In conducting a strategic review of its operations, Momenta Pharmaceuticals has come to a realization: Its challenges in the biosimilar market may be too great to overcome. That was the essence of the announcement of Momenta’s recalibration of its goals and layoff of 50% of its staff.
The company will begin restructuring its executive personnel, replacing its Chief Operating Officer, Chief Scientific Officer, General Counsel and Secretary, Chief Financial Officer, as well as two Senior Vice Presidents. Momenta announced a new Chief Legal Officer, CFO, Chief Business Officer, and Chief Scientific Officer.
Craig Wheeler, CEO of Momenta, stated, “Our goal when we entered this strategic review was to find an effective way to reduce our level of involvement in biosimilar development so that we could refocus our resources on our promising novel drug candidates for immune-mediated diseases.” Mr. Wheeler pointed out, “We explored a number of options, including the sale of all of our biosimilar assets in a single transaction.”
Momenta will continue forward with its two primary biosimilar candidates, M923, an adalimumab biosimilar, and M710, a biosimilar to aflibercept (Eylea®), both of which are in late-stage trials. Its phase 3 trial for aflibercept in patients with diabetic macular degeneration is underway, and not supposed be completed until 2020. In June, Momenta reported that it was ready to send its 351(k) application to the Food and Drug Administration for M923. There is no indication that this occurred, but this delay could have resulted from the strategic review. It had also announced that it is seeking a commercialization partner to compete in the potentially crowded adalimumab market in the US.
Momenta’s biologic portfolio included five other drugs that were part of a partnership with Mylan, and Mr. Wheeler indicated that it is in talks with Mylan about exiting the agreement. Another potential contributing factor in the decision to refocus strategically involved one of its promising biosimilars with Mylan. In November 2017, its abatacept biosimilar (Orencia® is the originator biologic) failed its phase 1 trial.
In its second quarter financial results, Momenta noted its one revenue-generating product, a generic version of Copaxone®, was experiencing declining sales (to less than $12 million in the quarter). Its prospects for selling a generic form of enoxaparin, with Sandoz, evaporated as Sandoz announced that it was no longer producing the injectable agent.
Momenta still has three orphan biologic drugs in its pipeline (to treat immune-related disorders) that have either completed or are in phase 1 development.
Mr. Wheeler noted that focusing on “the advancement of our novel drug pipeline and the continued development of our two late-stage biosimilar programs, M923 and M710, provides us with what we believe to be the best path forward because of the potential for these two biosimilar programs to generate revenues that could help fund our future Phase 3 novel drug clinical trials.”
Although Momenta has not exited the biosimilar space entirely, it is clear that its strategic focus is officially elsewhere. Perhaps this is another buoy warning of rough waters for the biosimilar field.