The exclusive licensing partnership agreement provides Astellas with a total of up to €5.5m, in upfront and milestone payments, along with royalties on the net sales of Smyraf, and includes an option to extend it to select Southeast Asian markets
Menarini Asia-Pacific, a subsidiary of Italian biopharmaceutical company Menarini, has teamed up with Japan’s Astellas Pharma to develop, manufacture and market Smyraf 50mg and 100mg tablets in Taiwan.
Smyraf (peficitinib hydrobromide) is an orally administered Janus kinase (JAK) inhibitor, intended for the treatment of rheumatoid arthritis.
The drug is protected by a patent covering its composition of matter until 2032.
Under the terms of the exclusive licensing partnership agreement, Astellas is eligible to receive a total of up to €5.5m, in upfront and milestone payments.
The Japanese company is also eligible to receive royalties on the net sales of Smyraf.
Menarini holds an option to extend the partnership to select South-East Asian markets.
Menarini Asia-Pacific CEO Maurizio Luongo said: “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.”
Developed and marketed in Japan by Astellas, Smyraf has been approved in Taiwan for the treatment of rheumatoid arthritis, including the prevention of structural joint damage.
Rheumatoid arthritis is a chronic autoimmune disorder that primarily affects the joints, causing inflammation, pain, and potential joint damage.
In a separate development, the European Medicines Agency (EMA) has validated Astellas’ Type-2 variation for Xtandi to treat patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk BCR, who are ineligible for radiotherapy.
The nmHSPC is also known as non-metastatic castration-sensitive prostate cancer (nmCSPC).