Under the terms of the agreement, Sanofi said it will commence a cash tender offer to acquire all outstanding shares of the US company.

With the buy, Sanofi said it will add an innovative, fully owned, first-in-class therapy in type 1 diabetes to its core asset portfolio in General Medicines and further drive its strategic shift toward products with a differentiated profile.

After long deliberation, Provention Bio’s TZIELD (teplizumab-mzwv) was approved by the FDA last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged eight years and older with Stage 2 T1D.

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.  

Sanofi describes the US company as a strategic fit at the intersection of its own growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need. The new asset’s expertise in diabetes also will be valuable, it noted.

The French drugmaker said it plans to continue utilizing its own capabilities in diabetes to maximize TZIELD’s potential as a transformative therapy globally and in the US work toward the goal of delaying the onset of Stage 3 type 1 diabetes for some of the estimated 65,000 people diagnosed every year.

The two companies have an existing co-promotion agreement for TZIELD Bio under which Sanofi is already delivering the drug to patients in need of the immune-mediated therapy.

Under the terms, Sanofi agreed to pay $35 million to Provention and an additional $20 million to secure the right to first negotiation on exclusive global marketing rights when other governments approve Tzield.

The drug is currently in late-stage clinical development for treatment of pediatric and adolescent patients newly diagnosed with clinical T1D (Stage 3). A Phase 3 trial, PROTECT, is currently under way, and Sanofi said “top line results” are expected in the second half of this year. Additional opportunities for TZIELD include re-dosing and formulations as well as new therapeutic indications, it added.

Author: Dede Williams, Freelance Journalist