ISU ABXIS has signed a license agreement for “Fabagal”  a therapeutic for Fabry disease, with NPO Petrovax Pharm located in Russia

◎This is their second licensing deal following the license agreement for “ISU305” an eculizumab (Soliris) biosimilar, with JSC Pharmasyntez Nord located in Russia.

ISU ABXIS(086890), an affiliate of the ISU Group (Chairman: SangBeom Kim), announced on the 26th that it has signed a license agreement for Fabagal with Russian Pharmaceutical company NPO Petrovax Pharm.

This agreement includes upfront and milestone payments, and sales royalties for the territory of Russia and all CIS countries. Under mutual agreement, further details for the deal were not disclosed at this time.

Fabagal is a therapeutic protein for the rare disease Fabry disease, and it received market approval in Korea by the Korea Ministry of Food and Drug Safety in 2014, with 35% of the current market share in Korea. Fabry disease is caused by a mutation in the gene that makes an enzyme called 'alpha-galactosidase A', which results in complex problems in various organs.

Petrovax is a leading biopharmaceutical company in Russia, established in 1996 and is among the Top-5 immunobiological pharmaceutical manufacturers in Russia. In addition, it is in the process of developing and producing a COVID-19 vaccine based on adenovirus type 5 (Ad5) with CanSino, a Chinese company specializing in vaccine development. ISU ABXIS is currently working in the CMO business including vaccine production, and additional synergy between these companies is possible in the future.

An official from ISU ABXIS said, “This is our second deal since the license agreement for ISU305, a biosimilar of Soliris, with the Russian pharmaceutical company JSC Pharmasyntez-Nord in 2020. We are continuing to broaden the global market for Fabagal”.

He also added, “With the expanding recognition of our reputation among the biopharma companies in Russia and our highly skilled in-house capabilities, we will accelerate our progress in becoming a CMO for the Sputnik vaccine production”.

ISU ABXIS has been in discussion with the institution in charge of transferring Sputnik vaccine technology from the Russian Direct Investment Fund (RDIF). Several executives are planning to visit Russia in person for in-depth discussions to expedite the commencement of the business.