Bial gets exclusive rights to commercialise new Parkinson’s drug in the EU and UK

  • ECO News
  • 2 September 2021

The new drug is under clinical development in Europe, so Bial will be responsible for the regulatory approvals and submissions. The Authorisation application should be submitted by the end of 2021.

Bial is bringing another Parkinson’s treatment to the European and UK markets. The company will commercialise the apomorphine sublingual film in the European Union (EU), European Economic Area (EEA) and the UK, after reaching an exclusive licensing agreement with US-based Sunovion Pharmaceuticals.

Since the treatment is still in phase 3 clinical development in Europe, BIAL “will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA),” they said in a statement. The company expects to submit a European marketing authorization application for apomorphine sublingual film by the end of the year.

In this agreement, it was settled that Sunovion “will receive an upfront payment and is entitled to receive certain milestone payments”. The US pharmaceutical company will supply apomorphine sublingual film in all approved dose strengths to Bial.

According to the Portuguese company, apomorphine sublingual film “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.”