Sanofi to Acquire Provention Bio

The transaction will add Tzield, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes, to Sanofi’s portfolio.

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The following is an abbreviated version of the original press release.

Sanofi and Provention Bio have entered into an agreement under which Sanofi has agreed to acquire Provention Bio for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.

The transaction adds an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofi’s core asset portfolio in general medicines and further drives its strategic shift toward products with a differentiated profile. Tzield (teplizumab-mzwv) was approved in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need, and its expertise in diabetes. Sanofi will continue to utilize its capabilities in diabetes to maximize Tzield’s potential as a transformative therapy globally and in the U.S., aiming to delay the onset of Stage 3 type 1 diabetes for some of the approximately 65,000 people diagnosed every year. The purchase builds on an existing co-promotion agreement with Provention Bio that is already delivering Tzield to patients in need of this immune-mediated therapy.

Tzield is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and patients who progress to Stage 3 T1D eventually require insulin injections for life.

Tzield is also in late-stage clinical development for the treatment of pediatric and adolescent patients that are newly diagnosed with clinical T1D (Stage 3). A Phase 3 trial, PROTECT, is currently underway and top line results are expected in the second half of 2023. Additional opportunities for Tzield include re-dosing and formulations as well as new therapeutic indications.

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