Yesterday, Dynavax Technologies Corp. (DVAX) announced that it has resumed the late-stage registration trial of its hepatitis B (HBV) vaccine Heplisav in patients with chronic kidney disease. The trial will enroll 600 patients. Heplisav will be tested against GlaxoSmithKline plc’s (GSK) Engerix-B.

The company intends to begin another late-stage registration trial in adults over 40 years of age in early 2010. Dynavax expects to complete both trials within the next 2 years. Management expects the vaccine to hit the market by the end of 2012 or early 2013.
 
As a reminder, Heplisav was on clinical hold in the U.S since March 17, 2008 following the occurrence of the severe adverse event (SAE) of Wegener’s granulomatosis. The SAE was reported in the phase III study in healthy adults conducted outside the US. Wegener’s granulomatosis is an uncommon disease which results in the inflammation of blood vessels. Heplisav is being studied in both healthy adults and patients with end-stage renal disease.
 
Consequent to the regulatory issues, the company’s partnership with Merck & Co. Inc. (MRK) for Heplisav ended on December 19, 2008. All rights relating to the development and commercialization of Heplisav reverted to Dynavax.
 
In October 2008 and February 2009, the US Food and Drug Administration (FDA) requested additional information prior to considering further development of Heplisav in end-stage renal disease patients (ESRD).
 
Subsequently, Dynavax presented additional phase III data on Heplisav in April 2009. The data demonstrated the vaccine’s potential to provide more rapid and increased protection with fewer doses against HBV than Engerix-B.
 
The company met with the FDA to discuss its plans to resume clinical development of Heplisav in August 2009 and the agency lifted the 18-month clinical hold on the vaccine the following month.
 
Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. The global market for adult hepatitis B vaccines is estimated at over $500 million annually.
 
The ESRD market is large and growing rapidly. However, it is not fully served by currently available vaccines. Many ESRD patients do not respond to traditional vaccination and some require boosters. We believe that Heplisav will go a long way in fulfilling this unmet need on hitting the market.
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