Provention Bio Shares Rise 21% After Co-Promotion Agreement With Sanofi U.S.
October 06 2022 - 11:03AM
Dow Jones News
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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