(Update: details on the marketing authorization applications for the vaccine in the United States and Europe, background, comment from an analyst and Valneva’s stock price)
PARIS (Agefi-Dow Jones)–The biotechnology company Valneva and its partner and American shareholder Pfizer announced Monday evening that they have launched a phase 3 clinical study of their experimental vaccine against Lyme disease, VLA15.
Around 11:00 a.m., Valneva shares rose 1.7% to 10.17 euros, marking one of the strongest increases in the SBF 120 index. “Any positive announcement regarding Valneva’s programs in Lyme disease and chikungunya gives investors the opportunity to put the company’s failure in Covid-19 into perspective and supports its stock price,” said an analyst.
“The randomized, placebo-controlled Phase 3 ‘VALOR’ study is expected to enroll approximately 6,000 participants ages 5 and older,” Valneva and Pfizer said in a statement. Their study will be conducted at up to 50 sites located in regions where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States.
Lyme disease is a systemic infection caused by bacteria transmitted to humans by ticks. Although the true incidence of this disease is unknown, it affects approximately 476,000 people per year in the United States and 130,000 people per year in Europe.
$25 million milestone payment
Under the terms of the collaboration agreement between Pfizer and Valneva, the American pharmaceutical company will pay the French biotech a milestone payment of $25 million at the start of the phase 3 study, or approximately $24.5 million. euros.
VLA15 is currently the only experimental vaccine in clinical trials against Lyme disease. This vaccine has demonstrated strong immunogenicity and an acceptable safety profile in preclinical and clinical studies conducted to date.
Also, the vaccine received “Fast Track” designation from the Food and Drug Administration (FDA), the American health authority, in July 2017. The FDA’s “Fast Track” program is intended to facilitate the development and accelerate reviewing drugs that target serious conditions and have the potential to address an unmet medical need.
“If the Phase 3 study is successfully completed, Pfizer may submit a Biologics License Application, or BLA, to the U.S. Food and Drug Administration (FDA). and a request for marketing authorization (MA) from the European Medicines Agency in 2025”, specified the American group and Valneva.
Valneva will release its first-half results on Thursday. For this period, HC Wainwright forecasts a turnover of 45.3 million euros, down 4.6% over one year, and a net loss of 108.5 million euros. In the first half of last year, the biotech had recorded a net loss of 86.4 million euros.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: LBO
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August 09, 2022 05:09 ET (09:09 GMT)