On July 23, 2020 The Menarini Group and Radius Health, Inc. (Nasdaq: RDUS) reported that the companies have entered into an exclusive global license agreement for development and commercialization of elacestrant (Press release, Radius, JUL 23, 2020, View Source [SID1234562294]).
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Elacestrant is an oral SERD, a selective estrogen receptor degrader, currently being evaluated in the EMERALD Phase 3 study as hormonal treatment for postmenopausal women and men with advanced ER+/HER2- breast cancer.
Under the agreement, Menarini Group will be responsible for worldwide commercialization of elacestrant, after the completion of EMERALD Phase 3 study and, assuming positive results, successful registration of elacestrant.
Elcin Barker Ergun, Chief Executive Officer of Menarini Group, commented: "Elacestrant is a perfect addition to our global oncology portfolio following our recent acquisition of Stemline Therapeutics and entering the US biopharmaceuticals market. Oral SERDs can potentially lead to new treatment paradigms in breast cancer and we look forward to advancing elacestrant’s development to provide novel options that can help patients."
Kelly Martin, Chief Executive Officer of Radius commented, "Menarini will be a terrific global partner on this program and, given their recent investment and expansion in the oncology space, we are extremely pleased to have completed this transaction with them." Martin further commented that "this transaction is a significant step for Radius and provides us with flexibility in moving forward."
As part of the agreement, Radius will receive an upfront payment of $30 million and up to $320 million in additional payments based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health on global net sales.
Radius will continue to be responsible for the conduct and completion of the Phase 3 EMERALD study through NDA filing. Costs associated with this activity will be reimbursed by Menarini Group.