By Chris Wack

Provention Bio Inc. shares were up 21% to $6 after the company said it has entered into a co-promotion agreement with Sanofi U.S. for the launch of Provention's lead investigational drug candidate teplizumab.

The agreement enables Provention Bio to use Sanofi's expertise, capabilities and commercial resources to support the potential launch of teplizumab currently under review by the U.S. Food and Drug Administration, for the delay of clinical type 1 diabetes in at-risk individuals.

The company sees a user fee goal date of Nov. 17 for the Biologics License Application.

Under the terms of the agreement, Sanofi will commit commercial resources in the U.S, including diabetes field specialists, account directors, field-based reimbursement and medical science liaisons to expand the number of key healthcare professionals reached in the U.S. In exchange, Provention will reimburse field force-related expenses that Sanofi will incur in connection with commercializing teplizumab under the agreement.

Provention retains all rights to teplizumab and maintains responsibility for the commercialization strategy.

The company also granted Sanofi, in consideration of a one-time payment of $20 million, an exclusive, one-time right of first negotiation to obtain exclusive global rights to commercialize teplizumab for Type 1 diabetes indications in humans. Sanofi may exercise the ROFN, until June 30, 2023, with an option to extend within 2023 under certain conditions.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 06, 2022 10:48 ET (14:48 GMT)

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