Autoimmune Pipelines Drive Acquisitions by Sanofi and Johnson & Johnson

Sanofi and Johnson & Johnson (J&J) are making moves to expand their autoimmune portfolios with recently announced acquisitions.

The week kicked off with Sanofi announcing it will acquire Principia Biopharm, a late-stage company focused on developing treatments for immune-mediated diseases. A few days later, J&J announced it is acquiring Momenta Pharmaceuticals, a biotechnology company focused on novel biologic therapeutics to treat rare immune-mediated diseases.

Sanofi will purchase Principia for approximately $3.68 billion, and in the announcement, the company highlighted adding Principia’s Bruton tyrosine kinase (BTK) inhibitors to its portfolio. Principia has a BTK inhibitor being studied in multiple sclerosis in a phase 2b trial, as well as a BTK inhibitor topic agent in phase 1 trials and an oral BTK inhibitor being evaluated in a phase 3 program to treat moderate to severe pehmphigus, a rare, debilitating autoimmune disease that causes blistering of the skin and mucous membranes.

“This acquisition advances our ongoing R&D transformation to accelerate development of the most promising medicines that will address significant patient needs,” Paul Hudson, Sanofi CEO, said in a statement. “The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas.

J&J will purchase Momenta for approximately $6.5 billion in cash. The transaction is expected to close in the second half of 2020. Until the completion of the transaction, Momenta will continue to operate as a separate and independent company.

“This acquisition broadens Janssen’s leadership in autoimmune diseases and provides us with a major catalyst for sustained growth," Jennifer Taubert, executive vice president, worldwide chairman, pharmaceuticals, J&J, said in a statement. “Autoantibody-driven diseases are often serious, and patients are underserved by current treatment options.”

According to J&J’s announcement, the acquisition was driven by the opportunity seen in nipocalimab, an anti-FcRn antibody designed to target a number of autoantibody-driven conditions. It is being tested for a variety of diseases, including myasthenia gravis, a neuromuscular disease that causes weakness in muscles.

"The agreement with J&J recognizes the value created by years of commitment and dedication to our mission by the many current and past Momenta employees,” Craig Wheeler, president and CEO of Momenta, said in a statement. “Programs such as nipocalimab have the potential to improve the lives of countless patients suffering from autoimmune and fetal maternal diseases.”

In June 2020, Momenta announced positive topline data from an interim analysis of a phase 2 study of nipocalimab in generalized myasthenia gravis. The analysis showed that the treatment induced a rapid and durable response in the myasthenia gravis activities of daily living score, and it met the primary end point of a linear and highly statistically significant relationship between reduction of immunoglobulin G and the daily living score benefit.

Full results from the trial are expected in the fourth quarter of 2020. Momenta has also received a rare pediatric disease designation by the FDA for nipocalimab in hemolytic disease of the fetus and newborn.

J&J currently has 5 approved therapies in to treat more than 30 pediatric and adult indications in autoimmune diseases. However, there remains a significant unmet need in autoimmune diseases and only a small fraction of patients living with autoimmune disease achieve sustained clinical remission, according to J&J.

“Combining Momenta’s discoveries with our 20-year heritage in immunology, global scope, and scientific and medical expertise, we see a real opportunity to create an entire ‘pipeline in a pathway,’” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development, J&J. “We are excited about the significant potential to expand on Momenta’s excellent progress in rare diseases, and to increase our impact on patients both within and beyond our current focus areas.”