'Overwhelming approval' in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27 February 2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity of Dynavax Technologies’ (Nasdaq: DVAX) hepatitis B virus (HBV) vaccine Heplisav in specific adult populations, and the drug’s ability to address a key unmet need will lead to its “overwhelming approval” once legitimate safety concerns are alleviated, says an analyst with research and consulting firm GlobalData.

Christopher Pace, GlobalData’s analyst covering infectious diseases, states that if Dynavax builds a successful safety database for Heplisav, then US and EU regulators will be hard-pressed to ignore the drug’s unparalleled immunogenicity in adults, especially those who do not respond to available vaccines.

Peak sales of $85 million forecast by GlobalData, vs $700 million by Dynavax

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