GSK
files potential $1 billion shingles vaccine for U.S.
approval
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[October 24, 2016]
By Ben Hirschler
LONDON (Reuters) - GlaxoSmithKline has
filed its shingles vaccine Shingrix for U.S. regulatory approval, the
drugmaker said on Monday, bringing the potential $1 billion-a-year
seller a step closer to market.
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Shingrix is viewed by analysts as among the British company's most
promising experimental products, since it has shown greater
protection among older recipients than Merck & Co's rival shot
Zostavax.
GSK itself highlighted Shingrix as one of its top near-term pipeline
hopes last November, during its first research and development day
in more than a decade.
The company, which will see Emma Walmsley take over as chief
executive in 2017, is seeking to revitalise a drug portfolio hit by
falling sales of best-selling inhaled lung treatment Advair.
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In clinical trials, GSK's vaccine remained 90 percent effective in
people over age 70, even four years after injections. Zostavax
efficacy, by contrast, varies between 18 and 70 percent, and it
declines noticeably in older people.
People who are 70 years or older are often most at risk from
shingles, a painful, itchy rash that results from the reactivation
of latent chickenpox virus.
The impressive trial results should put Shingrix in a strong
competitive position, analysts believe, even though it requires two
doses, against just one for Zostavax, and it is also linked to more
injection site reactions.
Analysts, on average, predict that worldwide sales of Shingrix will
reach 856 million pounds ($1.05 billion) in 2021, according to
consensus forecasts compiled by Thomson Reuters.
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Sales of Zostavax, the only shingles vaccine on the market at
present, totalled $749 million in 2015.
GSK's vaccine contains a component from U.S. biotech firm Agenus,
which is entitled to royalties on future sales.
GSK said it planned to file Shingrix for European and Canadian
approval before the end of this year, with Japan following in 2017.
($1 = 0.8191 pounds)
(Editing by Susan Fenton and Jason Neely)
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