Bial to sell Parkinson drug in Europe
Bial to sell Parkinson drug in Europe
The Portuguese pharmaceutical company Bial has reached an agreement with the US company Sunovion to sell a drug which treats Parkinson in Europe.
Under the terms of the agreement “Sunovion will receive an down payment for the licence with future payments to be made following the approval for the sale of the drug. Sunovian will supply the drug apomorphine to Bial in the entire range of existing doses,” states the company in a communiqué.
Bial will be responsible for the approval process in Europe and expects to “present a European request for Authorisation for the Introduction to the Market by the end of 2021.”
The US FDA approved the Sunovion Pharmaceuticals treatment for Parkinson’s disease in 2020 which gives patients a new way to take an old drug.
The Sunovion product, Kynmobi, is a formulation of apomorphine hydrochloride, a drug that treats “off” episodes experienced by Parkinson’s patients.
These are the times when the standard of care drug, levodopa, wears off and tremors, stiffness, and other symptoms return. Apomorphine can be administered in several different ways.
The Sunovion product is the first sublingual (under tongue) formulation of apomorphine approved by the FDA.
The FDA decision for Kynmobi comes 16 months after the FDA rejected Sunovion’s initial application. The Marlborough, Massachusetts-based company resubmitted the file with more details about the product’s packaging and additional analyses of clinical data.
Approval was based on the results of a Phase 3, placebo-controlled study that enrolled 109 patients. The main goal was to show a change according a rating scale used to assess movement in Parkinson’s patients. According to results published in the UK’s The Lancet, patients who received the Sunovion drug showed an average reduction of 7.6 points on the scale compared to the average reduction reported for patients given a placebo. The drug also took effect quickly, with initial improvements observed 15 minutes after the oral film was placed under patients’ tongues.
“We are really thrilled with this agreement and to be the partner of choice for Sunovian in Europe. Bial has an ongoing compromise with Parkinson’s patients. This partnership reflects this commitment with the Parkinson community and is also an important step in our development and expansion strategy in Europe,” says António Portela, CEO of Bial.
