Emergent Biosolutions said on Wednesday it has entered into a licensing agreement with Valneva SE for the global exclusive rights to the company’s Zika vaccine technology, ZIKV.
“Emergent is focused on providing preparedness solutions to public health threats and emerging infectious diseases,” Adam Havey, Emergent’s EVP of Business Operations, said. “This commitment extends beyond acquiring revenue-generating products and advancing our own products to aligning with partners such as Valneva to develop innovative products that could potentially serve the needs of both government customers and the commercial market.”
The two companies will also co-develop ZIKV-VLA1601, a highly-purified inactivated vaccine candidate for preclinical development through the completion of a Phase 1 safety and immunogenicity clinical trial. ZIKV-VLA1601 has shown to elicit strong antibody responses and is based on Valneva’s established inactivated, whole virus manufacturing platform which the company has used in the past to develop and produce a vaccine for Japanese encephalitis.
Emergent said it expects to enter into an agreement with Valneva on a future date still to be determined to allow for the transfer of Valneva’s technology to Emergent’s Bayview, Maryland-based manufacturing facility.
Zika virus is a member of the flavivirus family of viruses along with chikungunya, dengue fever, yellow fever, and Japanese encephalitis. It is typically spread through the bite of Aedes aegypti-species mosquito and sexual contact. Symptoms of infection include fever, rash, headache and lethargy. More seriously, the virus has been linked to malformations in the fetus of pregnant women and Guillain-Barré syndrome.
Under terms of the agreement, Emergent will pay Lyon, France-based Valneva $1.16 million (1 million euros) upfront and will receive exclusive rights to use Valneva’s intellectual property related to Zika-related product development. The two companies then plan to initiate a Phase 1 trial in late 2017 or early 2018 and will share all costs until the availability of Phase 1 data.
Emergent will then have the option to continue the development arrangement with Valneva for a milestone payment valued at $5.8 million (5 million euros). In addition, the agreement provides additional milestone payments of up to $51.4 million (44 million euros) related to product development, approval, commercialization, product sales, and future royalties on annual net product sales.
The Gaithersburg, Maryland-based Emergent said it already has product candidates in various stages of development that target infectious diseases including Zika, Ebola, dengue, and influenza.