We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
J&J Files for Single-Tablet Regimen of HIV Drug Prezista in EU
Read MoreHide Full Article
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.
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
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.
JOHNSON & JOHNS Price and Consensus
JOHNSON & JOHNS Price and Consensus | JOHNSON & JOHNS Quote
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.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>