GlaxoSmithKline has put long-acting injectables at the heart of plans to grow its HIV business. GSK is looking to transition to a portfolio built around cabotegravir to mitigate the loss of patent protection on dolutegravir and hold off a challenge from Gilead and Merck.
Facing pressure to transform the business, GSK CEO Emma Walmsley has made (PDF) HIV one of four key therapeutic areas and put long-acting injectable drug delivery technologies at the center of her plans for the business unit. The idea is to build on the recent approval of the cabotegravir-based Cabenuva to grow the market for long-acting injectable HIV treatments to up to £5 billion ($7 billion) by 2030.
GSK expects cabotegravir-based regimens to account for more than one-third of its portfolio by 2026, two to three years before the dolutegravir patent expirations. From 2026 onward, GSK is tipping its early-stage pipeline to drive growth as it works to convert 90% of its business to long-acting regimens by 2031. GSK thinks it has at least a five-year head start in the competition in the space.
There is some skepticism about whether GSK’s bet will pay off. In a Q&A after the presentation of GSK’s plans, Tim Anderson, an analyst at Wolfe Research, questioned (PDF) how well an injectable-focused strategy will fare in a future in which Gilead and Merck have a rival once-weekly oral drug. Kimberly Smith, head of global research and medical strategy at GSK’s ViiV, gave a bullish response.
“We are not the least bit intimidated by the idea of oral versus injectable,” Smith said. “We know patients want to be able to decrease the impact of HIV treatment on their lives, and that means minimizing the frequency of dosing, and that is what we are trying to do with our ultra-long-acting options.”
GSK gained access to ultra-long-acting technology through its recent deal with Halozyme. Prior to inking the deal, GSK began development of a cabotegravir formulation dubbed CAB 400. The drug is designed to give a bigger dose with a smaller volume. Phase 1 data are due next year. The Halozyme deal is intended to enable GSK to give still-larger doses subcutaneously.