"Dynavax Technologies Corp. said Friday its partnership with Merck & Co. to develop Heplisav, a hepatitis B vaccine candidate that has been stalled in the U.S. by safety issues, is over.
Dynavax retains all the rights to develop and bring Heplisav to market, and it said it will continue to evaluate its options in bringing Heplisav to markets outside the U.S. According to Dynavax, foreign markets offer 70 percent of the potential market for the drug.
In premarket trading, Dynavax shares fell 29 cents, or 18.8 percent, to $1.25.
In March, the Food and Drug Administration halted all studies of Heplisav after one trial patient was diagnosed with Wegener's granulomatosis, a rare disease that causes blood vessels to inflame. In October, the FDA told Dynavax and Merck that the risks of testing Heplisav on healthy patients outweigh the benefits, although it is willing to consider approving the drug in patients with kidney failure.
There are no holds on Heplisav testing outside the U.S., Dynavax said. The company said it expects to get more insight into regulatory paths for the drug in the first quarter of 2009.
Dynavax and Merck entered their partnership in November 2007. Merck paid Dynavax $31.5 million upfront, and Dynavax could have received up to $105 million in payments as the drug, already in late stage testing, advanced through development and sales milestones. Dynavax was also set to receive double-digit royalties on worldwide sales."
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