Biologix announces distribution agreement with Marinus Pharmaceuticals, Inc. for ganaxolone in select markets in the Middle East and North Africa
Marinus Pharmaceuticals has entered into an exclusive distribution and supply agreement with Biologix FZCo for ganaxolone (oral suspension) in select markets in the Middle East and North Africa.
Scott Braunstein, M.D., Chairman and Chief Executive Officer, Marinus : « Our distribution agreement with Biologix for commercialisation in the Middle East and North Africa marks an important milestone in our commitment to expand the reach of ganaxoloneto help make a difference in the lives of more patients. »
About Ganaxolone
Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain. Prescription medicine ZTALMY® (ganaxolone) oral suspension is approved by the U.S. Food and Drug Administration and the European Commission for appropriate patients with CDKL5 deficiency disorder. Ganaxolone has not yet received regulatory approval in Middle Eastern and North African markets. The potential of ganaxolone is also being studied in other disorders, including in a Phase 3 trial in tuberous sclerosis complex.
US Prescribing Information for ZTALMY®(ganaxolone) oral suspension CV.
Full European Summary of Product Characteristics for ZTALMY® (ganaxolone) oral suspension is available at www.ema.europa.eu.
About CDKL5 Deficiency Disorder
CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder characterized by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment.[1]It is 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.[2]
About Biologix
Biologix FZCo a privately owned pharmaceutical company organized and existing under the laws of the United Arab Emirates (UAE), was incorporated in the Dubai Airport Free Zone in September 2002 as a regional distributor and promoter of pharmaceutical specialties in the Middle East & North Africa (MENA) countries. Biologix provides end to end services from the pre-registration phase including early access to patients, medical and disease awareness activities, registration, promotion, cold chain distribution, tender management, market access programs, pharmacovigilance and product safety, as well as the administration of risk management plans, on behalf of its partners. Biologix focuses on the following therapeutics areas: hematology-oncology, cardiology, immunology, uro-gynaecology and rare diseases.
For more information visit: www.biologixpharma.com
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA approved prescription medication ZTALMY® (ganaxolone) oral suspension CV in the U.S. in 2022 and continues to invest in the potential of ganaxolone in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings.
For more information visit www.marinuspharma.com
[1] Olson H et al. 2019 Pediatric Neurology
[2] Jakimiec M et al. 2020 Brain Sci.
