RARE Daily

Marinus Enters Collaboration with Tenacia for Development and Commercialization Ganaxolone in China

November 17, 2022

Marinus Pharmaceuticals said that it has entered into a collaboration and supply agreement with Tenacia Biotechnology, a China-based company focused on the development of innovative treatments for central nervous system disorders, to develop and commercialize ganaxolone, its therapy for rare seizure disorders.

Photo: Scott Braunstein, CEO at Marinus

Under the terms of the agreement, Tenacia will receive exclusive rights to develop and commercialize certain formulations of ganaxolone in Mainland China, Hong Kong, Macau, and Taiwan, including the current oral and intravenous (IV) dose formulations and a right of first negotiation for a future next generation formulation or prodrug.

As part of the agreement, Marinus will receive a $10 million upfront payment and is eligible to receive up to an additional $256 million in cash milestone payments based on specific regulatory, clinical, and commercial milestones, as well as tiered low double-digit royalty payments based on net sales.

“This collaboration brings important synergies, combining ganaxolone’s differentiated mechanism of action with Tenacia’s CNS expertise and development capabilities in China to potentially expand the global reach of ganaxolone for patients with rare and debilitating seizure disorders,” said Scott Braunstein, CEO at Marinus. “Tenacia is expected to drive the development and commercialization of ganaxolone in China across our current focus areas of CDKL5 deficiency disorder, tuberous sclerosis complex, and status epilepticus, and to potentially play a key role in the development of a next generation ganaxolone formulation.”

Cyclin-dependent kinase-like 5 deficiency disorder (CDD) is a serious and rare genetic disorder characterized by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment. It’s caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. The CDKL5 gene produces a protein that is important for normal brain development and function.

Ganaxolone, marketed in the United States as Ztalmy, is the first and only FDA-approved treatment indicated specifically for seizures associated with CDD in patients two years of age and older. Ztalmy, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, is taken three times daily. It is expected to be available in July. Marinus plans to launch a comprehensive patient services program to assist with product access, ongoing support to patients, caregivers and their medical teams, and financial support to eligible patients.

Author: Rare Daily Staff

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