* GSK talking to regulators about potential approval
* Injection 69% more effective than daily Truvada pill
* GSK likely to face market flooded by cheap Truvada copies
(Adds quote from ViiV executive, shares, analyst comment)
By Ludwig Burger
May 18 (Reuters) - GlaxoSmithKline said an injection
every other month of its cabotegravir drug was shown to avert an
HIV infection more effectively than Gilead's daily
Truvada pill, potentially giving its ViiV unit a foothold in HIV
prevention.
The drug trial involving men who have sex with men was
stopped early by an independent monitoring board after
cabotegravir was found to be 69% more effective than the current
standard of care, Truvada, the British drugmaker said on Monday.
But the market segment GSK is eyeing is about to become more
competitive as cheaper generic versions of Truvada are expected
to be launched in the United States in September, as the patent
expires.
Gilead, for its part, hopes that Truvada users will opt
against the cheaper copies and switch to its new daily pill
Descovy, approved in October 2019 after it was shown to be less
toxic to the kidneys and bones.
Truvada generated $2.8 billion in sales last year, both from
treatment and preventing an HIV infection.
Kimberly Smith, ViiV's head of research, said a long-acting
injection was a better route of administer because users have
shown to struggle with a strict routine of daily pills,
heightening the infection risk.
"Individuals have to show up every eight weeks in the clinic
for the injection but in-between there is not a need to take a
pill daily, so you really change the equation for adherence with
a long acting (drug)," Smith said.
GSK, which is trailing Gilead in the HIV treatment market,
will speak to drug regulators about a possible approval of
cabotegravir based on the prevention trial, a spokesman said.
Its shares were up 1.25% at 1120 GMT, outperforming a 0.8%
gain in the STOXX Europe 600 Health Care
Prevention "has turned into a multi-billion opportunity for
Gilead but we think consensus estimates include little or
nothing for GSK in this market," UBS analysts said in a research
note.
GSK has won approval in Canada for cabotegravir as one of
two key ingredients in long-acting HIV treatment combination
Cabenuva, whereas in the United States, the company has run into
delays seeking the go-ahead for Cabenuva.
An initial readout from the trial, which started in late
2016, was previously not expected before next year.
A similar trial to test the cabotegravir injection to
prevent HIV in women, is still ongoing.
Pfizer and Shionogi & Co Ltd hold small
stakes in GSK's HIV-focused ViiV Healthcare division.
(Reporting by Ludwig Burger, editing by Louise Heavens)
Glaxosmithkline (GSK)
