Research & Development
Sosei reports FDA approval for APP13007 IND for first-in-human (FIH) clinical trial in the US
18 July 2019 -

Biopharmaceutical company Sosei Group Corporation (TSE:4565) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for APP13007 for the launch of a first-in-human (FIH) clinical trial in the US eye inflammation market.

This FDA approval was awarded to Formosa Pharmaceuticals Inc.

The milestone FDA approval has triggered a USD2.5m payment to Sosei Heptares from Formosa.

APP13007 was originally designed and developed at Activus Pharma Inc, formerly a wholly owned subsidiary of Sosei. Activus was divested in 2017 to Formosa, a wholly owned subsidiary of Formosa Laboratories Inc.

APP13007 is a nanoparticle formulation of the corticosteroid clobetasol in development for the treatment of post-operative inflammation of the eye.

Sosei Heptares received USD3.5m plus JPY5m in upfront cash on signing the agreement and is entitled to receive undisclosed milestone payments based on progression of Activus' pipeline as well as royalties from the commercialisation of certain products should they reach the market.