Xspray Pharma settles with BMS over Sprycel generic, awaits FDA nod

Xspray Pharma, Sprycel, patent, lawsuit, Sprycel generic, chronic myeloid leukemia, acute lymphatic leukemia, Bristol Myers Squibb

Xspray Pharma, which encountered an FDA setback in July, was initially aiming to launch its competitor to Bristol Myers Squibb’s leukemia drug Sprycel in the second half of 2023. However, as the company addresses dosing and manufacturing issues with its lead candidate, Dasynoc, it has now reached a patent litigation settlement with BMS, clearing the way for a potential Dasynoc launch on or before September 1, 2024. This settlement resolves all pending claims and pertains to patents for Sprycel, which aren’t set to expire until September 28, 2026.

Both Xspray and BMS will request a dismissal from the United States District Court for the District of New Jersey, eliminating the need for further litigation in this matter. 

 “This settlement provides clarity on the launch date of our leading product, Dasynoc™, benefiting the market. It also allows Xspray to shift its focus towards ensuring a successful product debut in 2024. Funds that were previously earmarked for litigation can now be redirected towards advancing Xspray’s future products.” 

– Andersson, CEO Xspray Pharma.

Bristol Myers Squibb has not provided an immediate response to this settlement. Despite the FDA’s rejection of Dasynoc in July, which prompted requests for additional information on dosing and manufacturing facilities, Xspray is seeking approval for the drug in treating chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL).

Xspray Pharma positioned Dasynoc as a competitor to BMS’ Sprycel, which received its first approval for CML in 2010. Earlier this year, Xspray entered a commercialization agreement with Eversana to support the launch and sales of Dasynoc in the United States. Meanwhile, Sprycel continues to generate substantial revenues for Bristol Myers Squibb, with full-year sales reaching $2.16 billion in 2022.

In summary, Xspray Pharma has settled patent litigation with Bristol Myers Squibb, potentially paving the way for the launch of its leukemia drug Dasynoc in 2024. This settlement allows Xspray to redirect resources toward product development and positions Dasynoc as a rival to the successful Sprycel, which remains a blockbuster for BMS in the treatment of leukemia.

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