* Treats a common cause of age-related blindness
* FDA expected to make final decision by Aug. 20
* Avastin could still have price advantage
* Regeneron shares fall 4.8 percent
* Analyst says favorable review was already priced in
(Updates shares to close, edits throughout)
By Anna Yukhananov
COLLEGE PARK, Md., June 17 A new eye medicine
from Regeneron Pharmaceuticals Inc (REGN.O) and Bayer AG
(BAYGn.DE) is safe and effective for treating a common cause of
vision loss, a panel of U.S. experts said on Friday.
The Food and Drug Administration advisory panel voted
unanimously to recommend Eylea as a treatment for the most
serious form of macular degeneration that affects at least 1.5
The advisers also said the injected drug could be given
once every two months, giving it an edge over the typical
monthly dosing of its chief competitor, Lucentis, from Roche
Holding AG ROG.VX.
"The data is very compelling for equivalence (with
Lucentis)," said Dr. Lynn Gordon, a panel member and associate
professor at the University of California in Los Angeles.
The FDA usually follows the advice of its advisory panels
and is expected to rule on Eylea by Aug. 20.
Regeneron shares, halted much of Friday pending the
advisory panel decision, lost 4.8 percent on Nasdaq to close at
Jason Kantor of RBC Capital Markets said Regeneron's share
price had reflected an expected favorable opinion, so the
decline was likely a case of "selling on the news."
Kantor predicted the drug would fare well, but said the
main reason to own Regeneron is its array of antibodies being
developed for other diseases in partnership with French
drugmaker Sanofi SA (SASY.PA).
Age-related macular degeneration (AMD) is the leading cause
of blindness in the elderly, with the wet form the most
serious. Some 11 million Americans have signs of AMD.
Piper Jaffray analyst Edward Tenthoff sees Regeneron taking
25 percent of the U.S. market by 2016, with annual sales of
CHEAPER CANCER DRUG
Eylea and Lucentis could face competition from Roche's
cancer drug Avastin, a much less expensive medicine that is
often used by doctors to treat macular degeneration even though
it has not been approved by the FDA for that purpose.
The amount of Avastin needed for an eye injection costs
only around $50, against a U.S. price of $1,950 for Lucentis
and probably a similar price for Eylea. All three drugs work in
a similar way.
An April study showed Avastin was as effective as Lucentis,
though it had more side effects. [ID:nN28270369]
Eylea's advantage over both rivals may be its two-month
In clinical trials, Regeneron showed that Eylea injected
into the eye every two months was as effective as monthly doses
of Lucentis. The committee said monthly monitoring of patients
receiving Eylea was not necessary.
"I think many of my patients are looking for something they
can take less often, and that's the exciting possibility of
Eylea," said Dr. Jeffrey Heier, a clinical instructor of
ophthalmology at Harvard Medical School who spoke on behalf of
Regeneron has full marketing rights to the drug in the
United States and would share overseas profits equally with
Germany's Bayer if Eylea wins regulatory approval in other
"It's a particularly proud day for us because few companies
can go from the discovery of the molecule and take it to this
point," said Regeneron Chief Executive Officer Leonard
"We started out as good scientists and hopefully we can
become good manufacturers too."
(Additional reporting by Ransdell Pierson and Lisa Richwine;
Editing by Gerald E. McCormick and Tim Dobbyn)