Zambon gains exclusive rights to oral therapy IPX203 in Europe

IPX203 is experimental extended-release formulation of carbidopa, levodopa

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by Andrea Lobo |

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Zambon Biotech has entered into an exclusive deal with Amneal Pharmaceuticals for rights to seek approval and commercialize the oral treatment IPX203 for Parkinson’s disease in the European Union, U.K., and Switzerland.

IPX203 is an experimental extended-release formulation of carbidopa and levodopa, designed to ease Parkinson’s motor symptoms.

“It has been a strategic goal of Amneal to ensure that not only U.S. patients, but also Parkinson’s patients worldwide have access to our products,” Chirag and Chintu Patel, co-CEOs at Amneal, said in a press release.

“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,” they added. The financial terms of the agreement were not disclosed.

Parkinson’s disease is caused by the progressive loss of dopaminergic neurons, the nerve cells that produce dopamine, a signaling molecule involved in the control of voluntary movements. This leads to impaired dopamine signaling and ultimately causes disease symptoms.

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Levodopa used to increase dopamine levels in brain

Levodopa is the mainstay treatment for Parkinson’s, used to increase dopamine levels in the brain. It is a precursor molecule that cells use to produce dopamine and is usually given in combination with carbidopa, which prevents it from being converted into dopamine before it reaches the brain, where it is needed to ease symptoms.

However, prolonged use of levodopa may lead to periods in between doses when symptoms are not fully controlled, known as off periods. It can also cause dyskinesia, or sudden, uncontrolled movements.

IPX203 consists of immediate-release granules of carbidopa and levodopa (CD/LD), as well as extended-release beads of levodopa alone, and is designed to maintain steady levels of the molecules in the body and improve their absorption.

The therapy was evaluated in the Phase 3 RISE-PD trial (NCT03670953), which included 506 adults with advanced Parkinson’s experiencing motor fluctuations, who were enrolled at sites in the U.S. and Europe. Participants were randomly assigned to 13 weeks of treatment with either IPX203 or an immediate-release CD/LD formulation, following a dose-adjustment and transition period.

IPX203 was associated with more daily good on time, or periods when symptoms are well-controlled, and reduced off periods, compared with patients given an immediate-release carbidopa/levodopa formulation. Moreover, while the immediate-release formulation was dosed on average five times per day, IPX203 achieved benefits at an average of three daily doses.

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Trial followed by open-label extension study with 419 participants

The trial was followed by a nine-month open-label extension study (NCT03877510) that enrolled 419 patients who participated in the RISE-PD trial. This study found IPX203 remained safe and effective in controlling motor fluctuations in the long term, at a mean of three doses per day.

“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,” said Frank Weber, MD, Zambon’s CEO.

Earlier this year, Amneal also entered into an exclusive license agreement with Knight Therapeutics for rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America.

Amneal applied to the U.S. Food and Drug Administration for IPX203’s approval in 2022. In a complete response letter issued last year, the agency stated that although there is sufficient scientific evidence supporting the safety of levodopa in this combination, the same level of evidence was not established for carbidopa.

Therefore, the agency asked for more safety information before making a final decision. No concerns were cited regarding IPX203’s efficacy or its production.