BioSenic, a subsidiary of Medsenic, released updated terms for its licensing agreement with Phebra, an Australian contract manufacturing and development organisation, for the advancement of its oral arsenic trioxide therapy.

Medsenic first signed a commercial agreement allocating itself 100% net profits mainly in Europe and 55% net sales profit for Phebra in all other countries in May 2021. However, the adapted binding term sheet for chronic Graft versus Host Disease (cGvHD) now gives BioSenic a royalty payment of 2% on worldwide sales and exclusive worldwide territorial rights for the therapy’s use in GvHD. As per the 15 January press release, the changes should make it easier to offer sublicenses to new external partners.

In the new deal, Phebra took on the responsibility of covering the costs of maintaining and updating the drug substance file to keep up with regulatory requirements in active territories. This includes maintaining its manufacturing standards according to Good Manufacturing Practices (GMP) requirements, managing the contract manufacturing organisation (CMO) and supply chain for all parts of drug development and more.

Due to these additional duties, Medsenic agreed to pay Phebra 20% more for the cost-of-goods. Furthermore, the updated deal offered Medsenic the option to form an Australian entity to use the oral arsenic trioxide patents for cGvHD, ensuring there would be no commercial competition with Phebra.

The initial contract terms outlined plans to run a clinical study investigating Phebra’s oral formulation of arsenic trioxide, stating that if it had not commenced by 31 May 2023, Phebra could legally exit the deal unless both parties agreed to postpone the study date. Reaching the agreed upon date, Medsenic still had not begun the study, so the license agreement grant has been updated, now dependent on Medsenic’s ability to intiate the clinical study before 31 May 2024. Before the licensing agreement, Phebra was a long-term minority shareholder of Medsenic.

In a 15 January press release, Professor François Rieger, CEO of the BioSenic Group, said, “the radical improvement in the commercial agreement between Phebra and Medsenic should facilitate our task of implementing all the necessary funding for the few years of the cGvHD Phase 3 trial.”