Hepatitis B vaccine propels Dynavax
The U. S. Food and Drug Administration removed a clinical hold for a vaccine to combat Hepatitis B following which the shares of Berkeley-based Dynavax Technologies Corp. jumped 50 percent in late session trades.
While the meetings with the FDA were important, Michael Ostrach, Dynavax's chief business officer and general counsel said, it was the "voluminous" and "extensive" data that ultimately convinced regulators to remove the hold on Heplisav.
Dynavax also has plans to launch a phase 3 trial in chronic kidney disease patients in the near term. It also has a trial on the cards involving adults over 40 years of age that will begin in early 2010.
Dino Dina, president and CEO of Dynavax said, "The success of our scientific approach to resolving the clinical hold on HEPLISAV allows us to resume development of our enhanced hepatitis B vaccine".
Although Dynavax has had discussions regarding other commercialization partners but after with the regulatory path now, the company is content in developing the product on their own. The company also expressed happiness over the increase in the amount of revenues that will be single handedly come to them.
Nevertheless the firm is always reaching out to potential partners for all their programs.
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