Valneva's Chikungunya Vaccine Candidate Awarded EMA Prime Designation
Saint-Herblain (France), October 16, 2020 – Valneva SE (“Valneva” or “the Company”) a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553. This new designation from the EMA complements the Fast Track designation received by the U.S. Food and Drug Administration (FDA) in December 20181.
The PRIME designation is awarded by the EMA to promising medicines that demonstrate the potential to address substantial unmet medical need based on initial clinical data. The EMA considers PRIME designations a priority and provides medicine developers with special support, including enhanced interactions and dialogue, as well as a pathway for accelerated evaluation and review2.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are very pleased to receive PRIME designation for our chikungunya vaccine candidate. It provides further validation of our clinical data and recognition of the significant unmet medical need for chikungunya. We look forward to working closely with the EMA to expedite the availability of our single-shot vaccine to people living in the European Union.”
On September 8, 2020, Valneva announced the initiation of a pivotal Phase 3 clinical trial for VLA15533, becoming the first company worldwide to advance a chikungunya vaccine candidate into Phase 3.
About Phase 3 study VLA1553-301
About Valneva SE
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
4 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 13 Oct 2020.
5 Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg 109:793-802.
7 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020
8 Wressnigg et al. 2020, Lancet ID;20(10):1193-1203.
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