BIOSENIC (Euronext Brussels and Paris: BIOS), a clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, and its subsidiary Medsenic SAS, have announced the signing of a binding term sheet with Phebra PTY Ltd. This pertains to the adaptation of the License Agreement and the MDA signed in May 2021.

The initial License Agreement outlined a commercialization agreement, granting 100% net profits for Medsenic SAS primarily in Europe and 55% net sales profit for Phebra PTY Ltd. in the rest of the world, encompassing major markets such as the US, Canada, South America, Japan, Southeast Asia, China, and Australia. Specifically, the binding term sheet for the chronic Graft versus Host Disease (cGvHD) license now stipulates a royalty payment of 2% on worldwide sales, simplifying conditions for offering sublicenses to new external partners. Additionally, under the license agreement, Phebra PTY Ltd. agrees that Medsenic SAS will hold exclusive worldwide territorial rights for the use of OATO in GvHD.

Concerning the MDA, Phebra PTY Ltd. consents to the deletion of the net profit allocation, as stated in the initial MDA, for the sales revenues and profits generated from the product's sale, restricted to the cGvHD indication. Phebra PTY Ltd. also commits to covering various costs, including maintaining and updating the drug substance file, ensuring compliance with regulatory requirements in active territories, ongoing supplier approval, compliance with Good Manufacturing Practices (GMP), updating the drug master file of OATO, managing the Contract Manufacturing Organization (CMO) and supply chain, and covering regulatory, quality, and GMP expenses. To account for these costs, the cost-of-goods for Medsenic's final clinical OATO product will see a mark-up of 20%.

Moreover, Medsenic gains the right to establish an Australian entity to utilize the OATO patents for the cGvHD indication. This entity will not engage in commercial competition with Phebra PTY Ltd., particularly in the field of APL (acute promyelocytic leukemia) cancer treatment, ensuring that Medsenic's GvHD treatment is produced in product-specific packaging.

Prof. François Rieger, President of the Board and CEO of the BioSenic Group, stated, "Our collaboration and partnership with Phebra PTY Ltd., a long-term minority shareholder in our group, now result in an agreement on the licensing and commercialization of the oral formulation of our lead product, ATO. This agreement is highly favorable for the smooth development and increased interest of new investors to help make our lead project a success." He emphasized the goal of providing patients with Graft versus Host Disease a critical therapeutic solution and highlighted the importance of a successful cGvHD development program for the company's overall success. Prof. Rieger also acknowledged parallel efforts in developing new indications/therapeutic applications for innovative formulations of ATO and optimizing/licensing other earlier technologies, particularly related to the cell repair platform using GMP mesenchymal stem cells, which could add significant value.

 

Source: globenewswire.com

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