Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. But as the company works to patch up dosing and manufacturing issues on its lead candidate—dubbed Dasynoc—Xspray has resolved another potential hurdle for its product.

Xspray and BMS have settled patent litigation around Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or earlier under certain undisclosed circumstances, the company said in a press release. The Sprycel patents in question aren’t due to expire until Sept. 28, 2026.

Next, BMS and Xspray will file for dismissal with the United States District Court for the District of New Jersey. The move will eliminate the need for “any additional litigation on this matter,” Xspray said.

BMS, for its part, did not immediately respond to a request for comment.

With the lawsuit out of the way, Xspray is free to “shift its focus towards ensuring a successful product debut in 2024,” Per Andersson, the company’s CEO, said in a statement. “Funds that were previously earmarked for litigation can now be redirected towards advancing Xspray’s future products.”

The settlement comes after Xspray received an FDA rejection on Dasynoc back in July. In rejecting the drug, the FDA requested additional information about the drug’s dosing, plus more clarity around a third-party manufacturing facility.

Xspray is seeking approval for the drug in chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). 

The company is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back in 2010. This past February, Xspray unveiled a commercialization pact with Eversana to support the U.S. launch and sale of Dasynoc.

Sprycel, meanwhile, has continued to rake in blockbuster revenues for BMS. In 2022, the drug brought home full-year sales of $2.16 billion.