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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.

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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF)

– Gilead’s Third TAF-based Filing, Submitted with Priority Review Voucher –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 1, 2015-- 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 an investigational, once-daily single tablet regimen that combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen.

A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act (PDUFA), the anticipated target action date for the R/F/TAF NDA is six months after the FDA’s acceptance of the filing.

“R/F/TAF is Gilead’s third TAF-based filing in less than a year, and we are looking forward to the potential to offer people living with HIV another effective treatment option with a favorable safety profile,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “The R/F/TAF filing also represents Gilead’s next collaboration with Janssen in our combined efforts to increase and potentially improve HIV treatments for a range of patients.”

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 in combination with other antiretroviral agents.

In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review. In November 2014, Gilead filed an NDA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Gilead filed another NDA in April 2015 for two doses of an investigational, fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for use in combination with other HIV antiretroviral agents. Under the PDUFA, the FDA has set a target action date of November 5, 2015, for E/C/F/TAF and April 7, 2016, for F/TAF.

Marketing Authorization Applications in the European Union were fully validated on December 23, 2014, and May 28, 2015, for E/C/F/TAF and F/TAF respectively. Gilead plans to submit a regulatory application for R/F/TAF in the European Union in the third quarter of 2015.

The current NDA is supported by a bioequivalence study demonstrating that R/F/TAF achieved the same drug levels of emtricitabine and TAF in the blood as E/C/F/TAF (10 mg TAF dosage) and the same drug levels of rilpivirine as a 25 mg dose of rilpivirine (Edurant®) alone. The safety and efficacy of TAF is supported by a number of clinical studies in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. In studies, TAF-based treatment (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to TDF-based therapy (administered as E/C/F/TDF or Stribild®).

The R/F/TAF filing is the latest step in an expanded development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, and pending the product’s approval, Gilead will be responsible for the manufacturing, registration, distribution and commercialization of the regimen in most countries, while Janssen will distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States. The original agreement was established for the development and commercialization of Complera®, marketed as Eviplera® in the European Union.

A fourth investigational TAF-based regimen containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir (D/C/F/TAF) also is under development under another licensing agreement. Under the agreement, Gilead is transferring to Janssen further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.

TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
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Source: press release, 7/01/15. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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

Mechanism of action: Rilpivirine (TMC278), is a diarylpyrimidine derivative, an investigatory non-nucleoside reverse transcriptase inhibitor (NNRTI) with a high genetic barrier to the development of resistance. 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). 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.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-03-01

Results:

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U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 InfectionDownload PDF Download PDF
– Odefsey is the Smallest Single Tablet HIV Regimen –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 1, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is Gilead’s second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV.

Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.

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

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

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.

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

The approval is supported by a bioequivalence study demonstrating that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey is supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI- and INSTI-based regimens and virologically suppressed adults with mild-to-moderate renal impairment.

The Odefsey approval is part of an ongoing development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, Gilead is responsible for the manufacturing, registration, distribution and commercialization of the product in most countries, while Janssen will distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States. The original agreement was established for the development and commercialization of Complera®, marketed as Eviplera® in the European Union, and expanded in 2014 to include Odefsey.

Odefsey does not cure HIV infection or AIDS.
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Source: press release, 3/01/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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