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"Overwhelming Approval" In Store For Heplisav If Dynavax Delivers Sufficient Safety Data, Says Globaldata Analyst

2/26/2014 9:51:59 AM

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LONDON, UK (GlobalData), 26 February 2014 - Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity of Dynavax Technologies Corporation’s 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 J. Pace, Ph.D., 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.

Following its approval, GlobalData projects global peak-year sales of $85 million for Heplisav in 2022, thanks to its performance linking primarily to the US adult market.

Pace says: “Given the European Medicines Agency’s (EMA’s) anticipated request for additional safety data, Dynavax’s decision to withdraw its EMA application is not surprising and represents a wise strategic move.

“Last October, the company announced plans for HBV-23, a Phase III study that will assess Heplisav’s safety and immunogenicity in 8,000 additional patients. Although Dynavax must invest a significant amount of resources and capital in this trial, the US-based biotech has cleverly designed it to simultaneously evaluate Heplisav’s immunogenicity in attractive patient populations. The most notable of these will be adults with diabetes, who are at an increased risk of HBV infection.”

However, even if Heplisav wins regulatory approval easily, this will not guarantee the drug’s uptake and commercial success, according to key opinion leaders interviewed by GlobalData.

Pace continues: “There are a number of formidable barriers to HBV vaccine uptake in the adult population, such as poor physician knowledge of adult immunization recommendations, inadequate adult vaccine reimbursement frameworks, and reduced patient compliance.

“Following Heplisav’s approval, Dynavax will need to work alongside regulators and healthcare providers to overcome these barriers and ensure maximum uptake,” Pace concludes.

- Comments provided by Christopher J. Pace, Ph.D., GlobalData’s Analyst covering Infectious Diseases.

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