Intervacc Announces Submission of Responses to EMA Day 120 Questions
Stockholm, January 12, 2021 – Intervacc AB (publ) announces that the responses to the Day 120 questions regarding the Company’s Marketing Authorization Application (MAA) for Strangvac® has been submitted today to the European Medicines Agency (EMA). Intervacc is seeking approval for Strangvac® as a vaccine against equine strangles, a highly contagious infectious disease that affects horses globally.
After validating the submission and reviewing the responses, a second list of questions and outstanding issues is expected from the Committee for Medicinal Products for Veterinary Use (CVMP). The Company estimates that it is on track for a positive opinion from the CVMP during Q2 2021.
The vaccine has been developed with an innovative technology and is based on recombinant fusion proteins. The research behind the vaccine’s technical platform has been done together with researchers at Karolinska Institute and the Swedish University of Agricultural Sciences, SLU.
“Upon approval, Strangvac® will be the first Swedish Animal Health Vaccine to receive marketing authorization by the centralised EMA procedure covering all 27 member states of the European Union (E.U.), as well as Iceland, Liechtenstein and Norway. The UK has also decided to follow the EMA approval up until at least first of January 2023.”, stated Dr Andrew Waller, Chief Scientific Officer at Intervacc.
The MAA for Strangvac® is based on a successful series of clinical studies demonstrating the safety, immunogenicity, efficacy and DIVA capability of this exciting vaccine. DIVA (Differentiation of Infected from Vaccinated Animals) capability is a key feature for prevalent endemic diseases such as equine strangles in order to distinguish vaccinated animals from those that have been exposed to the bacteria Streptococcus equi.
For more information please contact:
Andreas Andersson, CEO
Phone: +46 (0)8 120 10 601, Cell: +46 (0)73 335 99 70
This information is information that Intervacc AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on January 12, 2021.
Intervacc AB is a Swedish company within animal health developing safe, effective vaccines for animals. The Company’s vaccine candidates are based on research at Karolinska Institutet and Swedish University of Agricultural Research where the foundation was laid for the Company´s research and development work. The Intervacc share has been listed on the Nasdaq First North Growth Market since April 2017 with Eminova Fondkommission AB, email@example.com, +46 (0)8–684 211 10 as Certified Adviser.
Strangvac®, a modern vaccine against Strangles, a highly contagious and serious infection in horses caused by the bacterium Streptococcus equi. Strangvac® consists of only soluble recombinant proteins, is injected intramuscularly and totally devoid of any living infectious agent. This results in a well-tolerated vaccine with excellent safety profile.
Contact information for Certified Adviser
Eminova Fondkommission AB
E-mail: firstname.lastname@example.org, Phone: +46 (0)8 – 684 211 10