Tuesday, November 20, 2012

How The Compounding Scandal Benefits One Drugmaker

Pharma & Healthcare
|11/19/2012 @ 4:07PM
One company’s pain is another company’s gain. For the past few years, a significant number of ophthalmologists have used the Avastin cancer medication to treat age-related macular generation, a common afflication among the elderly, even though the drug was never approved for this use. Avastin gained popularity because, until recently, the only alternative was another Roche drug called Lucentis, which is about 40 times more expensive for each injection.

Howeve, the off-label use of Avastin prompted concerns – particularly from Roche, which wanted the bigger sales associated with the higher-priced Lucentis - because rejiggering Avastin into vials was linked to reports of infections and blindness. At one point, the US Department of Veteran Affairs suspended Avastin usage for treating wet AMD (back story). But the landscape changed a year ago when the FDA approved yet another drug for wet AMD, Eylea, which is sold by Regeneron Pharmaceuticals.
In the recently ended third quarter, Eylea captured roughly one-third of the branded market share for wet AMD, according to Regeneron ceo Leonard Schleifer. Moreover, the branded market is growing, he believes, because there were additional indications for Lucentis for treating diabetic macular edema, the patient population expanded due to age and more patients switched from Avastin. “The market dynamics are not stagnant,” he said at the recent Credit Suisse Healthcare Conference (see this).
Yet another dynamic is shifting quickly. Thanks to medicines made by the New England Compounding Center, which led to an outbreak of fungal meningitis that has claimed 33 lives (look here), there is increased betting that Eylea will capture still more market share, since compounded Avastin is used by ophthalmologists to treat wet AMD. “I think there will be regulation,” Schleifer predicted. “And… anything that would make Avastin safer would be good for our patients and our doctors.”
Indeed, the NECC scandal has been cited as an example in which compounded Avastin may be worrisome. In 2006, the FDA sent a warning letter to the compounder that cited, among other things, concerns about marketing anesthetic creams and potential microbial contamination associated with splitting and repackaging Avastin. The agency also tagged NECC for sending promotional to ophthalmologists, when the drug was not approved for wet AMD (see here).

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