Amneal Enters into Exclusive European Licensing Agreement with Zambon Biotech for IPX203

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has entered into an exclusive licensing agreement with Zambon Biotech SA, part of the Zambon group (“Zambon”), for IPX203 in the European Union, United Kingdom, and Switzerland.

IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD) that is under review with the U.S. Food and Drug Administration. Zambon will seek regulatory approval and commercialize IPX203 in Europe. Financial terms of the agreement were not disclosed.

Zambon is a privately held multinational chemical-pharmaceutical company founded in Italy in 1906. The company continues to be managed by the family of the original founder. Zambon has extensive presence in the European neurology space, having launched and commercialized XADAGO (safinamide), which is used as add on to LD to treat fluctuating PD patients. IPX203 is expected to complement their existing portfolio and PD focus in Europe, where XADAGO is a registered trademark of Zambon SpA.

“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 U.S. 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,” said Chirag and Chintu Patel, Co-Chief Executive Officers at Amneal.

“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,” said Frank Weber, Chief Executive Officer at Zambon Biotech.

Today’s announcement of a licensing agreement with a European partner is part of Amneal’s broader strategy to bring IPX203 to Parkinson’s patients around the world. Earlier this year, Amneal also signed a license agreement with Knight Therapeutics Inc. granting exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America.

About IPX203
IPX203 is a novel, oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease. IPX203 contains immediate-release granules and extended-release coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. This formulation is distinct from RYTARY (carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the U.S. FDA in 2015.