On October 6, Provention announced an agreement with Sanofi to jointly advance the commercialization of teplizumab. Previously, the FDA has accepted a Biologics License Application (BLA) for teplizumab to delay type 1 diabetes in high-risk groups and set the PDUFA date of November 17, 2022.
Teplizumab is a humanized anti-CD3 monoclonal antibody originally developed by MacroGenics. In October 2007, Eli Lilly acquired global development and commercialization rights to teplizumab for an upfront payment of $41 million, but the agreement was terminated in October 2010. In May 2018, Provention acquired all interests in teplizumab and another investigational new drug, PRV-3279, from MacroGenics.
In April 2020, Provention began a rolling BLA submission for teplizumab, but received a full response letter (CRL) from the FDA in July 2021. In February of this year, Provention refiled the BLA. Currently, a Phase III PROTECT study of teplizumab for the delay of type 1 diabetes in patients aged 8-17 years is ongoing.
Under the terms of the agreement, Sanofi will commit commercial resources in the United States, including diabetes field experts, account directors, base reimbursement and medical science liaisons, to expand the number of key healthcare professionals responsible for the United States.
In addition, Sanofi is required to pay $20 million for an exclusive one-time right of first negotiation (ROFN) for exclusive global commercialization rights to teplizumab for the human type 1 diabetes indication. Sanofi can exercise ROFN until June 30, 2023, or until the end of 2023 (subject to certain conditions).
In addition to the promotion agreement, Proventon and Sanofi have entered into a securities purchase agreement. Under the terms of the purchase agreement, if teplizumab is approved by the FDA, Sanofi will invest $35 million in Proventon’s common stock at a price per share at a daily volume higher than the price per share for five consecutive trading days prior to the trading day Weighted average. The closing date for trading will be at Proventon’s sole discretion, but not later than February 16, 2023.