Sanofi Seeks Cure for FDA Concerns at French Factory -- Update

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 [e-mail]

(END) Dow Jones Newswires

February 08, 2017 07:45 ET (12:45 GMT)

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