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 Toujeo is a more potent follow-up to the French drugmaker's
top-selling Lantus insulin product, which accounts for a fifth of
group sales and is due to go off U.S. patent this year.
The Food and Drug Administration on Wednesday approved the new
once-daily, long-acting basal insulin to treat adults with both type
1 and the far more prevalent type 2 diabetes.
Analysts noted, though, that some potential benefits were not
mentioned on the FDA-approved label, which also highlighted the need
for higher doses to achieve the same level of glycemic control.
"The Toujeo label is probably going to be viewed as more
undifferentiated than investors have been expecting," Bernstein
analysts, who rate the stock "outperform", said in a research note.
Citi analysts called the label "not great".
Sanofi shares were 1 percent lower at 88.20 euros by 1029 GMT (0529
ET).
Sanofi bought some time with a patent infringement lawsuit filed
last year against Eli Lilly and Co to keep a cheaper Lantus generic
off the market for 30 months.
In addition to gaining Toujeo patients through conversions, "there's
about a million new patients for basal insulin each and every year,"
said Joe Balzer, head of U.S. commercial operations for Toujeo,
which is awaiting a European approval decision.
Toujeo has the same active ingredient as Lantus, called insulin
glargine, but at three times the concentration and with a design to
release the insulin more gradually.
The medicine provides similar blood glucose control as Lantus with
significantly lower rates of hypoglycemia, a potentially dangerous
drop in blood sugar.
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Lantus is the world's most prescribed insulin with sales of $7.2
billion in 2014. Warnings of faltering U.S. Lantus sales contributed
to the sudden sacking of Sanofi Chief Executive Officer Chris
Viehbacher last year.
His successor, Olivier Brandicourt, is set to assume the top post at
the beginning of April as Toujeo goes on sale.
The company has not revealed a Toujeo price and declined to discuss
any potential discounting strategy in a market analysts see becoming
increasingly price sensitive.
More than 370 million people worldwide have diabetes, the
International Diabetes Federation says. As many as 95 percent have
type 2, often associated with obesity and which raises the risk of
numerous serious health problems.
(Reporting by Bill Berkrot in New York; Additional reporting by
Andrew Callus in Paris; Editing by Lisa Shumaker and Keith Weir)
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