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Regeneron Says FDA Delays Decision on Eylea Blindness Drug

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Aug. 16 (Bloomberg) -- Regeneron Pharmaceuticals Inc. declined as much as 13 percent in extended trading after U.S. regulators delayed a decision on whether to approve the company’s treatment for a common cause of blindness.

The Food and Drug Administration extended its target date to complete its review of the medicine by three months to Nov. 18, the Tarrytown, New York-based company said today in a statement.

The drug, known as Eylea, would compete with Lucentis from Basel, Switzerland-based Roche Holding AG. Eylea is injected every eight weeks, half as often as Lucentis. The less frequent dosing would help Regeneron capture 25 percent of the U.S. market from Lucentis, Edward Tenthoff, a senior research analyst with Piper Jaffray & Co. in New York, said yesterday in a note to investors.

The FDA’s extension “is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing, and controls section” of the company’s application to sell Eylea “as a major amendment” to the application, Regeneron said in the statement. German drugmaker Bayer AG is a partner on the drug and in June filed a marketing application in Europe.

Regeneron declined $7.42, or 13 percent, to $50 at 6:50 p.m. New York time in extended trading after falling 75 cents to $57.42 at the close of the Nasdaq Stock Market. The shares have gained 75 percent this year.

Unanimous Recommendation

A panel of outside advisers to the FDA voted 10-0 in June to back Eylea as safe and effective for treating wet age-related macular degeneration, a leading cause of blindness affecting more than 1 million Americans. The FDA isn’t required to follow the advisory panel’s recommendations. The drug, with the chemical name of aflibercept, was previously known as VEGF Trap-Eye.

Sales of Eylea, if approved, may reach $1.2 billion in 2016, Tenthoff said.

Sixty percent of Medicare beneficiaries with macular degeneration took Roche’s cancer drug Avastin for the disease in 2008, Philip Rosenfeld, a University of Miami Miller School of Medicine ophthalmologist, said last month at a Senate hearing on drug pricing. Avastin isn’t FDA-approved for the eye disorder though it may be prescribed “off-label” by physicians.

Lucentis costs as much as $2,000 for each monthly injection compared with less than $50 a dose of Avastin, Jonathan Blum, deputy administrator at the Centers for Medicare and Medicaid Services, said at last month’s hearing.

Lucentis Sales

“Lucentis is on track for $1.9 billion in sales in the U.S. this year, despite that massive Avastin cannibalization,” Tenthoff said in an interview. Eylea may cost slightly less than Lucentis, he said.

Democratic Senators Herb Kohl of Wisconsin and Sherrod Brown of Ohio are asking the Medicare program to declare Avastin necessary to fight wet age-related macular degeneration.

Kohl and Brown seek a “national coverage determination” that would give doctors and patients confidence Avastin is safe and effective, said Ken Willis, a spokesman for the Senate Aging Committee, which Kohl heads. “We want to save money for taxpayers and consumers,” he said. “We want drugs to be as affordable as possible.”

Roche points to studies at Duke University in Durham, North Carolina, and Baltimore-based Johns Hopkins University that used Medicare claims data to show the use of Avastin for the eye condition increases the risk of stroke and death in seniors. Roche funded the Johns Hopkins study.

((Go to LIVE <GO> to listen to Regeneron’s conference call at 8:30 a.m. New York time tomorrow to discuss the FDA’s action.))

To contact the reporters on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net; Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.

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