* FDA panel to meet on Nov. 13, FDA verdict due by year-end
* FDA staff cite risk of blood disorders, infections, cancer
* Shares down around 1 percent after the news
By Ben Hirschler and Natalie Huet
Nov 8 U.S. regulatory officials have raised
concerns about "multiple serious and potentially fatal safety
issues" in patients given Sanofi's new multiple
sclerosis drug Lemtrada, fuelling uncertainty about whether it
will be approved.
Food and Drug Administration (FDA) staff said in a report
prepared ahead of a Nov. 13 advisory panel that the risks might
be too great to justify approval in the world's biggest
pharmaceutical market, unless the drug showed "substantial
Lemtrada, an injectable treatment also known as alemtuzumab,
is one of two new Sanofi drugs for MS, an autoimmune disease
that attacks the central nervous system and affects more than 2
million people worldwide.
The FDA is expected to rule on the drug by the end of the
year. Lemtrada won marketing authorisation from the European
Commission in September, shortly after obtaining approval for
its MS pill Aubagio.
The current consensus for annual Lemtrada sales worldwide is
$752 million by 2018, according to forecasts compiled by Thomson
Shares in Sanofi fell as much as 2.5 percent after the
documents were posted on the FDA's website on Friday. By 1555
GMT, they had narrowed their loss and were down 0.8 percent at
"Briefing documents usually raise many questions that are
open for discussion at the upcoming meeting. But when we read
the document it is clearly more negative than usual," a
Paris-based trader said.
IMMUNE SYSTEM RISK
Multiple sclerosis is a chronic, often disabling disease
that attacks the central nervous system and can lead to
numbness, paralysis and loss of vision.
Lemtrada is given via an intravenous drip for five days and
for three days one year later. It is designed to re-programme
the immune system, but in doing so can make the body more
vulnerable to other diseases.
The FDA staff review cited risks of autoimmune diseases
including blood disorders, infections and cancer, and, noting
that these issues were "serious and potentially fatal", did not
recommend approval of Lemtrada "unless substantial clinical
Natixis analyst Beatrice Muzard said the FDA's note
signalled a greater risk that the drug might not reach the U.S.
But another Paris-based analyst, who declined to be named,
was less alarmed, pointing out that the side effects cited in
the note were already known.
"Our company is confident that Lemtrada offers an important
step forward in the way physicians and patients will think about
treating multiple sclerosis," a spokesman for Sanofi said in an
Sanofi acquired Lemtrada when it bought U.S. biotech firm
Genzyme for $20.1 billion in 2011. Lemtrada's prospects were at
centre-stage in that drawn-out takeover battle, leading to an
eventual deal that included listed contingent value rights
linked to Lemtrada's future success.