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Gilead Sciences, Inc.

Partner : Janssen R&D Ireland Limited

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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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European Medicines Agency Validates Gilead’s Marketing Application for Single Tablet Regimen Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) for HIV Treatment

– Gilead’s Third TAF-based Filing Under Review by EMA –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 20, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the company’s Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older.

“With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV.”

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 MAAs for TAF-based regimens are under review by the EMA. The 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. The MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) was fully validated on May 28, 2015. Gilead has submitted New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF, F/TAF and R/F/TAF on November 5, 2014, April 7, 2015, and July 1, 2015, respectively.

The current MAA is supported by a bioequivalence study demonstrating that administration of R/F/TAF results in the same blood levels of emtricitabine and TAF as those that are achieved with E/C/F/TAF (10 mg TAF dosage) and the same 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 will be reviewed by the EMA under the centralized procedure, which, when finalized, may lead to the granting of marketing authorization by the European Commission, which is valid in all 28 member states of the European Union.

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. The original agreement was established for the development and commercialization of Eviplera®, marketed as Complera® in the United States.

A fourth investigational TAF-based regimen containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir (D/C/F/TAF) is also under development under a separate 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 and TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
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Source: press release, 8/20/15. 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 EMA: CHMP Opinion (Estimate)

Dates: 2016-07-22

Results:

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European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV

– Odefsey is the Second Single Tablet Regimen Containing the Descovy Backbone and the Third Product in Gilead’s New TAF Portfolio to be Approved in Europe –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 23, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen (STR) 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. Odefsey combines Gilead’s emtricitabine and tenofovir alafenamide (marketed as Descovy®) with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Following the approval of Genvoya in November 2015, Odefsey is Gilead’s second STR based on the Descovy backbone to receive marketing authorization in the European Union and is currently the smallest pill of any STR for the treatment of HIV.

Odefsey 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) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load less than 100,000 HIV-1 RNA copies/ml.

“People living with HIV today are increasingly likely to be receiving treatment for other conditions – such as heart and liver disease – because they are living longer than ever before, exposing them for longer periods of time to the virus and to the medications used to treat it. Therefore, we need new treatment options that are not only efficacious but also tolerable, and with convenient dosing,” said Andy Ustianowski, MD, North Manchester General Hospital. “Odefsey combines the antiviral efficacy and safety profile of the new Descovy backbone with the established tolerability profile of rilpivirine as a third agent.”

Photos and multimedia gallery available at www.GileadHIVEU.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.

“The approval of Odefsey underscores Gilead’s ongoing commitment to researching and developing new treatment options to help address the evolving needs of a range of HIV patients,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “Through our new portfolio of products based on the Descovy backbone, Gilead is pleased to offer effective treatments and simple dosing options for people living with HIV, which has now become a chronic condition for most patients.”

The marketing authorization for Odefsey 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; E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey are also supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or Eviplera®; emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 245 mg) and F/TAF-based therapy (administered as Genvoya) in a range of patients with HIV-1 infection. These patients include treatment-naïve adults and adolescents, virologically suppressed adults who switched from protease inhibitor-based regimens, NNRTI-based regimens, or integrase strand transfer inhibitor-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment. As with all rilpivirine-containing regimens, Odefsey should be taken with food.

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 Odefsey in most countries, while Janssen will distribute it in approximately 18 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 Eviplera, marketed as Complera® in the United States, and was expanded in 2014 to include Odefsey.

For important safety information for Odefsey including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Odefsey available from the EMA website at www.ema.europa.eu.
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Source: press release, 6/23/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 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 Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg; R/F/TAF), an investigational single tablet regimen for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) without known mutations associated with resistance to the NNRTI class, tenofovir or emtricitabine, and with a viral load less than 100,000 copies per mL. Odefsey combines Gilead’s emtricitabine and tenofovir alafenamide with rilpivirine, owned by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and marketed by Janssen Cilag International NV.

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 Odefsey 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; E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey are supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or Eviplera®; R/F/TDF) and F/TAF-based therapy (administered as Genvoya) in a range of patients with HIV-1 infection. These patients include treatment-naïve adults and adolescents, virologically suppressed adults who switched from protease inhibitor-based regimens, non-nucleoside reverse-transcriptase inhibitor-based regimens, or integrase strand transfer inhibitor-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment.

The Odefsey CHMP opinion is part of an ongoing 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 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 Eviplera, marketed as Complera® in the United States, and was expanded in 2014 to include Odefsey.

In the European Union, Odefsey is an investigational product and its efficacy and safety have yet not been established.
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Source: press release, 4/29/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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