Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.
Dynavax Technologies Corporation (DVAX) is striving hard to get its hepatitis B vaccine candidate, Heplisav, approved in the U.S. and EU.
The company submitted its responses to the Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (:EMA) in Dec 2013. The list was related to Dynavax's Marketing Authorization Application (MAA) for Heplisav.
However, Dynavax recently announced it has withdrawn its MAA for Heplisav as the Day 180 List of Outstanding Issues provided by the EMA suggested that the current safety database for Heplisav is too small to rule out a risk of less common serious adverse events.
Consequently, Dynavax decided to withdraw its MAA as the required timeframe for response under the regulatory process is not sufficient to collect the clinical data. Dynavax plans to initiate a trial, HBV-23, on Heplisav to provide a safety database sufficient to support licensure.
We remind investors that Dynavax suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (:FDA) asked for additional safety data in response to a meeting with the agency to discuss the complete response letter (CRL) received earlier in 2013 on Heplisav.
The phase III study, HBV-23 (n=8,000), is planned to provide a sufficiently-sized safety database for the FDA to complete its review of Biologic License Application (:BLA). The phase III study will evaluate the overall safety and immunogenicity of Heplisav as compared to GlaxoSmithKline’s (GSK) Engerix-B in adults in the age group of 18 to 70 years. The study is also expected to generate additional immunogenicity data on Heplisav in patients suffering from diabetes.
Since Dynavax does not have any other approved product in its portfolio, we expect investor focus to remain on Heplisav updates in the near term.