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Dynavax and Merck & Co team up for phase III Hep B vaccine

US-based Dynavax Technologies and Merck & Co have revealed a global license and development collaboration agreement to jointly develop Heplisav, a hepatitis B vaccine currently in phase III clinical trials for patients on dialysis.

US-based Dynavax Technologies and Merck & Co have revealed a global license and development collaboration agreement to jointly develop Heplisav, a hepatitis B vaccine currently in phase III clinical trials for patients on dialysis.

Per the agreement, Merck & Co will gain worldwide exclusive rights to Heplisav. The company will fund future vaccine development and also be responsible for commercialisation.

Dynavax will receive an initial payment of USD 31.5m and could also receive up to USD 105m in development and sales milestone payments, as well as double-digit tiered royalties on global sales of the vaccine.

Dynavax will continue to manage ongoing phase III studies in Canada and the EU, as well as other licensure-required studies.

The FDA's Biologics Licensing Application (BLA) and other marketing applications will be the joint responsibility of Merck & Co and Dynavax, and will be filed by the former company.

Dynavax will be responsible for manufacture of the hepatitis B surface antigen component of the vaccine for Merck & Co, which will be produced at Dynavax Europe's Germany-based facility using the company's proprietary technology. Production of the vaccine will be expanded at a new facility to support expected market needs, according to Dynavax.

Dino Dina, CEO of Dynavax, said: "In clinical trials to date, Heplisav has conferred immunogenicity after only two doses while retaining tolerability comparable to a currently marketed hepatitis B vaccine. We wanted to partner with Merck given its commitment to public health and leadership in bringing innovative vaccines to the market. Importantly, we expect it to be the first marketed product containing a novel Toll-Like Receptor 9 agonist."

Margaret G McGlynn, president of Merck & Co's vaccines and infectious disease arm, added: "Merck has been a leader in the field of hepatitis B prevention since we introduced the first recombinant vaccine, Recombivax HB in 1986. Through this collaboration with Dynavax, we have now gained rights to Heplisav, and as a result, have the potential to add another important advance to Merck's broad portfolio of vaccines."

Hepatitis B is one of the world's most serious and widespread chronic diseases. According to the University of Edinburgh, the global hepatitis B vaccine market now exceeds USD 1bn annually and is expected to continue to grow as more countries adopt World Health Organisation (WHO) recommendations for the routine vaccination of newborns, teenagers, healthcare workers and at-risk sub-groups.

30th September 2008

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