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J&J Files for Single-Tablet Regimen of HIV Drug Prezista in EU
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Johnson & Johnson (JNJ - Free Report) subsidiary, Janssen Therapeutics announced that it has submitted a marketing authorization to the European Medicines Agency for a once-daily single tablet regimen (STR) containing its HIV drug Prezista.
The company is seeking approval of the STR containing Prezista and Gilead, Inc.'s (GILD - Free Report) Tybost, emtricitabine (trade name Emtriva) and tenofovir alafenamide in the EU for the treatment of HIV -1 in adults and adolescents (aged 12 years and older with body weight of at least 40 kg). Gilead and Janssen have formed a licensing agreement in 2014 for the development and commercialization of the STR. Janssen is responsible for the manufacture, registration, distribution and commercialization of the product worldwide.
A fixed-dose combination of Prezista with Tybost – Prezcobix – is already approved for use in combination with other antiretroviral agents for treatment-naïve and treatment-experienced HIV-1 adults with no Prezista resistance-associated substitutions.
A once-daily STR – Odefsey containing Gilead’s Emtriva (200 mg) and tenofovir alafenamide (25 mg) and Johnson & Johnson’s Edurant (25 mg) – has gained approval in the EU and the U.S. this year for the treatment of HIV-1 infection.
While Gilead is responsible for the manufacturing, registration, distribution and commercialization of Odefsey in most countries, Janssen will distribute it in about 18 markets and have co-detailing rights in several key markets including the U.S. The original agreement was signed for the development and commercialization of Complera/Eviplera and was expanded in 2014 to include Odefsey.
According to information provided in the press release, almost 70 million people worldwide are infected with the HIV virus. HIV is a one of the primary areas of focus for Giliead.
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J&J Files for Single-Tablet Regimen of HIV Drug Prezista in EU
Johnson & Johnson (JNJ - Free Report) subsidiary, Janssen Therapeutics announced that it has submitted a marketing authorization to the European Medicines Agency for a once-daily single tablet regimen (STR) containing its HIV drug Prezista.
The company is seeking approval of the STR containing Prezista and Gilead, Inc.'s (GILD - Free Report) Tybost, emtricitabine (trade name Emtriva) and tenofovir alafenamide in the EU for the treatment of HIV -1 in adults and adolescents (aged 12 years and older with body weight of at least 40 kg). Gilead and Janssen have formed a licensing agreement in 2014 for the development and commercialization of the STR. Janssen is responsible for the manufacture, registration, distribution and commercialization of the product worldwide.
A fixed-dose combination of Prezista with Tybost – Prezcobix – is already approved for use in combination with other antiretroviral agents for treatment-naïve and treatment-experienced HIV-1 adults with no Prezista resistance-associated substitutions.
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A once-daily STR – Odefsey containing Gilead’s Emtriva (200 mg) and tenofovir alafenamide (25 mg) and Johnson & Johnson’s Edurant (25 mg) – has gained approval in the EU and the U.S. this year for the treatment of HIV-1 infection.
While Gilead is responsible for the manufacturing, registration, distribution and commercialization of Odefsey in most countries, Janssen will distribute it in about 18 markets and have co-detailing rights in several key markets including the U.S. The original agreement was signed for the development and commercialization of Complera/Eviplera and was expanded in 2014 to include Odefsey.
According to information provided in the press release, almost 70 million people worldwide are infected with the HIV virus. HIV is a one of the primary areas of focus for Giliead.
J&J carries a Zacks Rank #2 (Buy). Other stocks worth considering in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) and Geron Corporation (GERN - Free Report) . Both the companies enjoy a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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