Merz Therapeutics GmbH and Jiangxi Kvvit Pharmaceutical have entered into an exclusive license and collaboration agreement regarding INBRIJA (levodopa inhalation powder) and its proprietary inhalation device for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s Disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor in mainland China, Hong Kong and Macao.?

Under the agreement, Merz will supply INBRIJA and retain responsibility for global product quality and key regulatory activities. Kvvit will lead development, regulatory activities and commercialisation in the licensed territory under a jointly agreed China Development Plan. Merz will act as Overseas Holder of the Drug Registration Certificate and Kvvit will serve as Domestic Responsible Person, funding local clinical development and regulatory submissions.? INBRIJA is currently not approved in China, Hong Kong and Macao, and any potential approval will depend on successful clinical development and regulatory review in the licensed territory.

Andrea von der Lippe, President, Region International Markets, said, “We are pleased to partner with Kvvit to potentially bring INBRIJA to people living with Parkinson’s disease in Greater China. Kvvit’s local development and commercial capabilities, combined with Merz’s experience with INBRIJA, create a strong foundation to expand access to an additional treatment option for patients experiencing OFF episodes.”

Yang Lizhen, VP, Jiangxi Kvvit Pharmaceutical, said, “Kvvit is always committed to providing outstanding services for human health. Based in China and with a global perspective, it hopes to offer patients more valuable and innovative treatment plans for neurological diseases. Based on this cooperation opportunity with Merz for the development, registration and subsequent commercialisation of INBRIJA, we will closely cooperate with medical professionals to facilitate its rational application in clinical practice.”

Under the agreement, Merz Therapeutics will receive an upfront payment, in addition to development and commercial milestone payments, as well as tiered supply and royalty arrangements linked to commercial performance in the territory.