HIV specialist ViiV Healthcare, a subsidiary of pharmaceutical maker GlaxoSmithKline (GSK) has announced two potential major breakthroughs in the battle against the virus, highlighting the central role it is likely to occupy in its parent's future.
HIV. Photo: Corona Borealis Studio / Shutterstock
HIV virus cells. Image: Corona Borealis Studio / Shutterstock
ViiV signed a £35 million (€40.5 million) agreement with Japanese pharma firm Shionogi to develop the successor to GSK's blockbuster drug dolutegravir, currently one of the top-selling HIV drugs in the world.
Under the deal, a Shionogi molecule known as S-365592 will be developed as an HIV treatment that can be administered every three months or more, as opposed to the daily cocktail of pills taken by HIV+ people today.
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Shionogi is being paid £20 million for the molecule, with another £15 million being paid when certain milestones are met, as well as royalties on net sales.
Preclinical studies are already underway and human trials are expected to begin in 2023.
In a separate development, the US Food and Drug Administration (FDA) has agreed to fast-track the review process of ViiV's new second-generation HIV jab cabotegravir.
The drug was already approved in Europe and US for the treatment of HIV patients earlier this year, with a decision on whether it can ve used for pre-exposure due in January.
If approved, cabotegravir would be the first, long-acting therapy for the prevention of HIV for those at risk of acquiring the virus.
Human trials have shown it was between three and nine times more effective than current medication on the market.
The double news comes at an opportune time for GSK, with dolutegravir due to come off patent in 2028. In 2020, the HIV drug made up nearly £5 billion (€5.8 billion) of the pharma group's £34 billion (€39.3 billion) total sales and is currently used by around half of the world's 30 million HIV patients.
Demonstrable progress in research for one of the pharma industry's "holy grails" will provide a much-needed boost to GSK CEO Emma Walmsley who is under pressure from investors because of her intention to assume leadership at the group's pharma arm "New GSK" when its consumer healthcare arm is spun off into a new company in 2022.
ViiV CEO Deborah Waterhouse has the spilt will change nothing, saying: "We will continue to develop innovative HIV medicines and perform strongly for our shareholders."
The company offers licences to manufacturers of generic medicines in developing countries to make and distribute the drugs at not-for-profit prices.
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Speaking on the potential of the Shianogi deal, Kimberly Smith, head of R&D at ViiV, said: "Longer and longer regimens - three months or maybe even six months - mean people get to spend less time thinking about their HIV medication and can instead move on to living their best lives.
"Taking a pill every day is a constant reminder of living with HIV which is still a stigmatised disease. We’ve seen the excitement of going from daily to one month, then two months and now we’re looking at every three or four months.
"What we hear from patients is the longer the better," she added.
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