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

PR96660

 

FLORENCE, Italy and BOSTON, June 23, 2022 /PRNewswire=KYODO JBN/ --

 

-- 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.

 

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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