Menarini Group and Radius Health Announce Global License Agreement for the Development and Commercialization of Elacestrant
WALTHAM, Mass. and FLORENCE, Italy, July 23, 2020 (GLOBE NEWSWIRE) -- The Menarini Group and Radius Health, Inc. (Nasdaq: RDUS) announced today that the companies have entered into an exclusive global license agreement for development and commercialization of elacestrant.
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.
About Menarini Group
About Elacestrant (RAD1901)
About EMERALD Phase 3 Study
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in advanced/metastatic ER-positive (ER+)/HER2- breast cancer patients. The study will enroll approximately 460 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study will be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study will be progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints will include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR). Top-line data from the EMERALD study is expected to be reported in the second half of 2021.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential market opportunity for elacestrant, including the potential achievement of development and sales milestones related to elacestrant; our expectations regarding the completion of, and timing of results from, the EMERALD study; our expectations regarding an NDA filing in the U.S. and other regulatory filings globally for elacestrant; our expectations regarding our license agreement with Menarini for elacestrant; and the potential clinical uses and therapeutic and other benefits of elacestrant, abaloparatide-SC, abaloparatide-patch, and RAD140.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Our inability to ensure the timing of results from the EMERALD trial or that its primary endpoint will be met; Menarini’s inability to ensure that elacestrant will obtain regulatory approval or be successfully commercialized, if approved, including as a result of risks related to coverage, pricing and reimbursement, manufacturing, supply and distribution, and potential adverse impacts on the EMERALD trial or Menarini’s business from the ongoing COVID-19 pandemic; risks related to competitive products; risks of litigation or other challenges regarding intellectual property rights; risks that adverse side effects of elacestrant will be identified during commercialization, if approved, or during development activities. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.
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