Stockholm March 18, 2020 - Intervacc AB (publ) announces that the European Medicines Agency, EMA, has today confirmed that the company's application for the granting of a Community marketing authorization for Strangvac is complete and correctly submitted. The regulatory review process for the vaccine against equine strangles, a highly contagious infectious disease now can be initiated.
Today, in accordance with the applicable timetable for the application process, EMA has confirmed that the application for the granting of a Community marketing authorization for Strangvac submitted by Intervacc is validated and ready for review.
The 210-day time frame allocated for the scientific evaluation of the submitted documentation begins on March 19, 2020. In addition, time will be added for answering questions during the review process. The company estimates that the total processing time will be approximately one year.
"It is most gratifying to have this clear sign after the massive effort that has been put into compiling the dossier. We look forward with confidence to the regulatory review process that is now underway, and we are ready to deal with any issues in the near future. We are really happy to be on a historic journey that is now fast approaching the goal of becoming the first Swedish vaccine in animal health approved through the EMA's central procedure" says Tim Wood, VP QA, CMC and Regulatory at Intervacc.
The vaccine has been developed with an innovative technology and is based on fusions of recombinant 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.
The application for the granting of a Community marketing authorization for Strangvac is based on a successful series of clinical studies performed at the Animal Health Trust in the UK demonstrating the safety, immune response, efficacy and DIVA capability. DIVA (Differentiation of Infected from Vaccinated Animals) capability is a key feature during epidemics in order to distinguish vaccinated animals from asymptomatic carriers.
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 March 18, 2020.
Intervacc AB (publ) is a company within the Biotechnology sector. The Company's main area is to develop modern sub-unit vaccines against economically important bacterial infections, within animal health. The company's vaccine candidates are based on several years of 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, firstname.lastname@example.org,+46 (0)8-684 211 10 as Certified Adviser.
Strangvac, a modern vaccine against Equine Strangles, a highly contagious and serious infection 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, as expected of a modern vaccine.
Contact information for Certified Adviser
Eminova Fondkommission AB
E-mail: email@example.com,Phone: +46 (0)8 - 684 211 10
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