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news.Dynavax Technologies has announced the termination of a global license and development collaboration agreement with Merck & Company for Heplisav, a Phase III hepatitis B virus vaccine. All rights to develop and commercialize Heplisav revert to Dynavax.
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Dynavax said that it will continue to evaluate regulatory options for the development of Heplisav indicated for adults outside of the US and for the global end-stage renal disease markets, which the company estimates represent approximately 70% of the total market opportunity for this vaccine.
If the regulatory feedback is favorable, Dynavax plans to pursue a new partner or financing arrangement to support the completion of Heplisav’s development for these markets.
Dino Dina, president and CEO of Dynavax, said: “We believe the economics for Heplisav, which has been shown to be clinically superior in our trials, favor identifying an appropriate regulatory path in the US and Europe. In the first quarter of 2009, we expect to gain additional insight into the regulatory path for Heplisav that will enable us to evaluate further development and pursue partnering agreements with potential collaborators or investors.”