GlaxoSmithKline strengthens HIV pipeline with new Japanese deal


GlaxoSmithKline PLC (LSE:GSK) underlined its commitment to new vaccines to tackle HIV with subsidiary ViiV Healthcare agreeing to a new deal with Japanese firm Shionogi to develop an ultra-long medicine for the condition.

Shionogi, alongside Pfizer (NYSE:PFE), is a minority shareholder in ViiV and will receive US$20mln upfront, a possible US$15mln in milestone payments and royalties on net sales.

Viiv has already worked with Shionogi to produce Dolutegravir and cabotegravir, arguably two of the most important HIV medicines of the last decade said Kimberly Smith, Viiv’s head of R&D.

“Dolutegravir is now taken by 17 million people globally, and cabotegravir has allowed us to develop the first long-acting regimen for treatment.”

However, Glaxo loses dolutegravir exclusivity in 2028 and there have been concerns over how Glaxo will replace it, but Smith said: “With today’s announcement about the in-licensing of a third integrase inhibitor from Shionogi, we will continue this collaboration and explore the potential of S-365598 to anchor ViiV Healthcare’s pipeline beyond 2030.”

Preclinical studies are underway, said the statement, with preliminary data indicating the treatment,has a high genetic barrier and a resistance profile that is distinct from that of dolutegravir and cabotegravir.

“Its long half-life may support its development as an ultra-long medicine that could be delivered with infrequent dosing of every three months or longer.”

In human studies are expected to start in 2023.

Separately, Glaxo also said US regulator the FDA had granted a priority review to ViiV’s application for cabotegravir long-acting to prevent HIV.

If approved, cabotegravir would be the first, long-acting therapy for the prevention of HIV for individuals at risk of sexually acquired HIV-1 infection, who have a negative HIV-1 test prior to initiation, ViiV said.

Smith added: “The FDA’s Priority Review designation of cabotegravir long-acting for PrEP (pre-exposure prophylaxis) underscores the importance of this medicine, supported by the results of the HPTN studies, which demonstrated cabotegravir’s superior efficacy over daily oral FTC/TDF tablets.

“In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options.”

Glaxo and its boss Emma Walmsley have been under fire from activist investor Elliot Management over its sluggish share price performance and how its pipeline of new drugs compares to rivals such as AstraZeneca.

GSK shares rose 0.4% to 1,392p.


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