On October 6, 2022 Sanofi US reported it has entered into a co-promotion service agreement with Provention Bio, Inc., for the commercialization of teplizumab in the United States (Press release, Sanofi, OCT 6, 2022, View Source [SID1234621812]). Teplizumab, developed by Provention, is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, as indicated by the presence of two or more T1D-related autoantibodies. If approved by the U.S. Food and Drug Administration (FDA), teplizumab would be the first-ever disease-modifying therapy in T1D.

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Pending FDA approval, Sanofi US will co-promote teplizumab along with its existing portfolio of diabetes therapies, and leverage its customer-facing field teams with the aim of accelerating uptake of teplizumab across the U.S.

Olivier Bogillot
Head of U.S. General Medicines, Sanofi
"We are delighted by the prospect of supporting Provention Bio in bringing to the U.S. what could become the first-in-class therapy to change the course of type 1 diabetes. If approved, Sanofi US will leverage our 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."

Jason Hoitt
Chief Commercial Officer, Provention Bio
"Teplizumab represents a potentially disruptive new therapy for T1D, and we are excited to work alongside Sanofi US to bring the first-ever disease-modifying therapy, if approved, to individuals in the U.S. who are at risk of developing clinical-stage type 1 diabetes."

The FDA is expected to make a decision on the regulatory approval for teplizumab on November 17, 2022.

Agreement Terms
Dependent on a positive decision from the FDA, Provention Bio will contract Sanofi US customer-facing field teams. Provention Bio retains all rights to teplizumab, responsible for key activities such as R&D, pharmacovigilance, production, quality and safety.

As of the effective date of the service agreement, Sanofi US has committed to make an upfront payment of $20 million to Provention Bio. In connection with this transaction, Provention Bio has granted Sanofi US an exclusive right of first negotiation for a potential in-license agreement of teplizumab in T1D.

Sanofi US also has agreed to make an equity investment of $35 million in Provention Bio, within a defined period after FDA approval of teplizumab, should this take place.

About type 1 diabetes
Type 1 diabetes is a condition caused by autoimmune damage of the insulin-producing beta-cells of the pancreas. As a result of this autoimmune attack, the body produces very little or no insulin which can lead to death if the insulin is not replaced.

Living with T1D is complex. In addition to daily insulin injections or infusion via an insulin pump, people living with T1D also need to adopt a strict management plan which includes regular blood sugar monitoring, healthy diet and physical activity.