Emergent Biosolutions, Valneva in Zika Vaccine Pact
Emergent BioSolutions, a Gaithersburg, Maryland-headquartered specialty biopharmaceutical company, has formed a licensing agreement with Valneva, a France-headquartered biotechnology company, for global exclusive rights to Valneva’s Zika vaccine technology, ZIKV.
Emergent and Valneva plan to co-develop ZIKV-VLA1601, a purified inactivated vaccine candidate against the Zika virus, from preclinical development through completion of a Phase I safety and immunogenicity clinical trial. ZIKV-VLA1601 is based on Valneva’s inactivated, whole virus manufacturing platform on which its licensed Japanese Encephalitis vaccine for brain inflammation was developed and produced.
Under the agreement, Emergent will pay Valneva EUR 1 million ($1.2 million) upfront and will get exclusive rights to use Valneva’s intellectual property and know-how related to the Zika product development. The companies are expected to enter into a technology transfer agreement at a later time to enable transfer of Valneva’s technology to Emergent’s Bayview manufacturing facility in Baltimore, Maryland.
The companies plan to initiate the Phase I trial in late 2017 or early 2018 and will share all costs until the availability of Phase 1 data, which is anticipated within six months from trial initiation. Emergent will have the option to continue the development arrangement with Valneva for a milestone payment of EUR 5 million ($5.9 million), upon availability of Phase I data. The agreement also provides Valneva potential additional milestone payments of up to EUR 44 million ($5.2 million) related to product development, approval, commercialization, and product sales, and future royalties on annual net sales.
Emergent has product candidates in various stages of development that target emerging infectious diseases such as Zika, Ebola, dengue, and influenza, including a Zika hyperimmune therapeutic being developed on the company’s hyperimmune platform.