Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant

• Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
• Priority Review requested; if accepted, anticipate an 8-month FDA review
• Positive EMERALD study data previously announced on October 20, 2021
• First, and currently only, investigational oral SERD with positive topline results
• Additional data presented at SABCS (December 2021) and ASCO (June 2022)
• Plan to file marketing authorization application for elacestrant in the EU in 2H 2022

FLORENCE, Italy and BOSTON, June 22, 2022 /PRNewswire/ -- The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

As part of the submission, the Companies have requested Priority Review with the FDA. If Priority Review is granted, the Companies anticipate that the FDA would conduct an 8-month review, incorporating a 6-month priority designation review.

The NDA submission is based on positive phase 3 data from the EMERALD study that was previously announced on October 20, 2021. EMERALD met both of its primary endpoints, which were progression-free survival (PFS) in the overall population and PFS in the estrogen receptor 1 (ESR1) mutation subgroup as compared to standard of care (SoC) with the options of fulvestrant or an aromatase inhibitor.

Elacestrant is the first and currently only investigational oral SERD to show positive topline results in a pivotal trial for the treatment of ER+/HER2- advanced or metastatic breast cancer in postmenopausal women, and men. Notably, these results showed elacestrant is also active in patients whose tumors harbor an ESR1 mutation, one of the key resistance mechanisms that develops in later treatment lines of metastatic breast cancer.

Following the completion of EMERALD, data from the study was presented at the San Antonio Breast Cancer Symposium (SABCS) on December 8, 2021, published in the Journal of Clinical Oncology (JCO) on May 18, 2022, and further subset analyses were presented at the 2022 American Society of Clinical Oncology (ASCO) annual Meeting on June 6, 2022.