GlaxoSmithKline strengthens pipeline with hopes for two future HIV blockbusters

·3-min read
 (Viiv Healthcare)
(Viiv Healthcare)

Drugs maker GlaxoSmithKline’s subsidiary ViiV Healthcare today announced two potential breakthroughs in its pipeline, underlying the central role the HIV specialist expects to play in its parent’s future.

Viiv CEO Deborah Waterhouse (Viiv Healthcare)
Viiv CEO Deborah Waterhouse (Viiv Healthcare)

ViiV has signed a £35 million deal with Japan’s Shionogi to develop a possible successor to Glaxo’s blockbuster medicine dolutegravir, one of the world’s top-selling HIV drugs.

Initial data suggests that the compound — a virus-blocker known only as S-365598 — is longer-lasting than its predecessors, meaning patients might only need one jab every three months rather than taking a daily cocktail of pills.

Preclinical studies are under way with human trials expected by 2023.

Separately, the US Food and Drug Administration has placed ViiV’s new second-generation HIV shot cabotegravir onto a fast-track review to assess its potential to prevent people from acquiring the infection.

The drug was approved for use in the treatment of HIV patients in Europe and the US at the turn of the year.

A decision on whether it can be also used pre-exposure is due in January.

Human trials showed it was between three and nine times more effective than existing therapies.

The two developments come at a critical time for Glaxo, with dolutegravir — which accounted for almost £5 billion of the group’s £34 billion total sales in 2020 — coming off patent in 2028. It is used by more than half of the 30 million HIV patients globally.

Kimberly Smith, Viiv head of R&D (Viiv)
Kimberly Smith, Viiv head of R&D (Viiv)

Solid progress in research will also bolster group CEO Emma Walmsley, who faces pressure from activist investors over her intention to assume the leadership role at Glaxo’s pharma division “New GSK” when its consumer healthcare arm is carved off into a separate company next year.

Deborah Waterhouse, ViiV CEO, said that “nothing will change” for the venture post-split, adding: “We will continue to develop innovative HIV medicines and perform strongly for our shareholders.”

Glaxo offers licences to generics manufacturers to make and distribute treatments at not-for-profit price in developing countries.

Kimberly Smith, Viiv’s head of R&D, said of the Shianogi tie-up’s potential: “Longer and longer regimens - three months or maybe even 6 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 3 or 4 months.

“What we hear from patients is the longer the better.”

She said approval for cabotegravir’s use as a preventative medicine would also be game-changing: “If we are really going to get to the end of the HIV epidemic, part of that road map has to include more effective prevention.

“In sub-Saharan Africa the number of young women becoming infected is astronomical, as many as 10% to 12% of young women are becoming HIV infected each year.

“Condoms have been there for a long time but despite that people are continuing to get infected in very large numbers. We need something beyond that and this is that next step.”

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