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Dynavax up on Heplisav briefing docs

November 14, 2012 2:28 AM UTC

Dynavax Technologies Corp. (NASDAQ:DVAX) gained $0.56 (13%) to $4.74 on Tuesday after FDA reviewers said the company's HBV product Heplisav showed non-inferiority and a comparable safety profile to a marketed HBV vaccine. In the pivotal Phase III DV2-HBV-10 and DV2-HBV-16 trials, Heplisav met the primary endpoint of a non-inferior seroprotection rate at week 12 compared to Engerix-B at week 28 or 32. In HBV-16, Heplisav also met the co-primary endpoint of lot-to-lot consistency in immune response four weeks after the last dose for three consecutively manufactured lots of Heplisav. The reviewers said there were no significant differences in the safety profiles of Heplisav and Engerix-B, though the reviewers recommended postmarketing studies to further evaluate the potential for autoimmune adverse events with Heplisav in a larger population. In 2009, FDA lifted a clinical hold on Heplisav that had been in place since March 2008 after a single case of Wegener's granulomatosis was observed in a Phase III trial.

The comments came in briefing documents released ahead of Thursday's meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss a BLA for Heplisav to prevent HBV infection caused by all known subtypes in adults ages 18-70 years. The PDUFA date is Feb. 24, 2013. The product is hepatitis B surface antigen (HBsAg) given with immunostimulatory DNA sequences that target toll-like receptor 9 (TLR9). An MAA for the product is also under review in Europe to prevent HBV infection in adults and in patients with chronic kidney disease (CKD). GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Engerix-B. ...