Provention Bio, Inc. and Sanofi collaboration for potential launch of Type I diabetes therapeutic

Provention Bio, Inc. have granted exclusive right of first negotiation to Sanofi in exchange for commercial resources in the United States for the potential approval and launch of monoclonal antibody therapeutic teplizumab.

By granting Sanofi exclusive right of first negotiation for a one-time nonrefundable payment of USD $20 million, Provention will gain access to Sanofi’s expertise, capabilities, and commercial resources leading up to the launch of teplizumab, currently under review by the US FDA. Sanofi pledges to commit its commercial resources in the United States, such as diabetes field specialists and medical science liaisons, to expand Provention’s reach of key healthcare professionals. A right of first negotiation grants Sanofi exclusive global rights for the commercialisation of teplizumab for indications in humans. While Provention may engage in certain discussions with third parties with respect to transactions, Sanofi can exercise this right until June 30 2023, with the collaboration open to extension under certain conditions. The two companies also entered into a Securities Purchase Agreement in which, should teplizumab gain US FDA approval, Sanofi will purchase USD $35 million of Provention’s common stock at a premium.  

Teplizumab, the mAb in question, has been developed to delay clinical Type I diabetes in at-risk individuals. These individuals are determined by the presence of two or more Type I diabetes-related autoantibodies. Currently, there has been no disease-modifying therapeutic for diabetes since the advent of insulin in the 20th century. In multiple clinical studies, more than 800 patients have received a treatment of teplizumab. The drug is currently being evaluated in patients newly diagnosed with insulin-dependent Type I diabetes. 

Co-Founder and CEO of Provention Bio Ashleigh Palmer commented: “The agreement brings significant resources to Provention and allows us to advance our mission of delivering therapies which intercept or delay debilitating and life-threatening autoimmune diseases... We look forward to working with our colleagues at Sanofi as we prepare to deliver, if approved, the first-ever disease-modifying therapy for [Type I diabetes].” 

Sanofi’s Head of US General Medicines Olivier Bogillot echoed similar sentiments. “We are delighted by the prospect of supporting Provention Bio in bringing to the US what could become the first-in-class therapy to change the course of Type I diabetes,” he stated. “If approved, Sanofi U.S. will leverage its existing world-class capabilities in diabetes care to enhance efforts in both patient and healthcare provider access. We are prepared to tap into all of our internal expertise to support the successful launch of this innovative therapy.” 

Source: Provention Bio to Combine Forces with Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals - Oct 6, 2022