Momenta Pharmaceuticals announced that after a strategic review of its operations, the company will refocus on novel therapeutics rather than on biosimilars.
Yesterday, Momenta Pharmaceuticals announced that after a strategic review of its operations, the company will refocus on novel therapeutics rather than on biosimilars.
Momenta says that its 5-year restructuring plan, which involves layoffs of 50% of its staff—or 110 workers—will produce approximately $250 million in savings, but it adds that it will need to conduct additional fundraising activities in the coming years.
Momenta noted that it will continue to develop 2 of its late-stage biosimilars: M923, Momenta’s wholly owned proposed adalimumab biosimilar referencing Humira, and M710, a proposed aflibercept biosimilar referencing Eylea.
The aflibercept candidate is being developed in conjunction with Mylan, and the partnership had announced in January 2018 that it would enter a pivotal clinical trial of the drug in patients with diabetic macular edema.
Mylan also partnered with Momenta on 5 additional biosimilar products, including an abatacept (Orencia) candidate for which the companies have completed a phase 1 study that failed to meet its primary pharmacokinetic end points, and 4 undisclosed biosimilar candidates in preclinical development. Momenta indicated that it is discussing the future of these products with Mylan.
When Mylan and Momenta first announced their partnership in early 2017, the deal was expected to generate up to $245 million for Momenta, based on milestone payments tied to achievements. At the time, the companies expected to submit the adalimumab product for regulatory approval in 2017, with a commercial launch planned for 2018.
Momenta’s unreached biosimilar goals and its subsequent change of course raise questions about the sustainability of biosimilar development for smaller companies. With high development costs, an uncertain patent landscape, and sluggish biosimilar uptake in the United States, it remains to be seen whether smaller ventures, even in partnership with more established companies, will be able to make their biosimilar efforts financially feasible.