Radius Pharmaceuticals sells off part of its royalties, milestones in breast cancer drug Orserdu to DRI Healthcare

Radius Pharmaceuticals is pulling in an upfront payment of $130 million from DRI Healthcare as part of a royalty purchase agreement for its breast cancer drug elacestrant, the Boston-based biotech announced Monday.

Radius Pharmaceuticals, a subsidiary of Radius Health, could also receive another $10 million from DRI if “certain events” happen. Radius will keep more than $200 million in potential commercial milestones from the Menarini Group, which snagged global commercial and development rights to elacestrant for only $30 million in July 2020.

In the original agreement, Radius got development and commercial milestone payments and a tiered royalty on global net sales of elacestrant, an oral selective estrogen receptor degrader, or SERD.

In exchange for $130 million, DRI Healthcare will get quarterly “low to high” single-digit tiered royalties on worldwide sales of the drug, marketed as Orserdu. DRI said it expects the first payment in the fourth quarter of 2023. The company will also get milestone payments of up to $40 million based on sales performance.

Radius says it’ll use the funds from the purchase agreement to “support the growth of its bone health business,” including its lead drug Tymlos, “and other business development opportunities.”

This is the second time that DRI has gone after Orserdu royalties, which is expected to pull in $175 million in 2023 sales. DRI Healthcare added in its statement that Orserdu had performed better than its initial expectations at the time of its transaction with Eisai — referencing a June deal when Eisai sold royalty interest in the drug to DRI for $85 million.

Behzad Khosrowshahi

“We are excited to add this asset to our growing royalty portfolio, as it fits with our investment criteria for a high-quality and long duration asset on a drug that meets a high unmet medical need,” DRI CEO Behzad Khosrowshahi said in a statement.

Radius describes elacestrant, developed by Radius and marketed as Orserdu by Stemline (a Menarini subsidiary) in the US, as the “first and only treatment” approved for ER+/HER2-, ESR1- mutated advanced or metastatic breast cancer. It’s patent-protected until January 2038.

The FDA approved the drug in January 2023 and it’s seen some headway in Europe as well, with the Committee for Medicinal Products for Human Use from the European Medicines Agency giving the thumbs-up for an approval as a monotherapy earlier this summer.

It’s approved for postmenopausal women or adult men whose disease is still progressing even after at least one line of endocrine therapy. The recommended dosage of Orserdu is one 345 mg tablet taken orally, once daily, with food.

The approval was based on data from the EMERALD study, where the drug achieved both primary endpoints in a study of patients with ER+/HER2- breast cancer. The drug beat the standard of care for progression-free survival in the overall population and PFS with tumors harboring estrogen receptor 1 mutations, or ESR1. Fuller data from the trial showed the efficacy was much higher for patients harboring the ESR1 mutations, bringing on more investor interest.

Other companies have tried and failed to develop an effective oral SERD: Sanofi failed its first big test for its SERD amcenestrant after it didn’t meet its progression-free survival endpoints in March 2022. Roche also flunked out in a Phase II in April 2022.

Other oral SERDs are in development, however, including AstraZeneca’s camizestrant. The company is testing the drug in a few Phase III trials after a positive readout in the SERENA-2 Phase II trial. In a February earnings call, AstraZeneca CEO Pascal Soriot said he saw blockbuster potential in 10 different developing programs, including its SERD.

AstraZeneca developed another line of treatment, an injectable SERD called fulvestrant, which earned an approval for HER2- advanced breast cancer in 2017.

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