Business & Finance
Biosenic finalises agreement with Phebra for oral arsenic troxide development
15 January 2024 -

Biotech company BioSenic (Euronext Brussels/Paris:BIOS) and its subsidiary Medsenic SAS announced on Monday a binding term sheet with Australian pharmaceutical company Phebra Pty Ltd to adapt the terms of their existing licence agreement and marketing & distribution agreement (MDA).

The initial licence agreement, granting Medsenic SAS exclusive worldwide rights for oral arsenic trioxide (OATO) in several targeted autoimmune diseases, provided 100% net profits for Medsenic mainly in Europe and 55% net sales profit for Phebra in the rest of the world (including major markets such as the US, Canada, South America, Japan, South East Asia, China and Australia). In particular, the binding term sheet for the indication chronic Graft versus Host Disease (cGvHD) licence now provides for a royalty payment of 2% on worldwide sales, which simplifies the conditions for sublicensing to new external partners. Phebra has also agreed that Medsenic will have exclusive worldwide territorial rights for the use of OATO in GvHD.

Regarding the MDA, Phebra has agreed that the net profit allocation as stated in the initial agreement will be deleted for the sales revenues and profits generated from the sale of product, restricted to the indication cGvHD. Phebra will cover various costs, including maintaining and updating the drug substance file, ensuring compliance with regulatory requirements, updating the drug master file of OATO, managing the Contract Manufacturing Organisation (CMO), and overseeing the supply chain from active pharmaceutical ingredient to clinical product release. In recognition of these costs, the cost-of-goods for the Medsenic final clinical OATO product will be increased by a mark-up of 20%.

In addition, Medsenic will have the right to establish an Australian entity to use the OATO patents for cGvHD indication. This entity will not commercially compete with Phebra, particularly in the field of APL (acute promyelocytic leukaemia) cancer treatment, ensuring differentiation through product-specific packaging for Medsenic's GvHD treatment.