PARIS Dec 19 French drugmaker Sanofi
and its U.S. partner Regeneron are collaborating with
the American College of Cardiology (ACC) to identify patients
for clinical trials on alirocumab, their new cholesterol
treatment and potential blockbuster.
Under this agreement, the ACC will use its expertise in
clinical research and its extensive patient registries to
identify appropriate candidates for a cardiovascular outcomes
clinical trial, Sanofi said in a statement on Thursday.
This is the first time that the ACC's "Pinnacle" registry
will be used for clinical trial recruitment, and Sanofi hopes
accessing its millions of patient records will help it fully
enrol the trial, which seeks some 18,000 patients who recently
suffered an acute coronary syndrome.
Alirocumab is an injectable drug from a promising new class
of medicines called PCSK9 inhibitors that is also being
developed by Amgen Inc and other drugmakers. It has
been touted by industry analysts as a potential blockbuster that
could reap annual sales of over $3 billion.
PCSK9 drugs are mainly aimed at the millions of people who
either cannot tolerate statins such as Pfizer Inc's
Lipitor or AstraZeneca Plc's Crestor or who cannot get
their cholesterol levels under control with statins alone.
In the first of a dozen late-stage trials, alirocumab cut
levels of "bad" LDL cholesterol almost in half. The drug's
ultimate success will depend on longer-term studies, some of
which will only give results around 2018. But Sanofi and
Regeneron are hoping positive earlier data could get the drug
approved for some patients before then.