For Roche, Some Tricky Safety News About Avastin
1 CommentBy Ed Silverman // October 19th, 2010 // 7:15 am
Nobody likes a conundrum, but that’s what Roche may face now that a new paper found that both Lucentis and Avastin were no riskier for treating age-related macular degeneration, or AMD, than two other therapies, including Pfizer’s Macugen. The paper, which was published in the Archives of Ophthalmology, reviewed nearly 147,000 Medicare beneficiaries who received treatment for AMD in 2005 and 2006, and who were tracked through 2007 for heart attacks, strokes and bleeding (see the abstract).
Here is the issue: Roche owns Genentech, which sells both Lucentis and Avastin, although only Lucentis is approved by the FDA to treat AMD. Nonetheless, the Avastin cancer med is used off-label by many ophthalmologists because it is much cheaper - about $1,950 versus $30 per dose. Genentech has argued Avastin should not be used for AMD over safety issues, although the pricing disparity has prompted Senate scrutiny of Medicare spending for Avastin (see this).
Then comes the tricky part: The paper also noted that, while both photodynamic therapy and Pfizer’s Macugen were not associated with serious adverse systemic effects in randomized controlled trials, the risk of systemic adverse events was lowest with Lucentis. Moreover, “after adjustment for patient characteristics, (the researchers) observed significantly lower hazards of all-cause mortality, incident myocardial infarction, and incident stroke with (Lucentis) therapy compared with (Avastin) therapy.”
This cuts a couple of ways. On one hand, Genentech can point to this secondary finding to bolster its case that Lucentis should be the therapy of choice for treating AMD, at least in the US. But elsewhere, the story may be a little different. That’s because Genentech signed a marketing deal in 2003 with Novartis, which can sell Lucentis anywhere outside of North America (take a look). And so even though Novartis owns one-third of Roche, the rivalry lives on and Novartis has the upper hand in the AMD wars in most parts of the world.
In the US, meanwhile, Roche and Genentech may want to trumpet the safety signals for Lucentis, their newer, more expensive med. But if they point to this recent study, they may do so at the expense of Avastin, which has failed in several clinical trials this year and is already faltering over concerns that FDA approval for treating breast cancer will be rescinded (see this). US sales fell 3 percent in the third quarter and concerns about further losses contributed to a recent decision to cut jobs (look here). Remember that last year, Avastin generated about $6.4 billion in revenue. So Roche and Genentech must tread carefully if they attempt to tout the results about Lucentis.
As an aside, the study was supported by a research agreement between OSI Eyetech, which is Pfizer’s commercialisation partner on Macugen, and Duke University.
Andy
Eh? Surely Roche is in no conundrum. Given that Avastin costs “$30 per dose” for this indication, it makes 65x as much money with Lucentis per patient. In the US, it’s a no-brainer to try to shift people onto the more expensive med. The sales contribution of AMD to Avastin sales is trivial given the low cost.
Outside the US, Roche receives royalties on Lucentis sales. Assuming the price difference is the same, unless the royalty rate is <1.5% (which would be absurd), it will still make more money per patient from Novartis’ sales of Lucentis than it would from Avastin.