Even before the diabetes candidate gets regulatory approval, US biotech Provention Bio (Nasdaq: PRVB) revealed it has entered into a co-promotion agreement with French pharma major Sanofi (Euronext: SAN) for the launch of Provention's lead investigational drug candidate teplizumab. Provention’s shares were up almost than 26% at $6.22 by close of trading on Thursday.
The agreement enables Provention Bio to leverage Sanofi's expertise, capabilities and commercial resources to support the potential launch of teplizumab, which is currently under review by the US Food and Drug Administration (FDA), for the delay of clinical type 1 diabetes in at-risk individuals.
The regulator, which delayed making a decision on the drug in July, has set a user fee goal date of November 17, 2022 for the Biologics License Application (BLA). Assuming it gains approval, peak sales of $1.17 billion have been forecast for teplizumab.
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