Swedish pharmaceutical company Egetis Therapeutics AB (STO:EGTX) announced on Friday that, through its subsidiary Rare Thyroid Therapeutics International AB, it has entered into an exclusive licence agreement with Fujimoto Pharmaceutical Corporation for the development and commercialisation of Emcitate (tiratricol) in Japan.

Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment.

Under the agreement, Fujimoto will hold exclusive rights for the drug's development and commercialisation in Japan, with an upfront payment and milestones totalling JPY600m (approximately SEK45m). Egetis will supply Fujimoto with semi-finished product and receive approximately one-third of the applicable income from the Japanese company.

Fujimoto will also finance the development programme for Emcitate in Japan, subject to discussions with the Pharmaceuticals and Medical Devices Agency (PMDA). As the future marketing authorisation holder (MAH), Fujimoto will handle regulatory interactions with the PMDA. This collaboration addresses the need for a local clinical trial in Japan before regulatory submissions.

Egetis plans to commercialise Emcitate in the US and Europe independently and said it is open to partnerships in other markets.

Currently in clinical trials, Emcitate has received Orphan Drug Designation from the European Medicines Agency for MCT8 deficiency. Egetis has submitted a marketing authorisation application to the EMA. The company is conducting a pivotal study (ReTRIACt) in the United States, with topline results expected in the first half of 2024, aiming for a mid-2024 rolling submission of a new drug application under the FDA's Fast-Track Designation.

(USD1=JPY151.42)