* Eylea sales slow as patients move to less-frequent dosing
* Regeneron to seek approval of Eylea use in diabetic eye
* Shares fall 6.1 pct
By Esha Dey and Bill Berkrot
Aug 6 The explosive growth in the sales of
Regeneron Pharmaceuticals Inc's Eylea eye drug slowed
in the second quarter as existing patients moved to
Shares of Regeneron fell 6.1 percent on Tuesday even though
the company said it plans to file for wider use of the
injectable drug later this year, following positive new trial
Analysts, who were already expecting positive data from the
trials targeted at diabetic macular edema (DME), focused on
Eylea's slowing sales growth. Regeneron's second-quarter profit
came in below Wall Street expectations.
"Positive results for Eylea in DME were widely expected by
the Street, though the filing is now coming earlier. Overall, 2Q
looks mixed to us," J.P. Morgan analyst Geoff Meacham wrote in a
Eylea was approved in November 2011 to treat wet age-related
macular degeneration - the leading cause of blindness in the
elderly - and has become one of the fastest-growing medicines in
the history of biotechnology.
U.S. sales of the drug rose 70 percent in the second quarter
to $330 million, slowing from growth of 153 percent in the first
quarter, the company reported on Tuesday.
"As the dosing interval increases, the number of doses per
quarter do decline, so we're dependent on getting new patients
into the marketplace," Chief Executive Leonard Schleifer said on
a conference call with analysts.
Eylea is given by injection into the eye every four weeks
for the first three months, but is subsequently only
administered every two months.
The company, betting on growing demand for the drug, raised
its 2013 sales estimate for Eylea to between $1.30 billion and
$1.35 billion from its earlier estimate of $1.25 billion to
Eylea has been steadily grabbing market share from Roche
Holding's similar drug Lucentis, leading Regeneron to
repeatedly increase Eylea sales forecasts since its approval.
Piper Jaffray analyst Edward Tenthoff on Tuesday predicted
U.S. Eylea sales will hit $1.89 billion in 2014, accompanied by
growing sales of the product in Europe, where sales are split
with Bayer AG.
Tenthoff called Tuesday's selloff a buying opportunity and
said he expects Regeneron shares to climb to $336 within 12
months, up from his earlier price target of $274 on the stock.
He said the company's array of experimental medicines, most
of which are being developed in partnership with French
drugmaker Sanofi SA, will continue to capture investor
"Eylea is a great drug, but Regeneron has 11 other
antibodies" in testing, he said, including drugs in late-stage
trials to treat rheumatoid arthritis and high levels of "bad"
EYLEA FOR DIABETICS
Two new late-stage trials showed Eylea significantly
improved vision in patients with DME compared to laser surgery.
With the new data, Regeneron said it planned to apply for
U.S. approval for Eylea to treat DME in 2013 - a year ahead of
its previously projected timeline.
DME is a major cause of blindness in younger and middle-aged
adults, with potentially more than 6 million treatable patients
worldwide and represents a huge potential market for Eylea.
Patients in the 2-year-long DME studies, called Vivid-DME
and Vista-DME, received either monthly injections of Eylea, or
injections every other month following a course of five monthly
Eylea treatment was compared with laser photocoagulation, a
type of laser surgery in which leaky blood vessels in the eye
are cauterized to stop the leakage that leads to vision loss.
In the Vista-DME trial, those who received monthly Eylea on
average were able to see 12.5 more letters on an eye chart test
after one year compared to before receiving treatment.
Those in the every-other-month group saw vision improve by
10.7 letters. That compared with a mean change of just 0.2
letters for the laser group.
In the Vivid-DME trial, the vision improvement was 10.5
letters for the Eylea monthly and 10.7 letters for less-frequent
dosing groups, versus 1.2 letters for those who received laser
All the results for Eylea were deemed by researchers to be
highly statistically significant.
Eylea was generally well tolerated in the studies with the
incidence of serious adverse side effects similar across all
three treatment groups, the company said.
Bayer also will apply this year for European approval to
Regeneron said on Tuesday that second quarter net income
rose to $87.4 million, or 79 cents a share, from $76.7 million,
or 70 cents a share, in the year ago period. Excluding items,
the company reported earnings per share of $1.73.
Revenue rose to $457.6 million from $304.4 million.
Shares of Regeneron closed down 6.1 percent to $254.50 on