Date: 2017-09-13
Type of information: Licensing agreement
Compound: Validive® (clonidine mucoadhesive buccal tablet)
Company: Onxeo (France) Monopar Therapeutics (USA - IL)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism:
- alpha2-adrenergic receptor agonist. Validive® is a therapeutic application of clonidine based on the mucoadhesive technology Lauriad®. Onxeo’s proprietary Lauriad® technology significantly increases the mucous and salivary concentrations of the active ingredient it contains, with decreased systemic absorption. As an agonist of the alpha-2 adrenergic receptors, Validive® exhibits anti-inflammatory properties, and was developed for the prevention and treatment of chemoradioation therapy-induced severe oral mucositis in patients with head and neck cancer. Preclinical studies and a Phase II trial have confirmed Validive’s mechanism of action and demonstrated that the therapy significantly reduces incidence of severe mucositis, improves oral mucositisrelated symptoms and decreases radiotherapy-related adverse events, and exhibits a favorable safety profile and strong adherence to treatment.
- Validive® was granted orphan drug status in Europe in November 2011 and also received Fast-Track status from the FDA in January 2014.
Disease: severe oral mucositis induced by radiotherapy or chemotherapy in patients suffering from head and neck cancer
Details:
- • On September 13, 2017, Onxeo announced the company
has granted a global exclusive license of 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 , 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 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.
Financial terms:
- 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.
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