China’s Tenacia Books Marinus For $266 Million To Market Seizure Med

China-based Tenacia Biotechnology is collaborating with Marinus Pharmaceuticals in a $266 million deal around ganaxolone, Marinus’ treatment for rare seizure disorders. 

Tenacia will receive the right to develop and commercialize the oral and intravenous formulations of ganaxolone in mainland China, Hong Kong, Macau, and Taiwan. The company is also on the hook for first negotiation for a future next-generation formulation or prodrug of ganaxolone. 

In return, Marinus will receive $10 million upfront and up to $256 million in development, regulatory, and commercialization milestone payments, plus tiered royalties in the low double-digits on net sales of ganaxolone in China.

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Developing Ganaxolone For Rare Seizure Disorders

The collaboration combines ganaxolone’s differentiated mechanism of action with Tenacia’s central nervous system (CNS)  expertise and development capabilities in China, said Scott Braunstein, MD, CEO of Marinus, in a statement. 

A steroid GABA receptor modulator, ganaxolone acts on a part of the brain known to have anti-seizure effects. 

An oral suspension CV of ganoxolone has been approved by the US FDA under the brand name “Ztalmy” for the treatment of seizures associated with CDKL5 deficiency disorder. CDKL5 encodes for a protein called cyclin-dependent kinase-like 5 which is critical for normal brain development. 

Besides CDKL5 deficiency, ganaxolone is being investigated in other rare seizure disorders, including a Phase 3 clinical trial in tuberous sclerosis complex and refractory status epilepticus. 

“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,” said Braunstein. 

Dr. Xiaoxiang Chen, CEO of Tenacia, expressed confidence that it is the right time to enter the market with ganaxolone, as the clinical and regulatory landscape in China continues to evolve to better support neuroscience development. 

Author

Joy Lin

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