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. ...

Yesterday, Dynavax Technologies Corp. (DVAX) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on its late-stage hepatitis B vaccine (HBV) Heplisav which is being developed for patients suffering from chronic kidney disease. As a reminder, Heplisav was on clinical hold in the U.S since Mar 17, 2008 following the report 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 U.S. Wegener's granulomatosis is an uncommon disease which results in the inflammation of blood vessels .The vaccine is being studied for both healthy adults and patients with end-stage renal disease. Consequent to the regulatory issues, the 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 Technologies Corp. (DVAX) is a biopharmaceutical company focused on drug development for the treatment and prevention of various infectious and inflammatory diseases.

The company was recently hit hard by a couple of major negative events: the clinical hold and the subsequent termination of the partnership with Merck (MRK) for Heplisav, a late stage candidate for Hepatitis B vaccine, and the discontinuation of the Tolamba program for allergy. Currently, Dynavax is in active discussions with regulatory agencies to resolve the FDA's clinical hold on Heplisav and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.

The deal with Glaxo is a big positive

In 4Q08, Dynavax and GlaxoSmithKline (GSK) signed a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases.

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Dynavax: Surge on Heplisav Phase III or Swine Flu? In early morning trading, Dynavax Technologies Corp. (DVAX) shares shot up dramatically (36%). However, we don't see a clear reason for that.The surge may be related to two pieces of news: phase III Heplisav data and the swine flu breakout.The first piece of news is about its phase III candidate Heplivsav. This morning, the company announced the oral presentation of additional phase III clinical data for Heplisav hepatitis B vaccine in a session for late-breaking abstracts at the 44th Annual Meeting of the European Association for the Study of Liver Disease (EASL) in Copenhagen, Denmark.In the presentation, Heplisav met its primary endpoint in this phase III trial and demonstrated the vaccine's potential to provide more rapid and increased protection against hepatitis B viral infection and with fewer doses than the licensed ...