Apomorphine Sublingual Film for PD

BIAL announced on 2nd September 2021 that it has entered into an agreement with Sunovion Pharmaceuticals Inc. (Sunovion) whereby BIAL received exclusive commercial license rights to commercialise apomorphine sublingual film in the European Union (EU), the European Economic Area (EEA) and the United Kingdom.

Apomorphine sublingual film (APL-130277) 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. Under the terms of the agreement, BIAL will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA). BIAL expects to submit a European marketing authorisation application for apomorphine sublingual film by the end of 2021.

As part of the agreement, Sunovion will receive an upfront payment and is entitled to receive certain milestone payments. Sunovion will supply apomorphine sublingual film in all approved dose strengths to BIAL.

António Portela, Chief Executive Officer of BIAL, said

We are pleased to be the partner of choice for Sunovion in Europe. BIAL has an ongoing commitment to Parkinson’s disease patients. This partnership reflects our commitment to the Parkinson’s community and is also an important step in our development strategy to expand BIAL’s footprint in Europe. We look forward to making this treatment option available and thus helping patients with Parkinson’s disease to cope with OFF episodes which are difficult and disabling to their lives.

Apomorphine sublingual film is approved as KYNMOBI® in the US and Canada. 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 and 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 US and Canada.

As Parkinson’s disease progresses an individual’s response to levodopa/carbidopa becomes less consistent and as a result they may spend hours a day navigating debilitating OFF episodes,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion.

Apomorphine sublingual film offers healthcare providers and patients a novel treatment option to reliably treat OFF episodes when they occur. We look forward to working with our partner BIAL to help expand access to this important on-demand treatment option for people with Parkinson’s disease across Europe.

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