The buyout will give Sanofi rights over Tzield (teplizumab-mzwv), Provention’s diabetes delay drug. The FDA approved Tzield in November 2022 to slow the onset of stage 3 Type 1 diabetes (T1D), making it the first-ever disease-modifying treatment to delay disease progression.
Tzield is indicated for adult patients and children 8 years and older.
Provention’s stock soared 262% in premarket trading Monday. Sanofi shares were minimally affected, with the French company trading 0.30% higher premarket.
“We believe the commercial opportunity of TZIELD, in [the] delay onset indication is on its own a meaningful opportunity,” Olivier Charmeil, executive vice president, General Medicines, Sanofi, told BioSpace in an email.
The companies expect to close the buyout in the second quarter of 2023, after which a Sanofi subsidiary will merge with Provention. Sanofi plans to fund the acquisition with cash resources.
Sanofi and Provention already have an existing partnership for Tzield. In October, a month before the FDA’s approval, the companies inked a co-promotion deal to support the product’s launch. The agreement gave Sanofi an “exclusive right of first negotiation” to potentially in-license Tzield worldwide, a company spokesperson told BioSpace at the time.
Tzield is a monoclonal antibody that targets the CD3 protein, which is found on the surface of the specific T-cell subsets involved in destroying pancreatic β cells, a pathologic hallmark of T1D. Tzield’s approval was based on the TN-10 study, which showed the medicine reduced the risk of progression to stage 3 disease by nearly 60%.
Provention is currently running the Phase III PROTECT trial, testing Tzield in kids and teens with newly diagnosed T1D. Data from this study are expected in the second half of 2023.
For Sanofi, Monday’s acquisition of Provention sits “right at the intersection between our expertise in diabetes and growth in immune-mediated diseases and disease modifying therapies in areas of high unmet need,” Charmeil said.
Sanofi owns diabetes drugs Lantus (insulin glargine) and Toujeo (insulin glargine), which in 2022 made the company around $2.4 billion and $1.2 billion, respectively. In 2019, however, the company announced it was abandoning research in this therapeutic space in favor of hotter areas like cancer, rare diseases and neurology.
Recent pressure from U.S. lawmakers could put a dent in Sanofi’s diabetes drug revenues. The Provention acquisition might help Sanofi prepare for the impending drop in insulin prices and remain an industry leader in diabetes.
The buyout will also involve Provention’s assets in development, which are focused on autoimmune pathways. These include PRV-3279, which is being trialed for systemic lupus erythematosus and for the prevention of immunogenicity in gene therapies, as well as ordesekimab, being assessed for celiac disease.
By Tristan Manalac – BioSpace