By Bill Berkrot
Jan 14 Regeneron Pharmaceuticals Inc
will report about $400 million in U.S. sales of its high-profile
eye drug Eylea for the fourth quarter of 2013, bringing the
total for the year to about $1.4 billion with lots of room for
future sales growth, the U.S. biotech company's chief executive
said on Tuesday.
Regeneron CEO Len Schleifer called the Eylea franchise far
from mature and said sales of the drug have "plenty of room for
growth" in both the United States and Europe through approvals
for additional uses and other initiatives.
Schleifer also said the company has the potential for five
major regulatory submissions or approvals in the next five
years, including expanded approvals for Eylea, as well as drugs
for rheumatoid arthritis, asthma, atopic dermatitis and its
closely watched drug to lower "bad" LDL cholesterol from a
highly promising new class of medicines called PCSK9 inhibitors.
Regeneron shares jumped more than 9 percent following
Schleifer's comments during a presentation at the JP Morgan
Healthcare Conference in San Francisco.
The $400 million in U.S. fourth-quarter sales is up from
$363 million in the third quarter despite holidays in the period
that cut down on doctor visits. Regeneron reports U.S. sales of
the drug used to treat wet age-related macular edema - the
leading cause of blindness in the elderly - while Bayer AG
sells Eylea in Europe.
Sales growth of Eylea has slowed from its rocket-like rise
following a late 2011 approval in part because patients who have
been taking the drug for several months typically move to
Regeneron expects applications seeking approval of the PCSK9
cholesterol fighter, alirocumab, to be filed in Europe in early
2015 and for the United States later that year, the CEO said.
Schleifer said he believes the drug could win initial
approval before completion of a lengthy heart safety study as
long as that study is well underway.
Regeneron is developing the drugs in its pipeline in
partnership with French drugmaker Sanofi, which owns
about 16 percent of the biotech and pays the lion's share of
research and development expenses for the joint projects.
Sanofi is expected to spend more than $1 billion on the
Regeneron pipeline in 2014, Schleifer said.
"We have lots going on," he added.
Regeneron shares were up $24.76, or 9.2 percent, at $293.44
in afternoon trading on Nasdaq. Sanofi rose 1.3 percent in