Valneva: Emergent BioSolutions and Valneva Initiate Phase 1 Clinical Study to Evaluate Vaccine Candidate Against Zika Virus

Emergent BioSolutions Inc. (NYSE: EBS) and Valneva SE (VLA) today announced the initiation of a Phase 1 clinical trial in the U.S. to evaluate the safety and immunogenicity of VLA1601, their vaccine candidate against Zika virus.

The Phase 1 clinical trial is a randomized, observer-blinded, placebo-controlled, single center study. This study, in approximately 65 healthy adults, will investigate two dose levels of VLA1601 when administered using two different vaccination schedules. Initial data from the trial are expected to be available in late 2018 or early 2019.

Adam Havey, Executive Vice President business operations at Emergent BioSolutions, said, “Emergent’s commitment to our mission –to protect and enhance life– fuels our pursuit for preparedness solutions against Zika virus, the consequences of which remain a public health challenge that requires attention. Our collaboration  with  Valneva on  this  Phase  1  study intends to make meaningful contributions to global research in this field.”

Thomas  Lingelbach, President & CEO of Valneva, added, “We  are  delighted that our collaboration with Emergent has resulted in the clinical progression of a very promising vaccine candidate. This vaccine candidate has already demonstrated an excellent preclinical profile comparable to Valneva’slicensed Japanese Encephalitis vaccine.”

Under the terms of the agreement signed in July 2017, the parties will share all costs until the availability of  Phase 1 data  in  the  U.S. Valneva  will be responsible for the program’s execution until completion of the Phase 1 trial through a joint governance structure.

Upon availability of Phase 1 data, Emergent will have the option  to continue the development and commercialization of a Zika vaccine under its worldwide exclusive license agreement  with Valneva for a milestone payment of €5 million. The agreement provides Valneva  potential  additional  milestone  payments of up to €44 million related to product development, approval, commercialization, and product sales, future royalties on annual net sales, and the right, prior to a Phase 3 clinical trial, to negotiate  with  Emergent exclusive commercialization rights in Europe.

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.

About Zika Virus
The Zika virus (ZIKV) is a mosquito-borne flavivirus that was first discovered in 1947. The first  human  cases  were detected in 1952. Since then, outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and,in 2015, in the Americas.

According to the World Health Organization, there is scientific consensus that ZIKV is a cause of microcephaly and Guillain-Barré syndrome. Since 2013, 31 countries and territories have  reported  cases  of  microcephaly  and  other  central  nervous  system  malformations associated with ZIKV infection.

About VLA1601
VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus,developed using the same manufacturing platform as Valneva’s IXIARO® (JESPECT®) Japanese Encephalitis (“JE”) vaccine. Certain health authorities and key opinion leaders have expressed a preference for the purified inactivated vaccine approach over other vaccine technologies (such  as live-attenuated approaches) since the initial target population for a Zika vaccine is expected to be women of child-bearing age, including those who may be pregnant. There is a theoretical risk that live-attenuated or replication competent viral vaccines given to pregnant women may be capable of crossing the placenta and infecting the fetus. For this reason, live vaccines are not recommended during pregnancy. In pre-clinical development,VLA1601 demonstrated excellent purity and had an overall biological, chemical and physical profile comparable to the commercially produced JE vaccine, which means that a similar safety and immunogenicity profile could be expected. Valneva has an established manufacturing process in its dedicated clinical JE vaccine facility.

About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life  by focusing on providing  specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional  information  about  the  company  may  be  found  at

About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by  ETEC. The Company has proprietary vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at


Lynn Kieffer
Vice President, Corporate Communications
Emergent BioSolutions
Tel: 240-631-3391
E-Mail: KiefferL(at)

Laetitia Bachelot Fontaine
Global Head of Investor Relations &
Corporate Communications
Valneva Investor and Media Contact
Tel: +33 (0)2 2807 1419
Mobile: +33 (0)6 4516 7099
E-Mail: investors(at)

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