Medsenic, BioSenic’s subsidiary, signed a new set of licensing and commercialization agreements with Phebra PTY Ltd.

BioSenic
BioSenic

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PRESS RELEASE – PRIVILEGED INFORMATION

The adapted supply and commercialization conditions to better achieve the development of the first oral formulation of arsenic trioxide for the treatment of cGvHD should provide the best chances for final market access.

Mont-Saint-Guibert, Belgium, July 2, 2024, 7.00am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, and its subsidiary Medsenic SAS, today announce the signature of global licensing, supply and commercialization agreements with Phebra Pty Ltd. related to the adaptation of the License Agreement and the MDA signed earlier in May 2021, when Phebra became a minority shareholder in Medsenic SAS. The improved terms will make it more attractive for investors to participate in the financing of the upcoming Phase 3 trial of oral arsenic trioxide (OATO/ ArsciCor). This new licensing agreements between Medsenic SAS and Phebra Pty Ltd should facilitate the final steps of manufacturing, clinical confirmation of efficacy and subsequent commercialization of our oral arsenic drug in the field of chronic Graft versus Host Disease (cGvHD).

The existing License Agreement has been updated and provides a balanced set of terms best suited for the optimal drug manufacturing, clinical development and future commercialization of our oral arsenic trioxide medication (OATO/ArsciCor), all adapted to the sole indication of cGvHD. The license provides for a royalty on worldwide sales to Phebra, which simplifies and facilitates the terms and conditions for possible sublicensing to future external partners. In addition, under the license agreement, Phebra Pty Ltd. agrees that Medsenic SAS will have exclusive worldwide territorial rights for the use of OATO in GvHD. Commercial arrangements for other indications in the initial Licence Agreement remain unchanged.

With respect to the Supply and Commercialization Agreements, Phebra Pty Ltd. remains responsible for maintaining and updating the drug substance file to comply with the regulation of all active territories; of controlling the compliance with various regulatory authorities on ongoing supplier approval and compliance with Good Manufacturing Practices (GMP) requirements; of updating the drug master file of OATO; of managing the Contract Manufacturing Organization (CMO) and supply chain of the active pharmaceutical ingredient for the clinical release of the product; and of covering the regulatory and quality and GMP expenses.

In addition, Medsenic will have the right to establish an Australian entity to use the OATO patents for the cGvHD indication. The Australian entity will not commercially compete with Phebra Pty Ltd., particularly in the field of APL (acute promyelocytic leukemia) cancer treatment, by producing Medsenic's GvHD treatment in indication-specific packaging.