(Adds that companies seeking priority regulatory review,
By Ransdell Pierson and Natalie Huet
NEW YORK/PARIS, July 30 A new drug being
developed by Sanofi SA and Regeneron Pharmaceuticals
Inc significantly cut cholesterol in nine late-stage
clinical trials, the companies said on Wednesday, and provided
the first glimpse of its potential to prevent heart attacks and
The injectable drug, alirocumab, is from a new class of
medicines called PCSK9 inhibitors, which are also being
developed by Amgen Inc and Pfizer Inc. If
approved, they could lower "bad" LDL cholesterol in a new way
and reap multibillion-dollar sales.
An interim safety analysis of one of the Phase III studies
showed patients on alirocumab were less prone, versus those on
placebo, to a combination of cardiovascular events, including
cardiac death, heart attack, stroke, and chest pain requiring
That ongoing 2,341-patient study, called Odyssey Long Term,
is expected to conclude early next year. Data were examined when
all patients had been in the trial for a year, and about 25
percent had reached 18 months of treatment.
No other drugmaker has released data suggesting reduced
cardiovascular risk from PCSK9 inhibitors.
But Regeneron Chief Executive Leonard Schleifer, in an
interview, played down the favorable cardiovascular data. He
said the trial was not designed to show reduced cardiovascular
risk, but to assess safety and effectiveness in lowering LDL.
"One should not draw any conclusions from this," Schleifer
said, adding that the definitive word on alirocumab's potential
to cut heart risk will come from an ongoing 18,000-patient study
called Odyssey Outcomes.
Schleifer said, however, the favorable cardiovascular data
offers encouragement that Sanofi and Regeneron are testing "the
PCSK9 inhibitors cut cholesterol by blocking a protein that
prevents the body from eliminating LDL from the bloodstream.
In earlier mid-stage studies, alirocumab and Amgen's own
anti-PCSK9 drug, when combined with statins, cut LDL by almost
70 percent beyond reductions seen with statins alone.
Data from the nine large Odyssey trials showed that after 24
weeks, LDL reductions with alirocumab were consistent with
results seen in previous trials.
The trials involve patients whose high LDL cholesterol
levels are not sufficiently controlled by statins and other
existing treatments, and patients who cannot tolerate statins or
who have a high cardiovascular risk.
In eight of the studies, all patients received alirocumab
in addition to standard treatments such as statins and Merck &
Sanofi and Regeneron plan to seek approvals for alirocumab
by year-end. The companies said they would seek a priority
review from U.S. regulators that would allow for an approval
decision in six months rather than the usual 10 months.
The most common side effects of alirocumab in the trials
included stuffy nose and upper respiratory tract infections.
Regeneron is best known for its hot-selling Eylea treatment
for macular degeneration. Late on Tuesday, it said U.S.
regulators had approved Eylea to treat diabetic macular edema.
Regeneron shares closed up 5.8 percent at $322.18 on Nasdaq,
while Sanofi shares were little changed.
(Additional reporting by Bill Berkrot; Editing by Peter