June 30, 2006
New Genentech eye drug approved
By Lisa Richwine
WASHINGTON (Reuters) - A Genentech Inc. drug that reversed
vision loss in some patients won U.S. approval on Friday for
treating the leading cause of blindness in the elderly.
Injected into the eye monthly, the drug Lucentis maintained
vision in 95 percent of patients with the wet form of
age-related macular degeneration (AMD) who were treated for 12
months. Eyesight improved in one-third of patients, the Food
and Drug Administration said.
"The 95 percent retention is higher retention than we've
seen with any other product to date," Dr. Wiley Chambers,
deputy director of the FDA's division of anti-infective and
ophthalmologic products, told reporters.
The patients who gained vision were able to read at least
three more lines on an eye chart after a year.
Sixty percent of patients who got a treatment other than
Lucentis maintained vision at 12 months, the FDA said.
Many industry analysts expect Lucentis to dominate the
market and provide tough competition for another AMD treatment,
Macugen from OSI Pharmaceuticals Inc. and Pfizer Inc.. Macugen
can be given every six weeks.
"Our expectation is that they will steal share from
Macugen. The data was significantly better for Lucentis than
for Macugen," said A.G. Edwards analyst Al Rauch, who follows
Novartis developed Lucentis with Genentech and has
exclusive rights to sell the drug outside the United States.
William Blair analyst John Sonnier, in a research report
earlier this month, said he expected Lucentis sales of $37.5
million in 2006 and $250 million in 2007.
Wet AMD, the most serious form, occurs when blood vessels
form behind the eye and begin to leak and block vision. Both
Lucentis and Macugen are injected into the eye to cut off
nutrients needed by those vessels to grow.
Some doctors have been using a similar Genentech drug -
cancer treatment Avastin - to treat wet AMD. They say it works
at a dose that is much cheaper than Lucentis. Genentech said
Lucentis will cost the average patient about $8,600 a year.
Rival Macugen costs about $5,400 a year, Genentech said.
Company officials also told analysts in a conference call
they expect about 85 percent of insured patients in the United
States to be eligible for reimbursement for Lucentis. Many
other patients, including the poor, will be given access to the
drug on a charitable basis.
An average patient will need about five to seven injections
per year, Genentech said. The FDA's Chambers said Lucentis
worked best when given once a month.
The most common side effects included eye pain,
inflammation and pressure. Serious problems were rare and
usually related to the injection procedure, the FDA said. They
included severe inflammation of the eye's interior and retinal
detachment or tears.
Lucentis is known generically as ranibizumab, and Macugen
is known by the generic name pegatinib.
An older treatment, Visudyne made by Canada's QLT Inc. and
co-marketed by Novartis, is injected into the bloodstream
usually via a shot in the arm. A light is shined on the eye to
activate the drug.
Shares of South San Francisco-based Genentech, which is
majority owned by Swiss drug maker Roche Holding AG, gained
nearly 2.1 percent to close at $81.80 on the New York Stock
(Additional reporting by Kim Dixon and Julie Steenhuysen in
Chicago and Ransdell Pierson in New York)