BeOne Medicines Ltd. (NASDAQ:ONC) on Monday agreed to sell its royalty rights on the worldwide sales, excluding China, of Amgen Inc.’s (NASDAQ:AMGN) Imdelltra (tarlatamab-dlle) for up to $950 million to Royalty Pharma Inc. (NASDAQ:RPRX).
Under the terms of the agreement, BeOne will receive an upfront payment of $885 million, with the option to sell remaining royalties within 12 months for up to $65 million.
BeOne will share in a portion of the royalty on annual sales above $1.5 billion, and will maintain royalty and all other rights to other assets under the terms of the existing collaboration with Amgen, including xaluritamig, a first-in-class STEAP1 x CD3 XmAb currently being studied in patients with metastatic castration-resistant prostate cancer (mCRPC).
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Imdelltra is a first-in-class immunotherapy that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing cells.
Imdelltra is approved in the United States for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after receiving platinum-based chemotherapy.
Tarlatamab is currently being evaluated across a broad clinical development program spanning both early- and late-stage small cell lung cancer.
Ongoing studies include DeLLphi-303, a Phase 1b trial assessing tarlatamab in combination with standard-of-care therapies as a first-line treatment for extensive-stage SCLC (ES-SCLC).
DeLLphi-304, a pivotal Phase 3 study, is comparing tarlatamab monotherapy with standard chemotherapy in the second-line setting for ES-SCLC.
In limited-stage disease, the DeLLphi-306 trial is a randomized, placebo-controlled Phase 3 study investigating tarlatamab after concurrent chemoradiotherapy.
Additional studies are exploring alternative formulations and dosing strategies: DeLLphi-308, a Phase 1b trial, is testing a subcutaneous version of tarlatamab in patients with previously treated ES-SCLC, while DeLLphi-309, a Phase 2 study, is evaluating different intravenous dosing regimens in the same patient population.
The transaction comes amid heightened deal activity in oncology. In July, AstraZeneca Plc (NASDAQ:AZN) was reportedly in talks with Summit Therapeutics Inc. (NASDAQ:SMMT) about a partnership worth up to $15 billion. The deal would give AstraZeneca the rights to a lung cancer drug called ivonescimab.
Concurrently, on Monday, the U.S. Food and Drug Administration (FDA) broadened the approved use of Amgen’s Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as ‘bad cholesterol.’
The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease.
In addition to expanding Repatha’s label to include adults at increased risk of MACE, the FDA also expanded the use of Repatha alone (monotherapy) to include patients with a rare, genetic form of high cholesterol known as homozygous familial hypercholesterolemia (HoFH).
The agency also emphasized that Repatha should be used alongside diet and exercise to manage high cholesterol. Repatha was first approved in 2015.
Price Action: ONC shares fell 0.53% to $312.01 at last check Monday. AMGN declined 1.82% to $288.36, while RPRX slipped 1.16% to $35.90.
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