Orion Corporation has signed a European wide marketing and distribution agreement with Marinus Pharmaceuticals for ganaxolone, a GABAA receptor modulator being investigated in multiple rare seizure disorders.
Under the terms of the agreement, Orion will have the right to sell and market ganaxolone in Europe. Orion has made an upfront payment of EUR 25 million to Marinus as a signing fee. Marinus is also eligible to receive tiered royalty ranging from low double-digits to low twenties on Orion’s future sales. In addition, Marinus is eligible to receive milestone payments upon achievement of certain development and commercialisation milestones.
“Orion has made an upfront payment of EUR 25 million to Marinus as a signing fee.”
Marinus will be the marketing authorisation holder and responsible for current and future clinical trials of ganaxolone. Orion will be responsible for market access in all 30 countries comprising the European Economic Area (EEA) as well as in the United Kingdom and Switzerland.
“We are pleased to be the partner of choice for Marinus in Europe. What we have seen so far with ganaxolone is encouraging and signifies an ongoing commitment to the rare epilepsy communities. I look forward to these efforts to advance effective medicines for these disorders. Ganaxolone could be a promising treatment option for patients suffering from rare epilepsies,” says Satu Ahomäki, SVP Commercial Operations of Orion Corporation.
Positive phase III data
In September 2020, Marinus reported positive phase III data from a study that evaluated orally administered ganaxolone for the treatment of seizures in children and young adults with Cyclin-dependent Kinase-like 5 (CDKL5) deficiency disorder (CDD). Based on the study results, Marinus submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for ganaxolone in CDD and expects to file a marketing authorisation application (MAA) with the European Medicines Agency (EMA) later this year. Both agencies have granted orphan drug designation to ganaxolone for the treatment of CDD.
In addition to CDD, orally administered ganaxolone is being investigated for the treatment of seizures associated with tuberous sclerosis complex (TSC) and intravenously administered ganaxolone is being investigated for the treatment of seizures associated with refractory status epilepticus (RSE). Marinus is also looking into additional indications and patient populations that could benefit from ganaxolone.
Photo of Satu Ahomäki