* VA looking into reports of infection with Avastin use
* Regeneron shares close up 9.2 percent on Eylea prospects
(Adds analyst comment, Eylea FDA action date, updates share
By Bill Berkrot and Ransdell Pierson
Sept 21 The U.S. Department of Veterans Affairs
said it has stopped using Roche's ROG.VX Avastin to treat a
sight-robbing eye disease as it looks into reports of increased
risk of infection.
Roche's Lucentis is specifically approved to treat wet
age-related macular degeneration -- the leading cause of
blindness in the elderly. But its multibillion-dollar a year
cancer drug Avastin, which works in a similar manner, is
increasingly being used off-label to treat the disease because
it costs a fraction of Lucentis when cut into the small doses
needed for the eye disease.
"The Department of Veterans Affairs (VA) has ceased
ophthalmologic use of Avastin pending the results of an ongoing
investigation and will advise its physicians to consider
alternate therapies," the VA said in a statement.
"Once the investigation is complete, VA will reassess how
Avastin and similar therapies may be made available for
ophthalmologic use and will issue further guidance."
Shares of Regeneron Pharmaceuticals Inc (REGN.O), which is
awaiting U.S. approval of its new Eylea drug for the condition,
rose to a new high.
"The fact that the VA made this decision shows that the
risk of substituting Avastin for Lucentis might be a little
greater than we thought before," said Morningstar analyst
"It definitely bodes well for Lucentis and for the
potential for Regeneron's eye drug Eylea," Migliore said.
Roche's Genentech unit, which makes both Avastin and
Lucentis, has long cautioned against splitting up Avastin doses
for the eye disease since the company never tested the drug for
But Lucentis costs about $2,000 for a dose, while the
cancer drug costs about $50 when used for macular degeneration,
leading many ophthalmologists to go with the dose splitting
option. While companies may only promote drugs for approved
uses, doctors are free to prescribe them as they see fit,
leading to unapproved, or off-label, use of many medicines.
Both Lucentis and Regeneron's Eylea have demonstrated an
ability to improve the sight of patients, not just slow
progression of the disease.
But there has been mounting government pressure to increase
use of Avastin for macular degeneration in an effort to cut
costs to Medicare and other health programs.
Results from a large U.S. government-sponsored study
released in April found that Avastin works just as well as
Lucentis for the eye disease, but had more side effects that
Roche spokesman Terence Hurley said the drugmaker believes
Lucentis -- not Avastin -- is the most appropriate medicine for
the eye condition.
"There is a growing body of evidence that suggests
injecting off-label Avastin into a person's eye may pose
greater risks than Lucentis," he said, citing potential for
infection and inflammation when the drug is split up.
"We do not believe that cost should be the only factor
considered when choosing a medicine," he added.
Regeneron spokesman Peter Dworkin declined to comment on
the Veterans Affairs decision, and whether it could ultimately
bolster demand for its Eylea.
Dworkin noted that an advisory panel to the U.S. Food and
Drug Administration in June unanimously recommended approval of
Eylea after reviewing its safety and effectiveness. The FDA is
expected to make its decision in November.
"Regeneron's Eylea stands to be well positioned in the
market if it does get approved because it's dosed half as
frequently and Lucentis and these are injections directly into
the eye, so patients obviously appreciate less dosing,"
Morningstar's Migliore said.
The VA treats millions of U.S. veterans in its hospitals
Regeneron shares closed up $5.93, or 9.2 percent, at $70.28
on Nasdaq after touching a new high of $79.90 earlier on
(Reporting by Bill Berkrot and Ransdell Pierson; additional
reporting by Alina Selyukh in Washington; Editing by Phil
Berlowitz and Carol Bishopric)