Tuesday, August 6, 2013

Reuters: Global Markets: Sales of Regeneron's Eylea eye drug slow, shares drop

Reuters: Global Markets
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Sales of Regeneron's Eylea eye drug slow, shares drop
Aug 6th 2013, 15:17

By Esha Dey

Tue Aug 6, 2013 11:17am EDT

(Reuters) - The explosive growth in the sales of Regeneron Pharmaceuticals Inc's Eylea eye drug slowed in the second quarter as existing patients moved to less-frequent dosing, sending the company's shares down 6 percent in early trading.

The shares fell in spite of new trial data that could help the company file for a wider use of the drug later this year.

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 note.

Eylea was approved in November 2011 to treat wet age-related macular degeneration - the leading cause of blindness in the elderly.

U.S. sales of the drug rose 70 percent in the second quarter to $330 million. They had risen 153 percent in the previous quarter.

"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.

Betting on new uses for the drug, the company 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 $1.33 billion.

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.

DME TRIALS

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 two 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 injections.

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 treatment.

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 AG, which sells the drug outside the United States, also will apply this year for European approval to treat DME.

Shares of the company were down 6 percent to $255.30 in morning trade on the Nasdaq.

(Reporting by Bill Berkrot in New York and Esha Dey in Bangalore; Editing by Carol Bishopric and Sreejiraj Eluvangal)

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