| NEW YORK
NEW YORK Feb 11 When Gilead Sciences Inc
declined to project 2014 revenue for its high-profile
new hepatitis C drug last week, its shares fell nearly 7 percent
over the next two days.
Wall Street analysts say investors were likely spooked by
the omission, concerned it could signal that sales of the new
drug, Sovaldi, might not approach sky-high forecasts.
On Tuesday, Gilead President and Chief Operating Officer
John Milligan again declined to predict sales of the medicine
that won U.S. marketing approval in December. But he also did
not dismiss analysts' record-shattering forecasts that the
treatment could rake in $5 billion to $6 billion in its first
year on the market.
"It would be unprecedented for a drug to launch at that
level, but because of the duration of therapy being short,
because of the number of patients who are out there who have the
disease, it's not unreasonable math to come to that conclusion,"
Milligan told Reuters on the sidelines at the Bio CEO & Investor
conference in New York.
"We're in early launch phase, just two months in, so it's
dangerous to extrapolate from two months. I can see the number
that's out there. I don't know if it's too high or too low based
on the dynamics," Milligan said.
Along with its fourth-quarter results released last week
, Gilead reported $139.4 million in Sovaldi sales
after less than one month on the market. The drug promises to
increase cure rates with a much shorter duration of treatment
and far fewer side effects than previous standard regimens.
"We've seen great enthusiasm from the doctors, and the
question is how long will they continue to bring those patients
in, what experience will they have as we get through this year?"
He noted that a rival hepatitis C regimen from AbbVie Inc
with an equally impressive cure rate could hit the
market this year and affect sales. But AbbVie's treatment
involves more drugs and many more pills a day, likely giving
Gilead a competitive edge.
Gilead this week applied for approval of a combination of
Sovaldi and an experimental antiviral drug, ledipasvir, that
would be taken as one pill once a day, which could also impact
In late stage clinical trials, the combination provided cure
rates well in excess of 90 percent, in some cases with as little
as eight weeks of treatment. It would allow patients to avoid
use of older hepatitis drugs that can cause troublesome side
Current standard treatment regimens take 24 to 48 weeks and
include injected interferon that causes miserable flu-like
symptoms, leading many patients to discontinue or delay
treatment, and ribavirin, which can cause anemia and other
unpleasant side effects.
It is widely believed that thousands of patients have put
off treating the virus in order to wait for new drugs such as
Gilead's. By being the first of the expected new wave of oral
hepatitis C treatments to market, many analysts believe that
Gilead will grab the lion's share of those "warehoused"
"Remember, patients who started in December haven't gotten
through their 12 weeks of therapy yet, so (doctors) haven't seen
that full experience of seeing patients cured and they really
won't understand that until we get into the mid part of this
year," Milligan said.
"So I encourage people not to get too far ahead of
themselves in thinking about that," he said of the
multibillion-dollar first-year Wall Street sales forecasts. "I
can understand the enthusiasm because you can get to pretty big
numbers in a hurry."