GlaxoSmithKline (GSK) is making bold predictions for its HIV business, driven by the remarkable success of its long-acting antiretroviral therapy Cabenuva. The company is now projecting sales growth of 6% to 8% for its HIV segment, targeting a figure of £7 billion ($8.5 billion) by 2026, a significant leap from its previous “mid-single-digit” growth expectations.
Notably, analysts at ODDO BHF had already raised the valuation for GSK’s HIV business by a similar margin in late 2022, with estimates suggesting Cabenuva alone could achieve £3 billion in sales by 2030.
To put this into perspective, GSK’s HIV drug sales in 2022 totaled £5.7 billion, marking a substantial 12% increase over 2021 at constant exchange rates. Deborah Waterhouse, CEO of GSK’s specialized HIV subsidiary ViiV Healthcare, emphasized that Cabenuva’s strong performance was a key driver behind the heightened projection.
This long-acting regimen is anticipated to constitute one-third of GSK’s HIV revenue by 2026. Additionally, the company noted growing acceptance of its Apretude injection for HIV prevention among at-risk populations, along with increasing demand for its shingles vaccine.
Waterhouse highlighted that the strong performance of newer-generation drugs like Cabenuva will help offset the patent expirations of older-generation medications. Dolutegravir, one such older drug, is set to lose patent protection by the end of the decade. The core composition patent for dolutegravir expires in 2028, while the formulation patents for Dovato and Juluca expire in 2029 and 2030, respectively.
A significant part of this growth projection can be attributed to the rising demand for long-acting HIV regimens. Traditional daily oral doses leave little room for error, as missing even a single day can have significant consequences for patients. Long-acting regimens offer patients more flexibility and peace of mind.
Cabenuva, first approved by the FDA in January 2021, brought a revolutionary change to HIV-1 treatment. Instead of daily antiviral pills, patients only needed injections once a month or 12 times a year. In February 2022, the FDA granted approval for Cabenuva’s use every two months, halving the dosing frequency.
However, Waterhouse acknowledged the burden of patients having to visit clinics six times a year for injections. This is why GSK is actively developing ultra-long-acting drugs and self-administered treatments.
GSK is striving to select a long-acting, self-administered drug candidate by next year, aiming for approval by 2030. The company is also exploring the potential of cabotegravir, a component of Cabenuva, to be formulated into a twice-yearly treatment by 2030.
While GSK is making significant strides, daily pills like Gilead Sciences’ Biktarvy remain the standard in HIV treatment. Gilead is also working on a long-acting injectable HIV treatment, lenacapavir, which can be administered every six months. In July 2023, Gilead reported positive data from the Phase II/III CAPELLA trial for lenacapavir.
In a groundbreaking development in August 2022, Gilead secured regulatory approval for twice-yearly treatment with lenacapavir, marking a significant milestone for adults living with multi-drug resistant HIV, as granted by the European Commission.