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New Genentech eye drug approved

Posted on: Friday, 30 June 2006, 19:20 CDT

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 AG.

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 Exchange.

(Additional reporting by Kim Dixon and Julie Steenhuysen in Chicago and Ransdell Pierson in New York)

Source: REUTERS

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