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Amgen Enbrel Clears FDA For Psoriasis Supplemental Indication; Detailing Begins Immediately

This article was originally published in The Pink Sheet Daily

Executive Summary

The company calls on 3,500 dermatologists for its psoriatic arthritis indication; Amgen hopes to increase promotion to 9,000 dermatolgists.

Amgen will immediately begin detailing Enbrel (etanercept) for the treatment of chronic moderate to severe plaque psoriasis following its supplemental approval April 30.

The company has been detailing the biologic to 3,500 dermatologists for psoriatic arthritis, which was approved in 2002. Amgen plans to increase its promotion to up to 9,000 dermatologists.

Amgen anticipates a potential market size of 1.5 mil. patients.

If demand is significant, the product could again face supply constraints, especially considering that Genentech's contract facility is not on-line. Genentech markets the psoriasis product Raptiva .

Enbrel is the first TNF inhibitor with a psoriasis indication. J&J/Schering-Plough's Remicade is in Phase III for severe psoriasis and Abbott's Humira is in Phase III for psoriasis, with asupplemental BLA slated for 2005-2006.

- Lee Kalowski

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