Sanofi to acquire first disease-modifying treatment for the delay of stage 3 type 1 diabetes

Sanofi has agreed to acquire Provention Bio, Inc., 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 US last year as the first and only therapy to delay the onset of stage 3 type 1 diabetes in adults and children aged eight years and older with stage 2 type 1 diabetes.

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 utilise its capabilities in diabetes to maximize TZIELD’s potential as a transformative therapy globally and in the US, 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 people in need of this immune-mediated therapy.

Olivier Charmeil, Executive Vice President, General Medicines, Sanofi, said: “The acquisition of Provention Bio builds on Sanofi’s mission to deliver best – and first-in-class medicines and resonates with our purpose of chasing the miracles of sciences for the benefit of people.

“By coupling Provention Bio’s transformative innovation with Sanofi’s expertise, we aim to bring life-changing benefits to people at risk of developing stage 3 type 1 diabetes.”

He added: “Any additional indications, approvals and pipeline assets only serve to further our excitement.

“Given our existing partnership and complementary work in the diabetes and immunology spaces, we foresee a seamless integration and execution.”

TZIELD is a CD3-directed antibody indicated to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years and older with stage 2 type 1 diabetes.

Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and people who progress to stage 3 type 1 diabetes eventually require insulin injections for life.

TZIELD is also in late-stage clinical development for the treatment of children and teenagers that are newly diagnosed with clinical type 1 diabetes (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.

Ashleigh Palmer, Chief Executive Officer and Co-Founder, Provention Bio, Inc., noted: “Sanofi and Provention Bio share a common vision of bringing new therapies to people with autoimmune diseases.

“Under our co-promotion agreement, our companies have made significant progress educating healthcare providers and increasing patient access during the initial US commercial launch of TZIELD.”

She added: “Sanofi’s global expertise and commitment to immunology makes them an ideal acquiror and positions our innovative therapy to reach more people as quickly as possible.”

Provention Bio also brings certain pipeline assets in early development in immune-mediated diseases.

Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Provention Bio, Inc. for $25.00 per share in cash, reflecting a total equity value of approximately $2.9 billion.

The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Provention Bio, Inc. common stock, that together with shares already owned by Sanofi or its affiliates, represents at least a majority of the outstanding shares of Provention Bio, Inc. common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Provention Bio, Inc., and all of the outstanding Provention Bio, Inc. shares that are not tendered in the tender offer will be converted into the right to receive the same $25.00 per share in cash offered to Provention Bio, Inc. shareholders in the tender offer.

Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi currently expects to complete the acquisition in the second quarter of 2023.

PJT Partners is acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is acting as its legal counsel.

BofA Securities, Inc. and Centerview Partners LLC are acting as financial advisors to Provention Bio, Inc. and Ropes & Gray LLP is acting as its legal counsel.

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