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Glaxo (GSK) Candidate Gets Breakthrough Tag for HIV Prevention

GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare announced that the FDA has granted breakthrough therapy designation to its investigational, long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP), an HIV prevention method.

The prestigious designation was based on data from the phase IIb/III HPTN 083 study, which showed that CAB LA administered every two months is 66% more effective than Gilead’s GILD Truvada daily 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, both populations are at a high risk of HIV infection.

Meanwhile data from phase III HPTN 084, a partner HIV prevention study in sub-Saharan African women, also showed that CAB LA was superior to FTC/TDF.

So far this year, Glaxo’s shares have declined 19% against the industry’s 0.3% increase.



Meanwhile, ViiV Healthcare has also developed a long-acting injectable regimen of cabotegravir and J&J’s JNJ Edurant (rilpivirine) for the treatment of HIV-1 infection in virologically suppressed adults. The regimen will be marketed by the trade name of Cabenuva and is approved in Canada. In the United States, the FDA rejected the long acting cabotegravir + rilpivirine regimen and gave a complete response letter (CRL) in December last year. A regulatory application is under review in the EU.

The regimen 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.

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. While sales of the two-drug regimens are rising, Glaxo is seeing decline in sales of Triumeq and Tivicay due to transition of patients from three-drug regimens to two-drug regimens.

Rising competitive pressure coupled with shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. Sales rose only 1% in the first nine months of 2020.

Glaxo currently has 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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