Lantheus Holdings, Inc. and POINT Biopharma Global Inc. announced a set of strategic collaboration agreements in which Lantheus will license exclusive worldwide rights to POINT's PNT2002 and PNT2003 product candidates. Upon consummation of the agreements, in exchange for the exclusive worldwide rights, Lantheus will pay a total of $260 million in upfront payments between the two agreements to POINT, with the potential for additional milestone payments of approximately $1.8 billion between the two products based on U.S. Food and Drug Administration (FDA) approval and net sales and commercial milestones. Additionally, Lantheus will pay POINT royalties on net sales, beyond certain financial thresholds and subject to conditions, of 20% for PNT2002 and 15% for PNT2003.
The agreements expand Lantheus' radiopharmaceutical portfolio with two late-stage therapeutic candidates and, with PNT2002, broadens Lantheus' prostate cancer franchise. For POINT, the agreement pairs PNT2002 and PNT2003 with an ideal commercialization partner, and offsets launch and marketing risks, while still maintaining the value and independence of POINT's next generation radioligand platform. Lantheus expects the agreements to drive long-term, sustainable revenue and free cash flow growth and be accretive to its Adjusted Earnings Per Share (Adjusted EPS) shortly following commercialization of PNT2002.
Under the agreements, POINT will fund and complete its Phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application (NDA) in collaboration with POINT. For PNT2003, POINT will facilitate completion of the ongoing University Health Network (UHN)-sponsored ongoing OZM-067 study in Canada, while Lantheus will prepare and submit the regulatory filings in the U.S. Upon consummation of the agreements, the companies will form joint steering committees to oversee the clinical studies, regulatory filings, manufacturing and commercial readiness for both PNT2002 and PNT2003. POINT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003.
Lantheus has the rights to commercialize both assets post regulatory approval. The collaboration diversifies Lantheus' portfolio with two radiotherapeutic agents that could improve the way cancer is treated: PNT2002 is a PSMA-targeted 177Lu-based radiopharmaceutical therapy for metastatic castration-resistant prostate cancer (mCRPC) and combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu. Every year in the United States 70,000 men are eligible for treatment for mCRPC.
PNT2002 is currently in its Phase 3 study designed to evaluate superiority to the standard of care in mCRPC pre-chemotherapy patients who have failed one androgen receptor pathway inhibitor. PNT2003 is a somatostatin receptor (SSTR) targeted radioligand therapy with no-carrier-added 177Lu, in development for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). SSTRs are seen as ideal targets for NET therapy and somatostatin analogs (SSAs) have been developed with anti-secretory and anti-proliferative effects for NET therapy, and randomized clinical trials with somatostatin analogs have demonstrated efficacy.
PNT2003 is currently in a Phase 3 trial.