MARLBOROUGH, Mass.– Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has entered into an agreement with BIAL in which Sunovion has granted exclusive commercial license rights in Europe for apomorphine sublingual film (APL-130277). APL-130277, approved as KYNMOBI® (apomorphine hydrochloride) sublingual film in the U.S. and Canada, is a novel thin film formulation of apomorphine that dissolves under the tongue for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). APL-130277 is currently in Phase 3 clinical development in Europe.
By 2030, an estimated 10 million people worldwide will be living with PD.1 OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. These episodes may disrupt a person’s ability to perform everyday activities and are characterized, in part, by tremor, stiffness, slowed movement or other symptoms.
Under the terms of the agreement, BIAL will be responsible for submitting marketing applications consistent with marketing authorization procedures in Europe and have exclusive commercial rights to distribute and commercialize apomorphine sublingual film in the European Union (EU), the European Economic Area (EEA) as well as the United Kingdom. BIAL expects to submit a European marketing authorization application for apomorphine sublingual film by the end of 2021. Sunovion will receive an upfront payment and is entitled to receive certain milestone payments. Sunovion will supply KYNMOBI in all approved dose strengths to BIAL.
Sunovion continues to hold the exclusive commercial rights to KYNMOBI in North America and all other regions of the world outside of the EU, EEA as well as the United Kingdom. KYNMOBI is the first and only sublingual (under the tongue) therapy available for the on-demand treatment of PD OFF episodes in the U.S. and Canada.
