Menarini Asia-Pacific Enters into an Exclusive Licensing Agreement with Astellas to Commercialize Smyraf® in Taiwan and select South-East Asian markets

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.

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Source: Menarini Asia-Pacific Enters into an Exclusive Licensing Agreement with Astellas to Commercialize Smyraf® in Taiwan and select South-East Asian markets