Maintenance of the license is now subject to the launch of the OATO Phase III before May 2024 instead of 31 May 2023


Parties also currently negotiating a potential renegotiation of the other licensing terms. (Credit: Cytonn Photography on Unsplash)

BioSenic, the clinical stage company specializing in serious autoimmune and inflammatory diseases and cell repair, today announces the amendment of the license agreement between its affiliate Medsenic SAS and Phebra Pty Ltd, the leading Australian developer, manufacturer and supplier of high quality and innovative pharmaceuticals.

In May 2021, Medsenic and Phebra entered into a license agreement and a marketing and supply agreement for the oral formulation of arsenic trioxide (OATO) in the following indications: Graft Versus Host Disease (GvHD), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus 151 (SLE), infectious diseases related to COVID-19 and CNS inflammatory diseases related to Multiple Sclerosis.

Under the license agreement, Medsenic agreed to commence a clinical study using Phebra OATO. If such study would not start before 31 May 2023, Phebra could terminate the license agreement unless the parties agree to postpone such date. The license agreement grant is now subject to Medsenic’s ability to commence a clinical study using OATO before 31 May 2024.

In addition, BioSenic Group and Phebra are currently analyzing the possibility to extend the Medsenic Territories and the commercial terms thereof.

“We are particularly satisfied of the excellent degree of coordination between Phebra and Medsenic, aimed at delivering the clinical batches for entering into the realization of the expected Phase 3 trial of the oral medication, related to the previously agreed on exclusive license between Phebra and Medsenic,” said Prof. François Rieger, PhD, Chairman and Chief Executive Officer of BioSenic. “Both recent technical advances for the oral ATO clinical supply and the newly agreed amendment to the original license will help render possible a quick FDA approval, through a necessary IND submission, followed by the expected activation of centers and patients recruitment.”

Source: Company Press Release