NEW YORK – Lantheus and Point Biopharma announced on Monday that they've entered a licensing agreement for two of Point's radiopharmaceutical product candidates.
Under the terms of the agreement, Lantheus will pay Point Biopharma $260 million upfront for exclusive worldwide rights to two therapies: PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical for metastatic castration-resistant prostate cancer, and PNT2003, a somatostatin receptor (SSTR)-targeted radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors. Both therapies are undergoing Phase III clinical trials.
Point Biopharma may be eligible for an additional $1.8 billion in milestone payments contingent on regulatory approvals, net sales, and achievement of other commercial milestones. Should the therapies be commercialized, Point Biopharma can also receive 20 percent royalties on net sales for PNT2002, and 15 percent royalties on net sales of PNT2003.
For PNT2002, the terms of the agreement stipulate that Point will fund and complete the ongoing Phase III SPLASH clinical trial, after which Lantheus and Point will jointly file a new drug application to the US Food and Drug Administration. For PNT2003, meanwhile, Point will help complete the ongoing Phase III OZM-067 study, which is sponsored by the University Health Network in Canada. Lantheus will then submit regulatory findings to the FDA.
Lantheus and Point Biopharma plan to create steering committees so they can jointly oversee additional clinical studies, regulatory applications, and manufacturing and commercial preparation for both agents. The licensing territory excludes Japan, South Korea, China, Singapore, and Indonesia, where Point Biopharma retains the rights to PNT2002 and PNT2003.
"This collaboration … immediately unlocks value for Point, reduces the need for dilutive fundraising, and enables us to focus on our pipeline of next-generation radioligands, which could be transformative for the field of precision oncology," Point Biopharma CEO Joe McCann said in a statement. He added that the firm plans to continue developing additional radiopharmaceuticals, including PNT2004, which is in Phase I trials in multiple cancer types, and PNT2001, which is expected to enter Phase I trials next year.