IPX203 is intended to treat Parkinson’s disease. Credit: Orawan Pattarawimonchai / Shutterstock.com.

Amneal Pharmaceuticals has signed an exclusive licensing agreement with Zambon Biotech, granting the latter rights to commercialise IPX203 for the treatment of Parkinson’s disease (PD) in several regions, including the European Union, the UK and Switzerland.

An oral formulation of carbidopa / levodopa (CD/LD) extended-release capsules, IPX203 is being reviewed by the US Food and Drug Administration.

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Zambon will seek regulatory approval and subsequently market the therapy.

Zambon, leveraging its presence in the European neurology market, aims to enhance its PD product portfolio with IPX203.

The company has a history of launching and marketing neurology therapies, including XADAGO (safinamide), a supplementary therapy to LD for managing fluctuating PD.

The licensing agreement is a strategic move by Amneal to extend the reach of IPX203 to PD patients globally.

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This follows a similar agreement in early 2024 with Knight Therapeutics for the rights to IPX203 in Canada and Latin America.

The therapy has immediate-release granules and extended-release coated beads. These granules contain CD, LD and a disintegrant polymer, ensuring rapid dissolution.

The extended-release beads are coated with a sustained-release polymer and a mucoadhesive polymer, maintaining the granules’ adherence to the absorption area for an extended period.

An enteric coating protects the granules from premature disintegration in the stomach.

This formulation distinguishes IPX203 from RYTARY, another extended-release CD/LD treatment for PD by Amneal, approved by the US FDA in 2015.

Zambon Biotech CEO Frank Weber stated: “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 commercialisation 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.”