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SMF Notes HGSI Human Genome: Benlysta PDUFA: Successful as anticipated - Stifel (25.68 )
HGSI Human Genome: Benlysta PDUFA: Successful as anticipated - Stifel (25.68 ) -Update-
Stifel notes that (as they anticipated), Benlysta gained U.S. approval for the treatment of active, autoantibody-positive lupus patients. They find Benlysta's label to be largely clean, without any black box warnings or explicit restrictions on usage in African Americans. Having said this, efficacy in this sub-population was not confirmed in the label, however, HGSI will undertake a Phase IV study to further address this issue. They are also encouraged by the label's inclusion of steroid sparing and flare reduction data from clinical trials of Benlysta. Finally, other than a medication guide, there are no onerous REMS requirements. They estimate 2011 U.S. market penetration of 1.5% growing to 23.2% by 2015. This translates to 2011 U.S. Benlysta revs of $117 mn, growing to $2.3 bn by 2015. They continue anticipating an ex-U.S. approval in 3Q:11.
Stifel notes that (as they anticipated), Benlysta gained U.S. approval for the treatment of active, autoantibody-positive lupus patients. They find Benlysta's label to be largely clean, without any black box warnings or explicit restrictions on usage in African Americans. Having said this, efficacy in this sub-population was not confirmed in the label, however, HGSI will undertake a Phase IV study to further address this issue. They are also encouraged by the label's inclusion of steroid sparing and flare reduction data from clinical trials of Benlysta. Finally, other than a medication guide, there are no onerous REMS requirements. They estimate 2011 U.S. market penetration of 1.5% growing to 23.2% by 2015. This translates to 2011 U.S. Benlysta revs of $117 mn, growing to $2.3 bn by 2015. They continue anticipating an ex-U.S. approval in 3Q:11.
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