Monopar receives licence to develop Onxeo’s Validive oral mucositis treatment


Onxeo has granted a global exclusive licence to Monopar Therapeutics for its Validive (clonidine mucoadhesive buccal) tablet used to treat severe oral mucositis induced by radiotherapy or chemotherapy in patients suffering from head and neck cancer.

Onxeo is a clinical-stage biotechnology company that focuses on the development of new therapies to treat orphan diseases, particularly within oncology.

Under the deal, US-based Monopar Therapeutics will receive an exclusive worldwide licence to develop, register, produce and commercialise the therapy.

The company will also be responsible for funding all remaining development and regulatory activities, the first of which is a Phase III registration study.

"The acquisition of a Phase III-ready asset is fully aligned with our strategy to build a strong and diversified portfolio of oncology products that will improve clinical outcomes in patients with advanced cancer."

Monopar Therapeutics CEO Dr Chandler Robinson said: “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.

“We are pleased with this agreement and strongly believe in the potential of Validive to answer this large unmet need.

“The acquisition of a Phase III-ready asset is fully aligned with our strategy to build a strong and diversified portfolio of oncology products that will improve clinical outcomes in patients with advanced cancer.”

As part of the agreement, Onxeo will be entitled to an immediate $1m licence fee payment, while future milestone payments can reach up to $108m subject to the attainment of the agreed upon milestones, including $15.5m related to regulatory milestones, from Phase III to registration.