On September 13, 2017 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or the "Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported 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 (Press release, Onxeo, SEP 13, 2017, View Source [SID1234570545]).
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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.
"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," said Chandler D. Robinson, MD, MBA, MSc, CEO of Monopar Therapeutics Inc. "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."
Onxeo is entitled to an immediate $1.0m license fee and to future milestone payments that could reach up to $108m subject to the achievement of the agreed upon milestones, including $15.5m 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.
" It was our stated intention after its successful Phase II to partner Validive prior to initiating any remaining development steps, as it was the best strategy to maximize its value for Onxeo," said Judith Greciet, CEO of Onxeo. "This licensing transaction with Monopar Therapeutics is fully in line with this strategy and further demonstrates our capacity to execute such value-creating deals. We are pleased that Validive will get the opportunity to one day serve the unmet needs of many patients affected with severe oral mucositis, while, on our end, we are focusing all our energy on our pipeline of unique breakthrough compounds in orphan oncology."