A. Menarini Asia-Pacific Holdings Pte Ltd.

The EC’s decision comes after the EMA’s Committee for Medicinal Products for Human Use provided a positive opinion recommending approval for Orserdu. Credit: ORION PRODUCTION/Shutterstock.com. The European Commission (EC) has granted approval for the Menarini Group’s Orserdu (elacestrant) to treat patients with estrogen receptor (ER)‑positive , HER2-negative, locally advanced or metastatic breast cancer (mBC). Orserdu received the approval as a monotherapy for usage in postmenopausal women and men with tumours carrying an activating ESR1 mutation. Recommended Reports Reports LOA and PTSR Model - Camrelizumab in Breast Cancer GlobalData Reports LOA and PTSR Model - Enzalutamide in Breast Cancer GlobalData View all Companies Intelligence Astellas Pharma Inc Menarini Asia-Pacific Pte Ltd Menarini C H M P INC Soc Co Ltd View all These patients also should have progressed after treatment with a minimum of one line of endocrine therapy such as a CDK 4/6 inhibitor to be eligible to receive Orserdu. The EC’s decision comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion in July 2023 recommending a grant of approval for the therapy. Based on findings from the Phase III EMERALD clinical trial, the EC granted approval for Orserdu in this indication. Trial data showed that treatment with elacestrant offered statistically significant progression-free survival (PFS) compared with standard-of-care treatment with an approved endocrine monotherapy of the investigator’s preference. In patients whose tumours had ESR1 mutations, elacestrant offered a median PFS of 3.8 months compared with 1.9 months following treatment with SOC. Elacestrant also cut down the disease progression or mortality risk by 45% versus SOC. The Menarini Group CEO Elcin Barker Ergun said: “We have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them. “We are proud of delivering a new breast cancer treatment that offers efficacy in a once-daily pill and represents the first innovation in endocrine therapy in nearly two decades; we are also incredibly grateful for the support of the oncology researchers and all the patients who participated in the clinical studies that made today’s achievement possible.” Menarini Asia-Pacific recently signed a deal to license Astellas Pharma ’s Smyraf for rheumatoid arthritis treatment.

SINGAPORE, Sept. 13, 2023 /PRNewswire/ -- Menarini Asia-Pacific has entered into a long-term exclusive licensing partnership with Astellas Pharma Inc. (Astellas) for the development, manufacturing and commercialization of the orally administered Janus kinase (JAK) inhibitor Smyraf® 50 mg and 100 mg Tablets (generic name: peficitinib hydrobromide) in Taiwan for the treatment of rheumatoid arthritis. Smyraf® has been approved in Taiwan and has patent protection for composition of matter until 2032. Subject to the terms of the agreement, Astellas will receive total payments of up to €5.5 million including upfront and milestone payments. In addition, Menarini will pay Astellas a high-single digit percentage royalties on net sales of Smyraf®. Menarini will have an option to extend the rights to select South-East Asian markets. Smyraf® was developed and is currently marketed in Japan by Astellas and is indicated for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapies. Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects the joints, causing inflammation, pain, and potential joint damage. With an estimated prevalence of 287.0 per 100,000 persons in Taiwan[1], rheumatoid arthritis is acknowledged as a significant health problem, and efforts are being made to enhance its diagnosis, treatment, and management amidst an ageing population in the region. "Menarini has a long history as the partner of choice for many biopharmaceutical companies across the Asia-Pacific region and we are excited that Astellas has trusted Menarini to promote and commercialize Smyraf®. Patients suffering from rheumatoid arthritis often need different options if the treatment target is not achieved. With proven efficacy and flexible dosing benefits, Smyraf® will play an important role in this regard," said Maurizio Luongo, Chief Executive Officer of Menarini Asia-Pacific. [1]{Global Burden of Disease Collaborative Network}. 2020. Global Burden of Disease Study 2019 (GBD 2019) Results. Seattle. USA. {Institute for Health Metrics and Evaluation (IHME)}. / About Menarini Asia-Pacific Menarini Asia-Pacific is a member of the Menarini Group, the world's largest Italian biopharmaceutical company with a heritage of over 130 years and over 17,000 employees in more than 140 countries. Here in Asia-Pacific, Menarini's vision is to be a leading provider of important healthcare brands to improve the lives of people in the region. Menarini Asia-Pacific operates across the entire commercial value chain, from clinical development, regulatory approval, and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Consumer Health, Dermatology, Allergy/Respiratory, Gastroenterology, Cardio-metabolic, Anti-infectives, Oncology/Specialty Care and Men's Health. For the Financial Year 2022, the Menarini Group's revenue registered 4.15 billion euros, of which the Asia Pacific region has grown to become a dynamic engine of growth for the Group with more than 10% revenue contribution. For more information, visit Logo - SOURCE Menarini Asia-Pacific