Orion Corporation (“Orion”) has signed a European wide marketing and distribution agreement with Marinus Pharmaceuticals, Inc. (“Marinus”) 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.
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.
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.
Satu Ahomäki, SVP Commercial Operations of Orion Corporation said: “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.”
“Orion has a strong presence across Europe in rare neurological disorders, brings an extensive commercial infrastructure and is an ideal partner to introduce ganaxolone in Europe,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “This collaboration not only serves as an important step in our global development strategy for ganaxolone, it also represents the confidence Orion has in its potential. I believe that the collaboration allows both parties to share in the long term success of ganaxolone.”
About Orion Corporation
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's net sales in 2020 amounted to EUR 1,078 million and the company had about 3,300 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.
About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year, is conducting a Phase 2 trial in tuberous sclerosis complex and has initiated a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.
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