Sanofi Seeks Cure for FDA Concerns at French Factory -- Update
February 08 2017 - 08:00AM
Dow Jones News
By Noemie Bisserbe
PARIS--Drugmaker Sanofi SA has addressed all the manufacturing
deficiencies at the French plant where its new, promising
rheumatoid arthritis treatment will be produced, Chief Executive
Olivier Brandicourt said Wednesday.
In October, the U.S. Food and Drug Administration had rejected
sarilumab, a treatment being developed jointly by Sanofi and
Regeneron Pharmaceuticals Inc., over deficiencies found at the
plant.
Sanofi shares were trading up 2.2% at EUR77.53 in midday
trading.
"We worked closely with the U.S. FDA to implement a corrective
plan and got positive feedback," Mr. Brandicourt said.
He expects health regulators to conduct a formal inspection at
the plant in the first quarter of the year and hopes to be able to
launch sarilumab a few months later.
The plant in Normandy, North of France, will also manufacture
Dupilumab, a new treatment for severe forms of eczema that is
slated for U.S. regulatory approval this year.
Sanofi, which missed out on two major takeover deals in recent
months, is under pressure to launch new drugs as some its
blockbuster drugs go off patent.
It lost out to Pfizer Inc. in a bidding war for cancer drugmaker
Medivation in August. Late last year, talks with Actelion Ltd.
collapsed after the French major and the Swiss biotech failed to
hash out an agreement. Johnson & Johnson agreed to take over
Actelion for $30 billion in January.
Sanofi warned Wednesday its earnings may fall in 2017, as its
best-selling drug, Lantus insulin, faces increasing competition
from generic drugs in the U.S.
The Paris-based drugmaker said it expects business earnings per
share--excluding the impact of acquisitions and divestments--to be
stable or decline by up to 3% in 2017 at constant exchange
rates.
In the fourth quarter, business net income, the company's term
for adjusted income excluding the impact of acquisitions and
divestments, declined 6% to EUR1.61 billion hit by higher taxes.
That, however, beat analysts' expectations of EUR1.59 billion,
according to a poll by data provider FactSet. Revenue rose 3% to
EUR8.87 billion, boosted by biotech sales.
Genzyme, Sanofi's biotech unit, posted a 14% jump in revenue to
EUR1.34 billion, while vaccine sales rose 4% to EUR1.35
billion.
Diabetes drug sales, which account for about 20% of the
company's revenue, rose 3% to EUR1.58 billion in the
fourth-quarter.
Sanofi said Wednesday it will pay shareholders a dividend of
EUR2.96 a share for 2016.
Write to Noemie Bisserbe at noemie.bisserbe@wsj.com
(END) Dow Jones Newswires
February 08, 2017 07:45 ET (12:45 GMT)
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