(New throughout, adds filing details, background, share price)
Aug 28 Amgen Inc said on Thursday it
applied to U.S. health regulators to sell its cholesterol
fighter, evolocumab, becoming the first company to seek approval
of a medicine from a closely watched new class of potent heart
Amgen is racing with Regeneron Inc to bring to
market the potentially lucrative new drugs aimed at patients
unable to tolerate widely used statins, and those who cannot
sufficiently lower cholesterol despite use of statins, such as
Pfizer Inc's Lipitor, or other medicines.
The injectable drugs work by blocking a naturally occurring
protein called PCSK9 that prevents the liver from removing LDL
cholesterol, the "bad" cholesterol, from the bloodstream.
In large clinical trials, evolocumab cut LDL levels by more
than 50 percent even in patients already taking other
Analysts have forecast multibillion-dollar sales for the new
biotech drugs, if they demonstrate an ability to significantly
reduce heart attacks and deaths in larger ongoing trials, as
While Amgen was the first to file for U.S. approval of a
PCSK9 inhibitor, Regeneron and French partner Sanofi
have an ace up their sleeve that could enable them to catch up
or even reach the market first with their drug, alirocumab.
In late July, the companies said they paid $67.5 million to
acquire a special voucher from BioMarin Pharmaceutical Inc
that could assure alirocumab an expedited six-month
U.S. regulatory review, rather than the standard 10 months.
Pfizer Inc is also developing a PCSK9 inhibitor, but
is behind Amgen and Regeneron.
Amgen is expected submit approval applications for
evolocumab to regulators in Europe and other markets in the
Amgen shares were up 77 cents, or 0.6 percent, at $138.60,
while Regeneron shares were off 76 cents, or 0.2 percent, at
$349.25 on Nasdaq.
(Reporting by Bill Berkrot; additional reporting by Natalie
Grover in Bangalore; Editing by Maju Samuel and David Gregorio)