GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare announced interim data from the phase IIb/III (HPTN 083) study, which showed that its investigational, long-acting injectable cabotegravir (CAB LA) administered every eight weeks was highly effective at preventing HIV compared to the currently available oral tablets for daily use.
The data showed that CAB LA is 69% more effective than current standard of care, Gilead’s GILD Truvada daily oral pills (emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF)) in preventing HIV acquisition in the study population. The study population included men who have sex with men (MSM) and transgender women who have sex with men
The large HPTN 083 study is being conducted in approximately 4,600 HIV patients across North and South America, Asia, and Africa. The study is jointly sponsored by U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and ViiV Healthcare
The interim analysis was conducted by the independent Data and Safety Monitoring Board (DSMB) which recommended that the study be stopped early as the data clearly showed that CAB LA was highly effective in preventing HIV in the study population. The participants who were receiving Truvada will now be offered CAB LA. Truvada generated sales of $2.8 billion for Gilead in 2019. However, generic versions of Truvada are expected to be available from September this year.
Please note that cabotegravir has not yet been approved for the treatment or prevention of HIV as a monotherapy. However, as a combination regimen with J&J’s JNJ Edurant (rilpivirine), long-acting cabotegravir was approved in March in Canada for the treatment of HIV-1 infection in virologically suppressed HIV adults. The regimen will be marketed by the trade name of Cabenuva.
The long-acting regimen of cabotegravir plus Edurant has been co-developed as part of a collaboration between Janssen and ViiV Healthcare. It reduces the dosing schedule in virologically suppressed HIV patients from 365 days to 12 days per year while maintaining their viral suppression. The approval of Cabenuva was based on data from the pivotal phase III ATLAS and FLAIR studies.
So far this year, Glaxo’s shares have declined 12.1% compared with the industry’s 1% decline.
In the United States, the FDA rejected Glaxo’s new drug application (NDA) seeking approval of the long-acting HIV regimen and gave a complete response letter (CRL) in December last year. Glaxo, back then, had said the CRL was related to chemistry, manufacturing and controls (CMC) and there were no reported safety issues related to CMC. ViiV Healthcare had filed the NDA for the long-acting regimen in April, which was granted priority review by the FDA in July. A regulatory application is under review in the EU.
Please note that Pfizer PFE and Shionogi Limited own stakes in ViiV Healthcare.
HIV is a key therapeutic area for Glaxo with dolutegravir-based regimens in its portfolio. The dolutegravir franchise comprises two three-drug regimens, namely Triumeq and Tivicay and two two-drug regimens, Juluca and Dovato. Dovato was launched in the United States and Europe in 2019. Sales of Glaxo’s HIV business rose 8% in the first quarter of 2020
Glaxo currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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