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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Heplisav clinical hold may be released in near future: Positive Phase III results for Dynavax's hepatitis B vaccine Heplisav bring the firm closer to submitting a response to FDA's clinical hold on the TLR9-based drug, the company says Aug. 6. FDA placed Dynavax/Merck's Heplisav on clinical hold in March after one subject came down with a rare inflammatory disease. Dynavax said the response should be complete in the "near future." In the Phase III Heplisav Short-regimen Trial (PHAST) of 2,427 patients in Germany and Canada ages 11-55, 95 percent of subjects dosed twice with Heplisav developed antibodies against HBV after 12 weeks. Of patients dosed three times with the standard HBV vaccine, GlaxoSmithKline's Engerix-B, 81 percent developed antibodies after 28 weeks. Full results will be released later. Susquehanna analyst Derek Jellinek predicted the total development plan will be delayed by at least two quarters and expects an update in two to four months. Merck had initially estimated an NDA filing in 2010 (1Pharmaceutical Approvals Monthly January 2008, p. 13)

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September 2010 Approvals



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