While Optimism Surrounds Dynavax’s Heplisav, Challenges to Its Commercial Success Still Remain

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On October 17, 2013, Dynavax Technologies Corporation announced detailed plans for a pivotal Phase III clinical trial involving its much-anticipated hepatitis B virus (HBV) vaccine candidate, Heplisav. With this large-scale Phase III study (HBV-23), which is expected to enroll over 8,000 participants beginning in early 2014, Dynavax seeks to address a complete response letter issued by the Food and Drug Administration (FDA) in June 2013, in which the FDA refused to grant Heplisav a broader indication without additional safety data. Key opinion leaders (KOLs) have indicated to GlobalData that, while the results from HBV-23 will likely alleviate the FDA’s concerns and lead to Heplisav’s approval, Dynavax’s commercialization efforts will ultimately fail unless it focuses on increasing HBV vaccine uptake in key segments of the adult population where the need for Heplisav is strongest, such as adults with end-stage renal disease (ESRD), diabetes mellitus, and compromised immune systems.

Despite official recommendations from the Centers for Disease Control and Prevention (CDC) calling for the vaccination of all high-risk adults, KOLs cite several factors that have contributed to low HBV vaccine uptake in these populations. From a clinical perspective, many of these patients, termed “non-responders”, fail to achieve high levels of seroconversion when administered the currently marketed, non-adjuvanted HBV vaccines. Dynavax has recognized this attractive opportunity and focused its initial Phase III clinical trials on specific non-responders, such as patients with chronic kidney disease (CKD). With HBV-23, Dynavax also hopes to examine its adjuvanted vaccine’s immunogenicity in adults with diabetes mellitus, which together with other non-responders represents an enormous, yet largely untapped, segment of the HBV vaccine market...

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