NORTH BILLERICA, Mass. and INDIANAPOLIS, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (”Lantheus”) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, and POINT Biopharma Global Inc. (“POINT”) (NASDAQ: PNT), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, today announced a set of strategic collaboration agreements in which Lantheus will license exclusive worldwide rights1 to POINT’s PNT2002 and PNT2003 product candidates.
Upon consummation of the agreements, in exchange for the exclusive worldwide rights1, 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. Additional terms of the agreements are summarized below and a website with more information about the collaboration is accessible at www.strategiccollaboration.net.
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.
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1 Excluding the following territories: Japan, South Korea, China (including Hong Kong, Macau and Taiwan), Singapore, and Indonesia, which are retained by POINT.
“These exclusive license agreements and collaborations leverage the complementary strengths of both companies in radiopharmaceutical oncology and enhance the potential impact that these compelling therapeutic candidates could provide to patients,” said Mary Anne Heino, President and CEO of Lantheus. “Lantheus has extensive radioisotope supply chain and distribution experience, recognized leadership in radiopharmaceuticals and prostate cancer, a well-established commercial infrastructure, and longstanding relationships across relevant healthcare stakeholders and hospitals. Our company is uniquely positioned to unlock the significant commercial potential of these two product candidates, which we believe will enhance the long-term revenue and earnings growth potential of Lantheus. We look forward to working with the talented POINT team as we advance our purpose to Find, Fight and Follow disease to deliver better patient outcomes.”
“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. Their experience with these complex products and established footprint in commercializing PYLARIFY and AZEDRA makes them an ideal collaborator for these programs,” said Joe McCann, Ph.D., CEO of POINT Biopharma. “This collaboration also 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. We are excited to continue developing and scaling our manufacturing capabilities to support the PNT2002 and PNT2003 launches and continue development of PNT2004, our pan-cancer FAP-α program, which is currently in Phase 1, and PNT2001, our actinium-225 next-generation PSMA program which is expected to begin Phase 1 in 2023. We founded POINT to accelerate the discovery, development, and global access to life-changing radiopharmaceuticals, and with this collaboration, POINT is now better positioned than ever to execute on our mission.”
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.2 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.
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2 DRG / Clarivate Prostate Cancer Disease Landscape and Forecast 2022.
Additional Terms of the Agreements
Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. The milestone-based structure under the agreements allows Lantheus to maintain its attractive financial profile and creates the opportunity to generate strong free cash flow.
In exchange for Lantheus receiving exclusive worldwide rights, excluding certain territories, for PNT2002, POINT will receive a $250 million upfront payment, an additional payment up to $250 million upon U.S. regulatory approval, and, once certain return on investment financial thresholds have been achieved and other conditions met, royalties of 20% on net sales, as well as the potential for up to an additional $1.3 billion in various net sales milestone payments. For PNT2003, POINT will receive a $10 million upfront payment, up to an additional $30 million upon U.S. regulatory approval, royalties of 15% on net sales, as well as the potential for up to an additional $275 million in various net sales milestone payments. For additional information, please refer to Lantheus’ and POINT’s SEC filings related to the agreements.
The PNT2002 and PNT2003 license agreements are subject to Hart-Scott-Rodino antitrust clearance and customary closing conditions, which are expected to be satisfied in the first half of 2023. More information about the agreements is accessible online at www.strategiccollaboration.net.
SVB Securities served as financial advisor to Lantheus.
About Lantheus
With more than 65 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
About POINT Biopharma Global Inc.
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision medicine by combining a portfolio of radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 (225Ac) and lutetium-177 (177Lu). POINT’s active clinical trials include FRONTIER, the Phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the Phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. More information about the SPLASH trial can be found at https://www.splashtrial.com. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “believe,” "continue,” “could,” “creates,” "expected,” “expects,” “looks,” “may,” “plans,” “positioned,” “potential,” “will,” “would” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the timing and potential outcomes of clinical studies, including POINT’s Phase 3 SPLASH trial for PNT2002 and the OZM-067 study for PNT2003; (ii) the timing and outcome of Hart-Scott-Rodino antitrust clearance; (iii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and regulatory authorities for PNT2002 and PNT2003; (iv) Lantheus’ ability to successfully launch PNT2002 or PNT2003 as commercial products; (v) the market receptivity to PNT2002 or PNT2003 as radiopharmaceutical therapies; (vi) the existence, availability and profile of competing products and therapies; (vii) our ability to obtain and maintain adequate coding, coverage and payment for PNT2002 and PNT2003; (viii) the safety and efficacy of PNT2002 and PNT2003; (ix) the intellectual property protection of PNT2002 and PNT2003; (x) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002 and PNT2003; and (xi) the risks and uncertainties discussed in Lantheus’ and POINT’s filings with the Securities and Exchange Commission (including those described in the Risk Factors section in their Annual Reports on Form 10-K and their Quarterly Reports on Form 10-Q).
