* Sanofi, Roche await approval for eczema and MS drugs
* GSK faces potential generic competition to Advair
* U.S. FDA due to give verdicts next week
By Ben Hirschler
LONDON, March 23 Three of Europe's top
drugmakers face critical verdicts from U.S. regulators next
week, with Sanofi and Roche likely to win
approvals for two new products, while GlaxoSmithKline
braces for a potential generic rival.
Given earlier impressive clinical trial results, investors
expect the Food and Drug Administration (FDA) to clear both
Roche's multiple sclerosis (MS) treatment Ocrevus and Sanofi's
new eczema drug Dupixent.
The two FDA decisions, due by March 28 and 29 respectively,
mark important landmarks for both firms, since Dupixent and
Ocrevus are expected to be the biggest new drug launches from
the global pharmaceuticals industry in 2017.
Dupixent, developed with Regeneron Pharmaceuticals,
is forecast to sell $4.2 billion annually by 2022, with Ocrevus
seen hitting $4 billion by that time, according to the consensus
of analysts' estimates compiled by Thomson Reuters.
Sanofi's research head says Dupixent marks a new era of
successful innovation for the French company, although the
product is tied up in a patent dispute with Amgen.
The remarkable success of Ocrevus against two types of MS,
meanwhile, will help Roche diversify beyond cancer. The drug has
beaten rivals in fighting relapsing remitting MS and could
become the only approved drug for primary progressive MS.
ADVAIR CHALLENGE FOR GSK
The picture is a lot less certain for Britain's GSK as it
faces the threat of cut-price competition from Mylan,
which hopes to secure approval for the first substitutable
generic copy of GSK's top-selling Advair lung drug by March 28.
Mylan believes it has done everything required to win FDA
approval but its version of Advair would be the first complex
inhaled combination generic product to be approved by the U.S.
agency, so nothing is guaranteed.
That complexity has led some analysts to question whether
Mylan will succeed at its first attempt to gain approval,
potentially delaying the arrival of generics and shielding GSK's
profits from immediate attack.
A second generic version of Advair from Hikma
Pharmaceuticals and Vectura is also awaiting an
FDA approval decision by May 10.
Dealing with the threat of competition to Advair, which has
generated more than $1 billion in annual sales since 2001, is
the first big challenge facing GSK's new chief executive, Emma
Walmsley, who takes over at the end of this month.
GSK has told the market that core earnings per share, in
constant currencies, will be flat to slightly lower in 2017, if
substitutable Advair generics arrive in the United States by
mid-year. If they don't launch, EPS should rise between 5 and 7
(Editing by Greg Mahlich)