Portuguese Bial will commercialise a new drug for Parkinson's disease, which will reinforce the company's presence in Europe. The drug is expected to arrive in 2023.
Bial will take another step in the treatment of Parkinson’s disease, with the commercialisation of a new drug to fight the disease. Speaking to ECO, the company’s CEO noted that this is another step in the path of neurology, hoping that the new drug may be available by 2023.
At stake is the apomorphine sublingual film, which will be commercialised in the European Union (EU), European Economic Area (EEA) and the United Kingdom. Bial has reached an exclusive licensing agreement with US-based Sunovion Pharmaceuticals and, given that in Europe the treatment is still in phase 3 clinical development, Bial “will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA),” as explained in a statement released this week.
Speaking to ECO, António Portela explains that, “over the last decade”, Bial has built its presence in Europe “based on the launch of two central nervous system drugs” developed by itself. “We have made an enormous investment to set up a very competent structure that addresses neurology in Europe,” says the CEO.
Thus, with the commercialisation of this new drug, Bial will “strengthen its presence as a leading pharmaceutical company in neurology in Europe.”
António Portela tells ECO that he hopes to submit a European marketing authorization application for apomorphine sublingual film by the end of the year. “Within the normal deadlines, we will be able to start commercialising this new medicine in 2023,” he adds.
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.”