Onxeo grants a global exclusive license of Validive (clonidine mucoadhesive buccal tablet) developed to treat severe oral mucositis induced by radiotherapy or chemotherapy in patients suffering from head and neck cancer to Monopar Therapeutics.- Onxeo.

Onxeo S.A. announced the Company has granted a global exclusive license of its product Validive (clonidine mucoadhesive buccal tablet) developed for the treatment of severe oral mucositis induced by radiotherapy or chemotherapy in patients suffering from head and neck cancer to Monopar Therapeutics (Chicago, Illinois, USA), a biopharmaceutical company focused on developing innovative drug combinations to improve clinical outcomes in advanced cancer.

Following the phase II trial, the company had announced that it would not initiate the next clinical steps on its own for this asset but would actively look for an industrial partner to further its development. Under the agreement, Monopar Therapeutics Inc. receives an exclusive worldwide license to develop, register, commercialize and manufacture Validive. Monopar Therapeutics will drive and fund all remaining development and regulatory activities, the first of these activities being a phase III registration study. Onxeo is entitled to an immediate $1.0 million license fee and to future milestone payments that could reach up to $108 million subject to the achievement of the agreed upon milestones, including $15.5 million related to regulatory milestones, from phase III to registration. Escalating royalties on sales up to a 2-digit percentage are also part of the agreement.

Comment: Severe oral mucositis occurs in the majority of patients treated with radiotherapy/chemotherapy for head and neck cancer but there is no effective prevention or treatment available to date.