US-based Amneal Pharmaceuticals has signed an exclusive licencing agreement with Zambon Biotech, part of the Zambon group, for Parkinson’s disease drug IPX203.

IPX203 is an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules to treat Parkinson’s disease (PD). It is currently under review with the US Food and Drug Administration (FDA).

Under the agreement, Italy-based Zambon will seek regulatory approval and market IPX203 in the European Union, UK, and Switzerland.

The financial terms and conditions of this agreement were not disclosed.

This licencing arrangement is part of Amneal’s larger plan to make IPX203 available to Parkinson’s patients globally.

Additionally, earlier this year, Amneal Pharmaceuticals and Knight Therapeutics inked a licence agreement that gave Amneal an exclusive right to apply for regulatory clearance and launch IPX203 in Canada and Latin America.

Amneal co-chief executive officers Chirag and Chintu Patel said: “We believe IPX203 can improve the lives of the more than 10 million people worldwide living with Parkinson’s disease.

“It has been a strategic goal of Amneal to ensure that not only US patients, but also Parkinson’s patients worldwide have access to our products.

“Zambon, a family-owned business with whom we share a long-term vision and commitment toward patient communities, is the right partner to extend the reach of IPX203 to Europe.”

Zambon is a multinational chemical-pharmaceutical firm with a presence in the European neurology sector.

The company has launched and commercialised Xadago (safinamide), which is used as an add-on to LD for the treatment of fluctuating PD patients.

IPX203 is expected to complement the firm’s existing portfolio and PD focus in Europe.

Zambon Biotech CEO Frank Weber said: “Zambon Biotech’s mission is to build a long-term pipeline of innovative medicines that make patients’ lives better.

“Given our group’s capabilities in commercialization and our existing footprint in neurology, particularly Parkinson’s, we are pleased to partner with Amneal to bring IPX203 to Parkinson’s patients in Europe.”