Sanofi, Regeneron's Anti-Cholesterol Drug Has Good Test Results
November 10 2011 - 10:21AM
Dow Jones News
French drug maker Sanofi SA (SNY) and U.S. biotech Regeneron
Pharmaceuticals Inc. (REGN) Thursday said their novel
anti-cholesterol drug REGN727 produced positive preliminary results
in mid-stage clinical tests.
The experimental injectable therapy is designed to fight
excessively high cholesterol, and belongs to a new class of
medicines that could become the biggest weapon against heart
disease since statins were introduced in the 1980s.
They work by blocking PCSK9, a protein whose natural function is
to preserve levels of "bad" LDL cholesterol in the bloodstream.
Regeneron and Sanofi said their REGN727 drug reduced bad LDL
cholesterol by between 30% and 65%, depending on dose, in one Phase
II trial that lasted 12 weeks and produced no serious bad side
effects from use of the drug.
In another Phase II trial, REGN727 reduced bad LDL cholesterol
by more than 65% after eight weeks' treatment.
A third study of the Phase II program is ongoing.
"The preliminary Phase II results with our anti-PCSK9 antibody
are very encouraging," said Elias Zerhouni, head of global research
and development at Sanofi.
"We look forward to analyzing and presenting the complete data
set and remain committed to advancing this program into Phase III
development as soon as possible."
Analysts say Sanofi and Regeneron now appear to have the lead in
developing a drug that goes after PCSK9.
Amgen Inc. (AMGN), Merck & Co. (MRK), Alnylam
Pharmaceuticals Inc. (ALNY) and a partnership between Bristol-Myers
Squibb Co. (BMY) and Isis Pharmaceuticals Inc. (ISIS) aren't far
behind, however, with rival drugs of their own.
The anti-PCSK9 medicines are expected to be used alongside
statins, such as Pfizer Inc.'s (PFE) Lipitor and AstraZeneca PLC's
(AZN) Crestor, for patients who don't achieve cholesterol-lowering
goals with statins alone.
They would also be used on their own for a much smaller group
who cannot tolerate statins, which are oral drugs that inhibit the
liver's production of LDL cholesterol.
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall@dowjones.com
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