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Post# of 252218
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Alias Born 10/18/2003

Re: None

Tuesday, 03/01/2011 10:50:07 PM

Tuesday, March 01, 2011 10:50:07 PM

Post# of 252218
From Barclays, We are reiterating our 1-Overweight rating on REGN following publication of a retrospective review of Lucentis vs Avastin safety in AMD and ahead of prospective data expected from the CATT study in 1H11. With some concern regarding implications of upcoming CATT data for the brand anti-VEGF market results of the retrospective analysis suggest potential incremental cardiovascular risk with Avastin. Results are consistent with prior Medicare claims data as well as feedback from retinal experts and if replicated in CATT could result in actual brand expansion in AMD where we expect REGNs VEGF-TRAP eye (VTE) to dominate.

The journal Ophthalmologica published online a retrospective analysis of arterial thromboembolic events (ATEs) in patients treated for AMD with Avastin vs Lucentis. The study by Carneiro et al involved a chart review of 378 consecutive patients treated with anti-VEGF monotherapy between December 2006 and January 2010 at Hospital Sao Joao in Portugal. Results suggested a significantly greater number of ATEs in patients treated with Avastin at 12.4% (12/97) vs Lucentis at 1.4% (3/219), p<0.00001. Review of baseline characteristics across groups suggests balance across age and visual acuity but with longer days of follow up and total injections with Avastin. Subsequent analysis controlling for a fixed follow time period and comparable injection burden suggests persistent of adverse Avastin trends.

Results from Portugal are supported by a recent larger review of 146,942 Medicare beneficiairies in the US where 19,026 patients receiving Lucentis and 21,815 patients receiving Avastin were seen to have differences in risk for stroke and mortality with hazard ratios much lower for Lucentis. Retinal expert feedback has suggested that potential systemic effects of Avastin are greater than with Lucentis, and we expect adverse trends in CATT to support renewed anti-VEGF brand dominance.

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