Menarini Signs Exclusive License Agreement with Astellas

Menarini Asia-Pacific has entered into a long-term exclusive licensing agreement with Astellas Pharma Inc. (Astellas) for the development, manufacturing and commercialization of Smyraf® 50 mg and 100 mg Tablets (generic name: peficitinib hydrobromide), an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, in Taiwan. Smyraf® is approved in Taiwan and has patent protection for the composition of matter until 2032.     Under the terms of the agreement, Astellas will receive payments of up to EUR 5.5 million in total, including upfront and milestone payments. In addition, Menarini will pay Astellas a high single-digit percentage royalty on net sales of Smyraf®. Menarini will have an option to expand its rights to certain Southeast Asian markets.   Smyraf® was developed by Astellas and is currently marketed in Japan, indicated for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients with inadequate response to conventional therapy.   Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects the joints, causing inflammation, pain and potential joint damage. With an estimated prevalence of 287.0 per 100,000 people in Taiwan[1], rheumatoid arthritis is recognized as a significant health problem and efforts are being made to improve diagnosis, treatment and management in the region amid an aging population.   Maurizio Luongo, Chief Executive Officer of Menarini Asia-Pacific, said: "Menarini has a long history as a preferred partner for many biopharmaceutical companies in the Asia-Pacific region, and we are excited that Astellas has entrusted Menarini to introduce and commercialize Smyraf®. Patients suffering from rheumatoid arthritis often need different options when treatment targets are not achieved. With its proven efficacy and flexible dosing advantages, Smyraf® will play an important role in this regard."   [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)}. https://vizhub.healthdata.org/gbd-results/   Source