Provention: Prepping for Launch of Teplizumab Ahead of Nov 17th FDA User Fee Goal Date

 Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.

"Throughout the third quarter, we have continued to interact with the FDA in support of our resubmitted, breakthrough therapy designated, teplizumab BLA for the delay of clinical type 1 diabetes in at-risk individuals," stated Ashleigh Palmer, Chief Executive Officer & Co-Founder, Provention Bio. "As we approach our upcoming November 17th FDA action date, we are pleased to report that we have received both the FDA's proposed labelling and post-marketing requirements and commitments, and that these are generally consistent with our expectations. In parallel, we have been advancing our planning and preparations for the potential commercial launch of teplizumab and our recently announced co-promotion agreement, which allows us to leverage the expertise, capabilities, and commercial resources of Sanofi. Finally, we were able to strengthen our balance sheet by raising additional capital during the third quarter."

Third Quarter 2022 and Recent Corporate Highlights:

Entered into Agreement with Sanofi to Support Potential U.S. Launch of Teplizumab

On October 6, 2022, the Company announced that it entered a co-promotion agreement with Sanofi U.S. for the potential launch of Provention's lead investigational drug candidate, teplizumab. Teplizumab is currently under review by the U.S. Food and Drug Administration (FDA), for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, with a user fee goal date of November 17, 2022.

The Company also granted Sanofi, in consideration of a non-refundable, one-time payment of $20.0 million, an exclusive, one-time right of first negotiation (ROFN) to obtain exclusive global rights to commercialize teplizumab for T1D in humans, subject to certain retained rights of the Company to engage in discussions with third parties with respect to certain transactions. Sanofi may exercise the ROFN until June 30, 2023, with an option to extend within 2023 under certain conditions. The Company received the $20.0 million payment in October from Sanofi.

Simultaneously with their entry into the co-promotion agreement, the Company and Sanofi entered into a Securities Purchase Agreement (the Purchase Agreement). Pursuant to the Purchase Agreement, if teplizumab is approved by the FDA, Sanofi has agreed to purchase $35.0 million of the Company's common stock at a premium over the daily volume-weighted average per share price for the five consecutive trading days prior to the closing date. The closing date will be at Provention's discretion and would occur no later than February 16, 2023.

https://finance.yahoo.com/news/provention-bio-reports-third-quarter-110000689.html