Biotech Values

[DewDiligence]

Here’s the Heplisav PR for archival purposes.
The $5M milestone and future considerations
aren’t doing much for the shares in AH trading.

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Coley Pharmaceutical Group Grants Dynavax License for Commercialization of HEPLISAV™

Thursday June 28, 4:02 pm ET

WELLESLEY, Mass. and BERKELEY, Calif., June 28 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY ) and Dynavax Technologies Corporation (Nasdaq: DVAX - News) today announced they have entered into a license agreement relating to certain TLR Therapeutics(TM) patents from Coley.

Under the terms of the agreement, Dynavax receives a non-exclusive license under Coley's immunostimulatory oligonucleotide patent estate for the commercialization of HEPLISAV(TM), a hepatitis B prophylactic vaccine, currently in Phase 3 clinical trials. Coley will receive a $5.0 million up-front payment. Coley is also eligible to receive up to an additional $5.0 million upon regulatory approvals of HEPLISAV, as well as royalty payments for any future sales of HEPLISAV.

About HEPLISAV and Hepatitis B

HEPLISAV is currently being evaluated in a Phase 3 clinical trial in Canada and in Europe. The multi-center trial, known as PHAST (Phase 3 HeplisAv Short-regimen Trial), is comparing a two-dose regimen of HEPLISAV administered at 0 and 1 month to the conventional three-dose regimen of Engerix-B®. The enrollment target of the study is approximately 2,000 subjects, ages 11 to 55 years. Dynavax expects to submit a BLA in 2008 for approval of the product with a database of approximately 4,000 patients

In several previous clinical studies, HEPLISAV has been shown to provide seroprotection against hepatitis B faster and with fewer doses than conventional hepatitis B vaccines. Additionally, HEPLISAV has provided 100% seroprotection in all subjects who have received the full regimen, including those who are difficult-to-immunize.
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