Biotech Values

[DewDiligence]

DNA has finally taken preemptive action against
off-label Avastin use for AMD, which has garnered
a ~50% share of the US AMD market by prescription
volume, but a tiny share of the market by dollar sales
due to the minuscule price per AMD dose. Will DNA’s
crude approach really work… or will it end up costing
DNA even more in public goodwill?

http://online.wsj.com/article/SB119213222981256309.html

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Genentech to Curb Avastin's Use
In Treating Eye Degeneration

By JACOB GOLDSTEIN
October 11, 2007 4:25 p.m.

Genentech Inc. said it will no longer make its cancer drug Avastin available to so-called compounding pharmacies in a bid to curb its widespread use in treating a degenerative eye disease -- which has cut into sales of the company's high-priced eye drug.

Although regulators haven't authorized Avastin's use against eye disease, it is chemically very similar to Genentech's Lucentis, which was approved last year to treat wet macular degeneration, a condition caused by an overgrowth of vessels in the retina that leak and damage vision. Compounding pharmacies re-package vials of Avastin into syringes that contain a once-monthly dose of the drug for use in the eye and cost about $40. A once-monthly dose of Lucentis costs about $2,000.

In the first six months of this year, U.S. sales of Avastin [for all indications] were $1.1 billion, and Lucentis sales were $420 million.

In a letter explaining the decision, Genentech pointed out that Lucentis was developed expressly for use in the eyes, and said the Food and Drug Administration has expressed safety concerns about the repackaging of Avastin for that use.

Avastin, which is sold through wholesalers, will continue to be available to hospital pharmacies and directly to doctors. But it won't be available to compounding pharmacies as of Nov. 30.

Anne Fung, a San Francisco ophthalmologist, said she worries that some doctors may try to do the repackaging work themselves without the proper safety equipment. "This move is taking it out of a regulated environment into an unregulated environment," she said. That could increase the risk of contamination and serious eye infections.

Dr. Fung, who said Avastin and Lucentis are split roughly 50-50 among macular-degeneration patients, said she would likely try to get Avastin from a hospital pharmacy for her patients. That could increase the cost of treating her patients.

Genentech spokeswoman Dawn Kalmar said most macular-degeneration patients are covered by Medicare, and said the company helps connect patients who can't cover their copayment -- which can be $400 a month for Lucentis -- with charities that help with payment.
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