (administered as Genvoya) among adults with mild-to-moderate renal impairment and among treatment naïve adolescents. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of Descovy achieved the same drug levels of TAF and emtricitabine in the blood as in Genvoya.
More
Source: press release, 4/25/16. http://www.gilead.com/news/press-releases/2016/4/european-commission-gra...

.

European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 26, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents.

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). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.

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.

The MAA for Descovy is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. In the studies, the F/TAF-based regimen demonstrated statistically significant improvements in surrogate laboratory markers of renal and bone safety as compared to the F/TDF-based regimen. The MAA is also supported by data from an additional Phase 3 study evaluating Descovy among virologically suppressed adults who switched regimens (Study 1089), and studies evaluating the F/TAF-based regimen (administered as Genvoya) among adults with mild-to-moderate renal impairment and among adolescents. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of Descovy achieved the same drug levels of TAF and emtricitabine in the blood as in Genvoya.

Descovy is an investigational product and its efficacy and safety have yet not been established in the European Union.
more
Source: press release, 2/26/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

.