Nov 13 New U.S. guidelines on heart health that
favor potent statins may threaten use or even approval of a hot
new class of experimental cholesterol drugs that have been
billed as revolutionary new treatments with blockbuster sales
potential, analysts said on Wednesday.
Pfizer Inc, Amgen Inc and a partnership of
Regeneron Inc and French drugmaker Sanofi SA
are racing to develop the new family of medicines called PCSK9
The injectable drugs in mid-stage trials have slashed levels
of "bad" LDL cholesterol 60 percent beyond reductions seen with
statins alone. The new medicines work by blocking a protein
called PCSK9, whose natural function is to maintain the presence
of LDL in the bloodstream.
"I read the new guidelines as a negative for any drugs that
aren't statins, including PCSK9 inhibitors," said Jon LeCroy, an
analyst with MKM Partners.
The guidelines issued by two leading U.S. medical
organizations on Tuesday recommend strong measures for patients
at particularly high risk of heart attack or stroke, including
more aggressive therapy with statins that lower cholesterol. In
fact, statins are the only class of cholestrol-lowering
medicines that the guidelines recommend for patients who can
The guidelines dropped an emphasis on specific targets for
lowering LDL levels. Instead, they suggest that individual
patient risk of developing heart disease rather than an LDL
number should be used to determine the need for more intensive
The drugmakers are hoping the U.S. Food and Drug
Administration will approve their PCSK9 inhibitors on the basis
of their ability to lower LDL. In the meantime, they are
conducting costly ongoing trials, called "outcomes studies," to
eventually prove to regulators that their medicines actually
lower the risk of heart attack and stroke.
Mark Schoenebaum, an analyst with ISI Group, said the new
heart-protection guidelines "appear to raise the bar for
cholesterol-lowering drugs" that are not statins. He said use of
Amgen's PCSK9 inhibitor, called AMG 145, if it is approved,
could be slowed until data from the drug's outcomes trial arrive
in late 2017 or early 2018.
Moreover, Schoenebaum said it remains to be seen whether the
new guidelines, formulated by the American Heart Association and
the American College of Cardiology, will affect the willingness
of U.S. and European regulators to approve the new class of
LITTLE DAMAGE SEEN FOR ZETIA, VYTORIN
Schoenebaum said Wall Street has been expecting the Amgen
drug to generate sales of $1.1 billion in 2018. For now, he said
he was sticking to his own sales forecast of $500 million that
year, growing to more than $1.4 billion in 2020.
"Given the (heart) guidelines, we remain comfortable with
our estimates for now, but will monitor how the guidelines are
perceived by the wider medical community," Schoenebaum said in a
Leading statins include generic forms of Pfizer Inc's
Lipitor, whose chemical name is atorvastatin, and
AstraZeneca's branded Crestor.
Other analysts said the new guidelines should not greatly
hurt sales of Zetia and Vytorin, two blockbuster cholesterol
fighters sold by Merck & Co that are not statins.
Instead of cutting the body's production of LDL, as statins do,
they prevent the intestines from absorbing LDL.
The analysts said most doctors already prescribing the two
Merck drugs will probably continue to do so for the next year,
until the medical community gets better acquainted with the new
Moreover, they said data from Zetia's own outcomes trial is
expected in the third quarter of 2014, and will definitively
show whether it prevents heart attack and stroke.
"I don't think sales of Zetia and Vytorin will fall away
rapidly," said Atlantic Equities analyst Richard Purkiss. He
said most doctors will wait for the Zetia trial results before
abandoning the drug and Vytorin, which pairs Zetia with Merck's
Analysts said sales of AstraZeneca's Crestor were unlikely
to get a big boost from the new guidelines because most doctors
would reach instead for generic atorvastatin, which is far
cheaper than Crestor and has similar potency.
Shares of Regeneron fell 3.6 percent, while Amgen slipped
0.6 percent, both in morning trading on the Nasdaq. Pfizer rose
0.5 percent and Merck dropped 1 percent on the New York Stock
Exchange, while Sanofi fell 0.5 percent in Paris. AstraZeneca
shares slipped 0.4 percent in London.