French pharmaceutical firm Sanofi has agreed to acquire Principia Biopharma, a late-stage biopharmaceutical company, for a total value of around $3.68bn.

Under the terms of the agreement, Sanofi will acquire all of the outstanding shares of Principia, at a price of $100 per share, on a fully diluted basis.

Principia Biopharma is engaged in developing transformative therapies that address unmet medical needs in immune-mediated diseases.

Sanofi chief executive officer Paul Hudson said: “This acquisition advances our ongoing R&D transformation to accelerate development of the most promising medicines that will address significant patient needs.

“The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas. Full ownership of our brain-penetrant BTK inhibitor ‘168 removes complexities for this priority development program and simplifies future commercialisation.”

Principia Biopharma’s BTK inhibitor ‘168, Rilzabrutinib, PRN473 will benefit Sanofi

With the transaction, Sanofi will benefit from Principia’s Bruton tyrosine kinase (BTK) inhibitors, and create a portfolio of next generation transformative therapies for autoimmune diseases.

BTK is claimed to play a crucial role in the immune system by blocking the signaling pathways of innate and adaptive cells, thereby preventing the inflammation and tissue damage associated with autoimmune diseases.

Principia’s BTK inhibitor ‘168 has reduced Gd-enhancing T1 hyperintense lesions in 85% of patients with multiple sclerosis compared to placebo, in a Phase 2b clinical trial.

The transaction is expected to enable Sanofi to expand its development programme to evaluate indications beyond central nervous system diseases.

Rilzabrutinib is an oral BTK inhibitor currently being studied in a Phase 3 programme to treat patients with pemphigus, a rare autoimmune disease causing blistering of the skin and mucous membranes.

A Phase 3 programme is expected to be commenced by the end of 2020 to evaluate Rilzabrutinib for immune thrombocytopenia, a disease that causes high risk for bleeding events.

Also, a Phase 2 program is underway for IgG4-related diseases, characterised by chronic inflammation, immune cell infiltration, and fibrosis within organs that can lead to severe morbidity.

PRN473 Topical is a topical agent currently being studied under Phase 1 trial and is being developed for immune-mediated diseases for localised application to the skin.

For the transaction, Evercore served as financial advisor and Weil, Gotshal & Manges as legal counsel to Sanofi, while Centerview Partners and BofA Securities served as financial advisors and Cooley as legal counsel to Principia.

Principia Biopharma president and CEO Martin Babler said: “Principia’s successful design and development of a whole portfolio of BTK inhibitors for immunology is aimed to transform the treatment for patients with immune-mediated diseases. By combining with Sanofi, we will bring significant resources to expand and accelerate the potential benefits of these therapies.

“The benefit of developing several BTK inhibitors will allow us to target specific organ systems for optimal patient benefit. The merger will provide global resources to get these novel therapies to patients faster.”