Neurology specialist Merz Therapeutics GmbH and its Chinese partner Jiangxi Kvvit Pharmaceutical Co Ltd on Tuesday announced an exclusive licence and collaboration agreement for INBRIJA (levodopa inhalation powder) and its proprietary inhalation device in mainland China, Hong Kong and Macao.

The agreement covers development, regulatory activities and commercialisation of INBRIJA for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease disease treated with a levodopa/dopa-decarboxylase inhibitor.

Under the terms of the agreement, Merz will supply INBRIJA and retain responsibility for global product quality and key regulatory activities, while Kvvit will lead local development, regulatory activities and commercialisation under a jointly agreed China Development Plan. Merz will receive an upfront payment, development and commercial milestone payments, as well as tiered supply and royalty arrangements linked to commercial performance, with no manufacturing rights granted to Kvvit.

INBRIJA is currently not approved in China, Hong Kong, or Macao, and any approval will depend on successful clinical development and regulatory review in the licensed territory. The inhaled levodopa therapy was approved by the US Food and Drug Administration (FDA) in 2018 and the European Medicines Agency in 2019.