Glaxo Begins Phase III Study On Injection To Prevent HIV

GlaxoSmithKline plc (NYSE:GSK) has announced the start of a large late-stage African study on an experimental long-acting injection for the prevention of HIV. ViiV Healthcare, an HIV company majorly owned by Glaxo and Pfizer (NYSE:PFE) , said that the phase III study, HPTN 084, will evaluate long-acting cabotegravir monotherapy for the prevention of HIV infection in sexually active women.

ViiV Healthcare is conducting the study under a public private funding collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Bill & Melinda Gates Foundation. While NIAID, part of the National Institutes of Health (NIH), is sponsoring the study, ViiV Healthcare and Gilead (NASDAQ:GILD) are providing the medicines. The study will enrol more than 3,000 women between the age of 18 and 45 from sub-Saharan African countries.

In order to prevent HIV infection, uninfected people, at present, use oral anti-retroviral medication, which needs to be taken every day. Compared to these, cabotegravir injections will be administered every two months, if approved

Glaxo’s shares have declined 9% this year so far, underperforming the 16.2% increase witnessed by the industry.

ViiV Healthcare is already conducting a HPTN 083 study on cabotegravir in HIV-uninfected men and transgender women who have sex with men, also under co-funding with NIAID. Meanwhile, cabotegravir is also being evaluated in three late stage studies as a two drug regimen with Johnson & Johnson’s (NYSE:JNJ) Edurant/rilpivirine, with the third study initiation announced earlier this week.

Last week Glaxo and partner J&J announced FDA approval of the first dual treatment for HIV, Juluca (Tivicay/dolutegravir + Edurant/rilpivirine). Juluca has been developed under a partnership between ViiV Healthcare and Janssen.

HIV has been a key therapeutic area for Glaxo. Its two new HIV drugs, Tivicay and Triumeq have been recording consistently strong sales while gaining market share. Glaxo’s HIV sales rose 16% at constant exchange rate in the first nine months of 2017. Meanwhile, a significant portion of its R&D expenditures goes toward developing HIV medicines to treat/prevent HIV.

Glaxohas a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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