Shares of Dynavax Technologies Corp. (DVAX) jumped over 24% in after market hours following news that the company has met with the FDA to discuss its plans to resume development of its late-stage investigational hepatitis B vaccine Heplisav.
Heplisav has been on clinical hold since last March after a single case of Wegener's granulomatosis was reported in a phase III healthy adult study conducted outside the U.S. Wegener's granulomatosis is an uncommon disease in which the blood vessels are inflamed. The vaccine is studied for both healthy adults and patients with end-stage renal disease. However, there are no clinical holds on Heplisav outside the U.S.
In October 2008, the regulatory agency requested additional information prior to considering further development of Heplisav in end-stage renal disease patients but advised that the balance of risk versus potential benefit no longer favors continued clinical evaluation of Heplisav in healthy adults and children.
In the wake of regulatory issues, Merck, which had licensed exclusive worldwide rights to Heplisav from Dynavax, terminated its partnership on December 19, 2008 and handed over all the rights back to Dynavax. The licensing deal was worth $31.5 million up front and up to $105 million in milestone payments. Dynavax shares got hammered and fell 30.5% to close at $1.07 on December 19.
At the 44th Annual Meeting of the European Association for the Study of Liver Disease in Copenhagen, Denmark on April 27, 2009 Dynavax presented additional phase III clinical data of Heplisav, which demonstrated the vaccine's potential to provide more rapid and increased protection against hepatitis B viral infection and with fewer doses than the licensed vaccine Engerix-B, manufactured by GlaxoSmithKline plc (GSK).
During its meeting with the FDA, Dynavax proposed the continued clinical development of Heplisav in populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups such as individuals infected with HIV or diagnosed with chronic liver disease. The company noted that the FDA has agreed to its proposal, pending the review of the study protocols and additional supportive data.
Dynavax plans to submit study protocols and additional supportive data related to Heplisav to the FDA this month with a goal of having the agency remove the clinical hold in September 2009. The company said it is prepared to restart clinical trials in individuals with chronic kidney disease upon removal of the clinical hold.
If the clinical hold is lifted, Dynavax may seek a new partner for the development of Heplisav, a Toll-like receptor agonist. Dynavax already has a potential $800 million worldwide strategic alliance with GlaxoSmithKline for its TLR (Toll-like receptor inhibitor) therapies and it remains to be seen if GlaxoSmithKline agrees to partner in the development program of Heplisav. At June 30, 2009 the company had a total cash of $53.0 million.
The company's other investigational drugs are phase Ib product -- SD-101 for hepatitis C and DV-601, which is about to enter a phase Ib clinical trial for hepatitis B. Dynavax' preclinical programs include Universal Flu vaccine being developed under a global supply and option agreement with Novartis AG (NVS) and AZD1419, an experimental drug for the treatment of asthma and chronic obstructive pulmonary disease developed in partnership with AstraZeneca plc (AZN).
DVAX, which has thus far hit a 52-week low of $0.15 and 52-week high of $2.60, closed Tuesday's trade at $1.83. In after-hours, the stock was up 24.59% to $2.28.
Dynavax remains confident about its investigational hepatitis B vaccine Heplisav. Will patience pay off for Dynavax? Stay tuned...
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