Provention Bio had already received a $35m equity investment from Sanofi (closed in February), while the two companies are partnering on the US commercial launch of Tzield.
Announcing the acquisition this morning, Sanofi says the deal represents a ‘strategic fit 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’.
First focus: growing Tzield
Tzield was approved by the FDA in adults and pediatric patients aged 8 years and older with Stage 2 Type 1 diabetes in November, with the American Diabetes Association hailing the decision as a ‘historic moment’.
T1D usually develops in children or young adults; although can happen at any age. It is less common than type 2 diabetes (around 5-10% of people with diabetes have T1D) and is thought to be caused by an autoimmune reaction. Diet and lifestyle habits don’t cause T1D.
T1D typically takes more than a decade off a person's life.
T1D starts in the body long before symptoms appear: but those with pre-symptomatic Stage 2 T1D have a nearly 100% risk of going on to develop symptomatic diabetes (a blood test can detest Stage 2 T1D).
Tzield (teplizumab-mzwv) is a CD3-directed antibody for patients with Stage 2 T1D: which binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. The drug may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
A clinical trial in pre-symptomatic Stage 2 type 1 diabetes (T1D) patients showed that Tzield delayed the median onset of symptomatic Stage 3 T1D by around two years – consequently delaying the burdens, complications and risks associated with Stage 3 T1D: such as life-long insulin injections.
Sanofi says it will continue to use its capabilities in diabetes to maximize Tziel’s potential: aiming to delay the onset of Stage 3 type 1 diabetes for some of the approximately 65,000 people diagnosed every year.
Olivier Charmeil, Executive Vice President, General Medicines at 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 science 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.
"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 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.
Sanofi also eyes up additional opportunities for Tzield which include re-dosing and formulations as well as new therapeutic indications.
Potential of immune-mediated disease pipeline
Founded in 2017, New Jersey’s Provention Bio is focused on the development of immune-mediated diseases: highlighting a clear and differentiated focus on early interception before symptoms present and irreversible damage is done to the bodies. It estimates that more than 23 million patients live with autoimmune disease in the US alone.
Its aim is to advance clinical programs and platform assets focused on the core tenets of autoimmunity (T-cells, B-cells and innate immunity).
Past Tzield, its pipeline includes clinical-stage product candidates for celiac disease and lupus.
Ashleigh Palmer, Chief Executive Officer and Co-Founder, Provention Bio, said: “Sanofi and Provention Bio share a common vision of bringing new therapies to patients 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. Sanofi’s global expertise and commitment to immunology makes them an ideal acquiror and positions our innovative therapy to reach more patients as quickly as possible.”
Sanofi will pay $25.00 per share in cash, representing an equity value of Provention Bio around $2.9bn.