-- 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

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.

Logo - https://mma.prnewswire.com/media/652491/MENARINI_Group_Logo.jpg

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.

Elcin Barker Ergun, the Chief Executive Officer of Menarini, commented, "We are 
excited about the potential for elacestrant to be approved for treatment of 
patients with advanced or metastatic ER+/HER2- breast cancer, which constitutes 
about 70% of breast cancer and remains an area of significant unmet medical 
need." Barker Ergun continued, "Elacestrant has shown statistically significant 
efficacy over current standard of care medications both for overall population 
and in patients whose tumors harbor an ESR1 mutation, one of the most difficult 
to treat mechanisms of acquired resistance that develops in the later stages of 
metastatic/advanced breast cancer."

Chhaya Shah, SVP of Clinical and Regulatory at Radius, commented, "We enrolled 
and completed the EMERALD trial in a high-quality manner, delivered positive 
topline results, and prepared the submission of the NDA to the FDA. The 
submission is a significant milestone for both companies, and we appreciate the 
strong, collaborative effort of many hard-working employees at Radius and 
Menarini, investigators, patients, and their families. Together we look forward 
to advancing elacestrant and providing the opportunity to benefit patients."

Nassir Habboubi, Global Head of Pharma R&D of Menarini Group, added, "The 
Menarini and Radius teams have done an excellent job working together since our 
partnership began in July of 2020." Habboubi continued, "We plan to test 
elacestrant in earlier treatment lines, combination trials, and metastatic 
breast cancer that has metastasized to the brain. These details are to be 
communicated by us throughout 2H 2022 and 1H 2023."

With the submission of the NDA, based on the original agreement of the 
Companies, Menarini takes over activities and will be responsible for 
registration and commercialization. Menarini plans to use its fully owned 
subsidiary in the U.S., Stemline Therapeutics, to commercialize elacestrant if 
approved by the FDA.

About Elacestrant (RAD1901) and EMERALD Phase 3 Study
Elacestrant is an investigational selective estrogen receptor degrader (SERD), 
out-licensed to Menarini Group, which is being evaluated for potential use as a 
once daily oral treatment in patients with ER+/ HER2- advanced breast cancer. 
In 2018, elacestrant received fast track designation from the FDA. Preclinical 
studies completed prior to EMERALD indicate that the compound has the potential 
for use as a single agent or in combination with other therapies for the 
treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open 
label, active-controlled study evaluating elacestrant as second- or third-line 
monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study 
enrolled 477 patients who have received prior treatment with one or two lines 
of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were 
randomized to receive either elacestrant or the investigator's choice of an 
approved hormonal agent. The primary endpoint of the study was progression-free 
survival (PFS) in the overall patient population and in patients with estrogen 
receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of 
overall survival (OS), objective response rate (ORR), and duration of response 
(DOR).

About Menarini
The Menarini Group is a leading international pharmaceutical and diagnostics 
company, with a turnover of over $4 billion and over 17,000 employees. Menarini 
is focused on therapeutic areas with high unmet needs with products for 
cardiology, oncology, pneumology, gastroenterology, infectious diseases, 
diabetology, inflammation, and analgesia. With 18 production sites and 9 
Research and Development centers, Menarini's products are available in 140 
countries worldwide. For further information, please visit www.menarini.com.

About Radius
Radius is a global biopharmaceutical company focused on addressing unmet 
medical needs in the areas of bone health, orphan diseases, and oncology. 
Radius' lead product, TYMLOS(R) (abaloparatide) injection, was approved by the 
U.S. Food and Drug Administration for the treatment of postmenopausal women 
with osteoporosis at high risk for fracture. The Radius clinical pipeline 
includes investigational abaloparatide injection for potential use in the 
treatment of men with osteoporosis; the investigational drug, elacestrant 
(RAD1901), for potential use in the treatment of hormone-receptor positive 
breast cancer out-licensed to Menarini Group; and the investigational drug 
RAD011, a synthetic cannabidiol oral solution with potential utilization in 
multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease 
areas, initially targeting Prader-Willi syndrome, Angelman syndrome, and 
infantile spasms.

Forward-Looking Statements of Radius
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 for elacestrant for the treatment of 
patients with advanced ER+/HER2- breast cancer, including the potential to be a 
new standard of care, the length of priority review, if granted, of the 
elacestrant NDA by the FDA, the expected regulatory submission in the European 
Union; and ongoing clinical development activities with respect to elacestrant.

These forward-looking statements are based on Radius 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: the adverse impact the ongoing COVID-19 pandemic, including the 
delay of reviews and approvals by the FDA and other regulatory authorities, 
delays in the supply of drug product, risks related to Radius' collaboration 
with Menarini, including its ability to scale its sales and marketing 
operations if elacestrant is approved for marketing; Menarini's ability to 
obtain favorable pricing and reimbursement for elacestrant, if approved; the 
risk that the potential market for elacestrant is not as anticipated; the risk 
of adverse side effects related to elacestrant are identified; risks related to 
manufacturing, supply and distribution of elacestrant; and the risk of 
litigation or other challenges regarding Radius' intellectual property rights. 
These and other important risks and uncertainties discussed in Radius' filings 
with the Securities and Exchange Commission (SEC), including under the caption 
"Risk Factors" in Radius' Annual Report on Form 10-K for the year ending 
December 31, 2021 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. Any such forward-looking statements 
represent Radius' management's estimates as of the date of this press release. 
While Radius may elect to update such forward-looking statements at some point 
in the future, Radius disclaims any obligation to do so, even if subsequent 
events cause our views to change. These forward-looking statements should not 
be relied upon as representing Radius' views as of any date subsequent to the 
date of this press release.

SOURCE Menarini Industrie Farmaceutiche Riunite