Momenta Drops Biosimilar Adalimumab From Pipeline

August 5, 2019
Kelly Davio

According to Momenta, the decision is a result of “changes in the market opportunity associated with Humira patent litigation settlements.”

Drug maker Momenta said on Friday that it is stopping work on biosimilar M923, a proposed adalimumab biosimilar, and has notified its manufacturing partner that it will not use scheduled manufacturing runs.

According to Momenta, the decision is a result of “changes in the market opportunity associated with Humira patent litigation settlements.”

In an earnings call, Craig Wheeler, president and chief executive officer of Momenta, said, “We have previously said that we would not be taking this program forward ourselves. While we were hopeful that we could secure a commercial partner for this program, and we did have interest as we pursued the path, the market opportunity has changed significantly with recent settlements, ensuring that up to eight players will be launching at once.”

As a result of an inability to secure a commercial partner, said Wheeler, the company believed it was the “prudent” choice to cease investment in the adalimumab program.

The choice to drop the program frees up approximately $100 million in funds to allocate to novel drug programs. The company is now focused on its proposed drug, nipocalimab, an FcRn inhibitor. Momenta says that the product may have superior safety, efficacy, and dosing options versus agents like steroids, immunosuppressants, and intravenous immunoglobulin in treating a variety of diseases, including myasthenia gravis, warm autoimmune hemolytic anemia, and hemolytic disease of fetus and newborn. Other areas of focus for Momenta include a hypersialylated immunoglobulin G antibody and a recombinant Fc multimer.

The decision to cease work on the adalimumab biosimilar means that Momenta has just 1 biosimilar left in its pipeline: a proposed aflibercept biosimilar, referencing Eylea, in development with partner Mylan. Enrollment is ongoing in a phase 3 study of the biosimilar, and Momenta says that the product could launch in the US market as early as 2023.

In 2018, Momenta announced that it was ceasing development of the majority of its biosimilar programs, including an abatacept candidate that failed to meet its primary pharmacokinetic end points in a phase 1 study, and 4 undisclosed biosimilar candidates in preclinical development with partner Mylan.