Lantheus and POINT Biopharma Announce Strategic Alliance and Exclusive License Agreement for Commercialization of PNT2002 and PNT2003, The Canadian Business Journal

This collaboration combines POINT’s expertise in next-generation radioligand development and manufacturing with Lantheus’ commercial leadership in PSMA PET and radiopharmaceuticals.

Expanding the Ranteus portfolio with exclusive worldwide rights licenses, excluding certain territories¹, Two late-stage therapies

NORTH BILLERICA & INDIANAPOLIS, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH) improves patient outcomes through diagnostics, radiotherapy and artificial intelligence solutions It’s a company that works. POINT Biopharma Global Inc. (“POINT”) (NASDAQ: PNT) today announced a series of strategic collaborations.Ranteus Licenses Exclusive Worldwide Rights Agreement¹ To POINT’s PNT2002 and PNT2003 product candidates.

Once the deal is complete, in exchange for exclusive worldwide rights to¹Ranteus has entered into an agreement between the two contracts to POINT, with potential 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 commercials. Make upfront payments totaling $260 million. milestone. In addition, Ranteus will pay his POINT royalties of 20% for PNT2002 and 15% for PNT2003, subject to conditions, above certain financial thresholds on net sales. Additional terms of the agreement are summarized below and a website containing more information regarding the collaboration can be accessed at www.strategiccollaboration.net.

The agreement expands Ranteus’ radiopharmaceutical portfolio with two late-stage therapeutic candidates and PNT2002 expands Ranteus’ prostate cancer franchise. For POINT, this agreement combines PNT2002 and PNT2003 with ideal commercialization partners to offset launch and marketing risks while maintaining the value and independence of POINT’s next-generation radioligand platform. Lantheus expects the deal to drive long-term sustainable earnings and free cash flow growth and accretive adjusted earnings per share (adjusted EPS) shortly after commercialization of PNT2002 .

Under the agreement, POINT will fund and complete the Phase 3 SPLASH trial of PNT2002, after which Ranteus will work with POINT to submit a New Drug Application (NDA). At PNT2003, POINT will facilitate the completion of her ongoing OZM-067 study in Canada sponsored by the University Health Network (UHN), and Lantheus will prepare and submit regulatory submissions in the United States. A committee that oversees clinical studies, regulatory submissions, manufacturing and commercial readiness for both PNT2002 and PNT2003. POINT has developed commercial capacity for both PNT2002 and PNT2003 to manufacture clinical and commercial supplies. Ranteus has the right to commercialize both assets following regulatory approval.

Mary Ann Heino, President and CEO of Ranteus, said: “Ranteus has extensive experience in radioisotope supply chains and distribution, recognized leadership in radiopharmaceuticals and prostate cancer, a well-established commercial infrastructure, and relationships with relevant healthcare professionals and hospitals. We believe we are uniquely positioned to unlock the significant commercial potential of these two product candidates, which we believe will enhance the long-term revenue and profit growth potential of Lantheus. We look forward to working with the talented POINT team to advance our purpose of finding, fighting and tracking disease to deliver better patient outcomes.”

“Lanteus is a proven commercial leader in the field of radiopharmaceuticals,” said Dr. Joe McCann, CEO of POINT Biopharma. will reduce the need for diluted funding and allow the company to focus on its pipeline of next-generation radioligands that have the potential to transform the field of precision oncology.Supporting the launch of PNT2002 and PNT2003; We are pleased to continue to develop and expand our manufacturing capacity to continue the development of our pan-cancer FAP-α program, PNT2004, currently in Phase 1, and our next-generation actinium-225, PNT2001, in 2023. The PSMA program is about to begin Phase 1. We founded POINT to accelerate the discovery, development and global access of life-changing radiopharmaceuticals.With this collaboration, POINT is more than ever. It puts us in a better position to carry out our mission.”

The collaboration will diversify the Lantheus portfolio with two radiotherapeutic agents that can improve the way cancer is treated.

• PNT2002 is a PSMA target ¹⁷⁷A Lu-based radiopharmaceutical therapy for metastatic castration-resistant prostate cancer (mCRPC) that combines the PSMA-targeting ligand PSMA-I&T with a carrier-free beta-emitting radioisotope. ¹⁷⁷Le. 70,000 men in the United States are eligible for treatment for her mCRPC each year.² PNT2002 is currently in a phase 3 trial designed to evaluate its superiority over standard of care in pre-mCRPC chemotherapy patients who have failed one of the androgen receptor pathway inhibitors.
• PNT2003 is a carrier-free radioligand therapy targeting the somatostatin receptor (SSTR). ¹⁷⁷Lu, developing gastroenteropancreatic neuroendocrine tumors (GEP-NET). SSTRs are considered ideal targets for NET therapy, and somatostatin analogues (SSAs) have been developed with antisecretory and antiproliferative effects of NET therapy and have been demonstrated in randomized clinical trials using somatostatin analogues. Proven effective. PNT2003 is currently in Phase 3 trials.

Additional Terms of Contract
Ranteus will fund an all-cash license with exclusive worldwide rights, excluding certain territories.¹, PNT2002 and PNT2003, Ranteus has cash on its balance sheet and is committed to funding. The contractual, milestone-based structure will enable Ranteus to maintain an attractive financial profile and create opportunities to generate strong free cash flow.

In exchange for Ranteus obtaining exclusive worldwide rights to PNT2002, excluding certain territories, POINT will receive an upfront payment of $250 million and up to $250 million, subject to US regulatory approvals. Other terms include a royalty of 20% on net sales and up to an additional $1.3 billion in various net sales milestone payments. meet the possibilities. For PNT2003, POINT is a $10M upfront payment, up to $30M surcharge subject to US regulatory approval, a royalty of 15% on net sales, and various net sales milestone payments. Receive up to $275 million in additional potential. For more information, see the SEC filings regarding Ranteus and his POINT contract.

The PNT2002 and PNT2003 license agreements are subject to Hart-Scott-Rodino antitrust clearance and customary termination conditions, which are expected to be completed in the first half of 2023. More information about the agreement is available online at www.strategiccollaboration.net.

SVB Securities acted as financial advisor to Lantheus.

About Ranteus
With more than 65 years of experience delivering life-changing science, Lantheus is dedicated to improving patient outcomes through diagnostics, radiotherapy and artificial intelligence solutions that enable clinicians to discover, combat and track disease. is working on Lantheus is headquartered in Massachusetts with offices in New Jersey, Canada and Sweden. For more information, please 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 cancer-fighting radioligands. POINT has a portfolio of radiopharmaceutical assets, an experienced management team, an industry-leading pipeline, in-house manufacturing capabilities, actinium-225 (225Ac) and lutetium-177 (177Lu). POINT’s ongoing clinical trials include FRONTIER, a Phase 1 trial of PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and metastatic castration-resistant prostate cancer. includes SPLASH, a Phase 3 trial of PNT2002 for people with (mCRPC). ) after secondary hormonal therapy. For more information on the SPLASH trial, please visit https://www.splashtrial.com. For more information about POINT Biopharma Global Inc., please visit https://www.pointbiopharma.com/.

Safe harbor for forward-looking statements and cautionary statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. It is subject to risks and uncertainties and is made pursuant to the safe harbor provisions of Section 27A of the Securities Act. 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements “believe,” “continue,” “may,” “make,” “expect,” “anticipate,” “see,” “could,” May be identified by the use of terms such as “plan”. “Positioning”, “Potential”, “Will”, “Will” and other similar terms. Such forward-looking statements are subject to current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. Based on The inclusion of forward-looking statements should not be considered 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. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law. Risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements include: (i) the POINT Phase 3 SPLASH trial of PNT2002 and the OZM-067 trial of PNT2003; Including the timing and potential results of clinical trials. (ii) Timing and Consequences of Hart-Scott-Rodino Antitrust Clearance. (iii) any delay or failure to obtain positive regulatory results from FDA and regulatory agencies for PNT2002 and PNT2003; (iv) Lantheus’ ability to successfully launch PNT2002 or PNT2003 as a commercial product; (v) market acceptance of his PNT2002 or PNT2003 as a radiopharmaceutical therapy; (vi) presence, availability and profile of competing products and therapies; (vii) our ability to obtain and retain proper coding, coverage and payment for PNT2002 and PNT2003; (viii) safety and efficacy of PNT2002 and PNT2003; (ix) PNT2002 and PNT2003 Intellectual Property Protection. (x) POINT’s ability to successfully develop and expand manufacturing capabilities to support the launch of PNT2002 and PNT2003; (xi) the risks and uncertainties discussed in Lantheus and POINT’s filings with the Securities and Exchange Commission (described in the Risk Factors section of its Annual Report on Form 10-K and Quarterly Report on Form 10-Q; ).

contact address:
rantheus
Mark Kinnerney
Vice President of Investor Relations
978-671-8842
[email protected]

Melissa Downes
Senior Director, Corporate Communications
646-975-2533
[email protected]

POINT Biopharma
Daniel Pearlstein
Associate Director, Corporate Strategy
[email protected]

David Rosen
Algot Partners
212-600-1902
[email protected]

¹ Excludes Japan, South Korea, China (including Hong Kong, Macao and Taiwan), Singapore and Indonesia held by POINT.
² DRG/Clarivate Prostate Cancer Disease Status and Predictions 2022.

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