GlaxoSmithKline GSK along with partner Pfizer, Inc. PFE announced that their HIV-focused joint venture company, ViiV Healthcare, has initiated a phase III program to evaluate its two-drug HIV regimen of dolutegravir (Tivicay) and lamivudine (Epivir) The study will evaluate the two-drug regimen for maintenance of viral suppression achieved in HIV-1 infected patients on a three-drug regimen - tenofovir alafenamide fumarate ("TAF")-based regimen.
We remind investors that Glaxo is also evaluating another two-drug based regimen - cabotegravir and Johnson & Johnson's JNJ rilpivirine - in another phase III study for treating adults with virally suppressed HIV-1 infection. Moreover, the company is also evaluating cabotegravir monotherapy for the prevention of HIV infection in sexually active women.
HIV treatments generally are three-drug based regimens. The latest entrant in the market is Gilead Sciences, Inc.'s GILD once-daily single tablet regimen, Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide), approved earlier this month. However, Glaxo is trying to reduce the number of medicines in a HIC treatment regimen without compromising on the efficacy of a conventional three-drug regimen
Shares of GlaxoSmithKline have underperformed the industry so far this year. The stock has lost 9.6% against the industry's 10.1% rally during the period.
The phase III TANGO study will investigate a two-drug regimen for the treatment of HIV. The phase III program is designed to evaluate non-inferior antiviral activity of the combination regimen at 48 weeks compared to continuation of a TAF-based regimen. The study will also evaluate long-term antiviral activity, tolerability and safety of the combination therapy for up to 96 weeks.
Glaxo is also evaluating the combination regimen in GEMINI studies in patients with HIV-1 who have received no prior treatment. Data from the GEMINI and TANGO studies are anticipated in 2018.
We note that Glaxo's newest HIV medicine - Juluca is a single tablet containing dolutegravir and J&J's rilpivirine. Juluca is the first two-drug regimen approved by the FDA.
Meanwhile, with several companies interested in developing drugs to treat this life-threatening disease, competition has intensified manifold in the space.
GlaxoSmithKline PLC Price
GlaxoSmithKline PLC Price | GlaxoSmithKline PLC Quote
GlaxoSmithKline carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer, Inc. (PFE): Free Stock Analysis Report Johnson & Johnson (JNJ): Free Stock Analysis Report GlaxoSmithKline PLC (GSK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research