Genentech to curb Avastin sales for eye illness
LOS ANGELES |
LOS ANGELES (Reuters) - Genentech Inc said on Thursday it will ban on November 30 direct purchases of Avastin by independent compounding pharmacies, which repackage the cancer drug as a low-cost substitute for its newer eye drug, Lucentis.
Avastin is chemically similar to Lucentis, Genentech's approved drug for treating wet, age-related macular degeneration, a condition in which bleeding under the retina harms vision.
The move by Genentech, which underscores that Avastin is approved as a cancer treatment and not approved for ophthalmological uses, would ban wholesale distributors from selling Avastin directly to independent compounding pharmacies.
The U.S. Food and Drug Administration has warned compounding centers that their products are not "generally recognized, among experts ... as safe and effective" and that they are viewed as "new drugs" that would require FDA approval, according to a letter available on the agency's Web site.
FDA did not immediately respond to calls seeking comment as to whether any safety issues have arisen.
Avastin has been broadly used in the United States and Europe as an off-label treatment for macular degeneration because the cost of a one-month supply of Avastin packaged for eye use is about 40 to 50 times lower than the $2,000 price for a comparable dose of Lucentis.
In the June quarter, Genentech reported Avastin sales of $564 million and Lucentis sales of $209 million.
Genentech, which is majority owned by Swiss drugmaker Roche Holding AG, developed each of the drugs and retained U.S. commercial rights for each.
Last month, health insurers in Germany said they were promoting the use of Avastin over Lucentis.
The move pit Roche, which has Avastin marketing rights outside the United States, against Novartis, which has non-U.S. commercial rights for Lucentis.
U.S. insurers say they are in a bind because there is no clinical data available to support coverage of Avastin for macular degeneration.
To that end, the National Eye Institute and National Institutes of Health are conducting a head-to-head trial comparing Avastin and Lucentis as treatments for macular degeneration.
Britain's National Health Service is also funding a similar trial in a bid to contain rising health-care costs, which are being driven by technology, drug costs and other factors.
(Reporting by Lisa Baertlein)
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