Dynavax Technologies Corp. (DVAX) recently announced the commencement of a large-scale late-stage study of its hepatitis B vaccine (HBV) Heplisav. The trial will enroll 2,000 patients in Canada and the United States. Out of the 2,000 patients, 1,600 will be treated with Heplisav while the remaining patients will receive GlaxoSmithKline plc’s (GSK) HBV vaccine, Engerix-B.
The company expects to report data from this study in the first half of 2011. The large-scale study intends to show that Dynavax’s HBV vaccine is just as effective as Engerix-B, eight weeks after the last active dose.
The trial is also designed to show lot-to-lot consistency for immune response 28 days after the last dosing among three lots of Heplisav, consecutively manufactured at the company’s facility in Düsseldorf, Germany. Recently, the European Union permitted Dynavax to commercially produce hepatitis B surface antigen, a key component of Heplisav at the factory.
As a reminder, Dynavax is evaluating Heplisav in another late-stage trial in patients with chronic kidney disease. These two studies are aimed to fulfill licensure requirements in the U.S., Canada and Europe.
The company stated that the current hepatitis B vaccines require three doses over six months to be fully effective. Heplisav aims to provide increased, rapid protection, utilizing fewer doses than currently available vaccines.
The disease affects more than 350 million individuals globally. It is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. Currently, the global market for HBV therapeutics is estimated at over $1 billion annually and available therapies have limited efficacy.
Dynavax currently has a Zacks Rank #3 (Hold), implying that the stock is expected to perform in line with the broader U.S. equity market over the next one to three months. We are Neutral on the company in the long-term as well. The Neutral recommendation implies that the stock is expected to perform in line with the overall U.S. equity market over the next six to twelve months. Therefore, we advise investors to retain the stock over this time period.
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