Lantheus Acquires Global Rights to Life Molecular Imaging’s Novel Therapeutic and Diagnostic Pair Targeting GRPR for Prostate and Breast Cancers

Rhea-AI Summary

Lantheus Holdings, a leader in radiopharmaceuticals, has acquired global rights to Life Molecular Imaging's RM2, targeting the gastrin-releasing peptide receptor (GRPR) for prostate and breast cancers. The acquisition is valued at $35 million upfront with additional regulatory milestone payments and royalties. This deal enhances Lantheus' prostate cancer portfolio and introduces a new pipeline for breast and other cancers. RM2, including the radiotherapeutic 177Lu-DOTA-RM2 and the radiodiagnostic 68Ga-DOTA-RM2, has demonstrated favorable safety and dose-dependent efficacy. Lantheus plans to initiate a Phase 1/2a study in 2025, aiming to expand access to radiotheranostics for patients not suitable for PSMA-targeted therapies.

Positive

• Lantheus acquires global rights to Life Molecular Imaging's RM2 for $35 million plus milestone payments and royalties.
• The acquisition strengthens Lantheus' prostate cancer portfolio and expands its pipeline to include breast cancer.
• RM2 targets cancers overexpressing GRPR, including prostate, breast, lung, and others, with favorable safety and dosimetry profiles.
• Lantheus plans to begin a Phase 1/2a study in 2025, potentially expanding treatment options for prostate cancer patients.

Negative

• None.

Insights

Financial Analyst

The acquisition of Life Molecular Imaging's rights to RM2 represents a strategic expansion for Lantheus Holdings, valued at $35 million with additional potential milestone payments and royalties. This move broadens Lantheus' portfolio, particularly strengthening its position in the prostate cancer segment while venturing into breast cancer diagnostics and therapeutics. The financial structure, consisting of upfront and contingency payments, shows a balanced approach to risk and reward.

Short-term implications include the financial cost of the acquisition and integration efforts. However, the long-term potential could be substantial, given the high demand for novel cancer treatments. The companion diagnostic (68Ga-DOTA-RM2) enhances the value proposition by providing a targeted approach, which could lead to higher adoption rates within oncological practices.

For investors, this acquisition aligns with Lantheus' strategy to diversify and strengthen its portfolio. Analyzing valuation metrics post-acquisition will be essential to gauge the financial impact accurately. The focus on radiotheranostics, a rapidly growing field, positions Lantheus favorably in the biopharmaceutical market.

Oncology Doctor

The acquisition of 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 by Lantheus is noteworthy from a clinical perspective. GRPR-targeted therapies offer a new avenue for treating patients who may not respond to PSMA-targeted options. This is particularly relevant for prostate cancer patients, where treatment resistance can be a critical challenge.

Additionally, the inclusion of breast cancer into their pipeline expands the potential patient base. The first-in-human dosimetry studies showing safety and efficacy are promising. However, it is essential to await further clinical data from the planned Phase 1/2a study to validate these findings in a broader patient population.

For patients, this could mean more tailored treatment options, especially in cases of advanced or resistant cancers. The dual approach of using 68Ga-DOTA-RM2 as a diagnostic tool and 177Lu-DOTA-RM2 as a therapeutic agent could streamline treatment protocols, potentially improving outcomes and quality of life.

Market Research Analyst

The acquisition underscores Lantheus' commitment to harnessing innovative radiotheranostics for cancer treatment, a field gaining significant traction. The GRPR-targeted approach addresses a niche market, potentially offering a competitive edge over existing therapies. By diversifying into breast cancer, Lantheus opens new revenue streams beyond its established prostate cancer focus.

The strategic importance is amplified by the existing clinical data, which supports the efficacy and safety of these compounds. This could accelerate market adoption post-regulatory approval. Moreover, the collaboration with Life Molecular Imaging ensures continuity in development, leveraging their expertise to mitigate risks associated with clinical trials.

From an investor's viewpoint, this acquisition could enhance Lantheus' market positioning and drive future growth. Monitoring the upcoming clinical trials and regulatory milestones will be important in assessing the full potential of these acquisitions.

Deal Further Strengthens Lantheus’ Prostate Cancer Portfolio and Expands Pipeline to Include Breast Cancer

BEDFORD, Mass., June 27, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced its acquisition of the global rights of Life Molecular Imaging’s (“Life Molecular”) RM2, targeting the gastrin-releasing peptide receptor (GRPR), including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, referred to as ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2. This acquisition strengthens Lantheus’ presence in prostate cancer and expands its pipeline to include breast and other cancers. The agreement includes global rights¹ to this radiotheranostic pair for an upfront payment of $35 million and potential regulatory milestone payments plus royalties.

Lantheus’ acquisition of worldwide rights to ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2 underscores its dedication to pioneering cancer care and marks a significant step towards addressing unmet medical needs in prostate and breast cancer treatment. RM2 was discovered at the Universities Bern and Basel and development was originally performed by Bayer Pharma AG. It was subsequently licensed to Life Molecular. ⁶⁸Ga-DOTA-RM2 targets cancers overexpressing GRPR, such as prostate, breast, lung, pancreatic, colorectal, gastric and ovarian cancers and has been extensively studied in various tumor types. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of ¹⁷⁷Lu-DOTA-RM2. Lantheus intends to begin a Phase 1/2a study with ¹⁷⁷Lu-DOTA-RM2 in prostate cancer patients in 2025. ⁶⁸Ga-DOTA-RM2 will be used as a companion diagnostic.

“While new PSMA-targeted diagnostics and therapeutics are transforming prostate cancer care, there are many patients for whom PSMA-targeted therapy may not be appropriate,” said Brian Markison, Lantheus CEO. “Targeting GRPR with ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2 creates a potential new option to expand access to radiotheranostics for more prostate cancer patients. This expands our therapeutic offerings and opens avenues for commercial synergies.”

Life Molecular, a subsidiary of Life Healthcare Group, will complete the Phase 1/2a dose escalation study in collaboration with Lantheus.

“With Lantheus’ experience developing and providing access to radiotheranostics in cancer, we are confident in our decision to hand them the reins for this promising theranostic pair and are honored to work with them toward improving the future for people with prostate and breast cancer,” said Ludger Dinkelborg, CEO, Life Molecular Imaging.

Wolf, Greenfield & Sacks, P.C. acted as legal advisor to Lantheus in connection with the transaction.

About GRPR
Gastrin-releasing peptide receptor (GRPR) is a member of the bombesin G protein-coupled receptor family. It has been found to be overexpressed in multiple cancers, including prostate, breast, lung and others.²

About Lantheus 
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.

About Life Molecular Imaging (Life Molecular)
Life Molecular Imaging (Life Molecular) is a global radiopharmaceutical company dedicated to developing and offering novel cutting-edge radiopharmaceuticals that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Life Molecular is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.

About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative radiopharmaceuticals. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.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 “intends,” “may,” “potential,” “will,” 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 using ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2, including the Phase 1/2a study; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for ¹⁷⁷Lu-DOTA-RM2 or ⁶⁸Ga-DOTA-RM2; (iii) our ability to launch ¹⁷⁷Lu-DOTA-RM2 or ⁶⁸Ga-DOTA-RM2 as commercial products; (iv) the market receptivity to ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2 as radiotheranostics; (v) the existence, availability and profile of competing products; (vi) our ability to obtain and maintain adequate coding, coverage and payment for ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2; (vii) the safety and efficacy of ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2; (viii) the intellectual property protection of ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2; (ix) our ability to successfully develop and scale the manufacturing capabilities to support the launch of ¹⁷⁷Lu-DOTA-RM2 and ⁶⁸Ga-DOTA-RM2; and (x) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).

¹ Lantheus’ global rights are exclusive for therapeutic fields in all countries and diagnostic fields in the Americas and co-exclusive with Life Molecular for diagnostic fields outside of the Americas.

² Ma, Y., Gao, F. Advances of radiolabeled GRPR ligands for PET/CT imaging of cancers. Cancer Imaging 24, 19 (2024). https://doi.org/10.1186/s40644-024-00658-y

Contacts:

Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com

FAQ

What company recently acquired global rights to Life Molecular Imaging's RM2?

Lantheus Holdings acquired the global rights to Life Molecular Imaging's RM2.

What is the value of the upfront payment for the acquisition of RM2 by Lantheus?

The upfront payment for the acquisition is $35 million.

What cancers does RM2 target?

RM2 targets prostate, breast, lung, pancreatic, colorectal, gastric, and ovarian cancers.

When does Lantheus plan to begin the Phase 1/2a study for 177Lu-DOTA-RM2?

Lantheus intends to begin the Phase 1/2a study in 2025.

What receptor does RM2 target in cancers?

RM2 targets the gastrin-releasing peptide receptor (GRPR).