Neurim Pharmaceuticals Paediatric Prolonged-Release Melatonin (“PedPRM”) to be Marketed by Biocodex in France

Tel Aviv, Israel, March 13, 2017

Neurim Pharmaceuticals (“Neurim”) announced today that it has entered into a licensing agreement with Biocodex. The agreement grants Biocodex exclusive marketing rights for Neurim’s new Rx PedPRM in France.

Neurim’s age-appropriate drug is targeted to treat sleep disorders in children with autism spectrum disorders (ASD) and neurogenetic diseases. It is expected to be the first sleep drug approved for children.

Biocodex promotes Circadin®, prolonged-release melatonin 2mg indicated to treat primary insomnia in the elderly, since 2013 in France. “Biocodex played a significant role in obtaining reimbursement for Circadin under a Temporary Recommendation for Use (RTU) for treating sleep disorders in children with neurodevelopmental disorders. It was only natural that the collaboration will deepen to include PedPRM.” Said Sharon Elkobi, VP Business Development of Neurim Pharmaceuticals. “Additional agreements are expected to follow in order to make the new treatment accessible for children and their families”.

“Sleep disturbances in children presenting with neurodevelopment disabilities represent an unresolved therapeutic challenge. In addition to Circadin® for the treatment of primary insomnia in adults, Biocodex is pleased to expand its productive partnership with Neurim and is proud to continue the work being done on the RTU in order to make this new promising product available for these children in France.” said Paul Bernasconi, MD, Vice President France Operations of Biocodex.

About PedPRM

PedPRM is a response to an unmet clinical need in the field of paediatric insomnia, specifically developed to address main concerns in children with ASD and neurogenetic diseases. PedPRM is an age-appropriate formulation designed for populations with swallowing difficulties.

PedPRM has recently completed a Phase III study, under EU-PIP and US-FDA IND, showing positive top-line results. The drug met the primary efficacy endpoint demonstrating statistically significant improvement in total sleep time (TST) compared to placebo. Secondary efficacy endpoints demonstrating improvements in sleep initiation and maintenance were met as well.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals Ltd. is a neuroscience drug discovery and development company. Its first approved drug Circadin® is commercially available in Europe, Asia-Pacific, Latin America, Africa and the Middle East.

The company has a strong and innovative product pipeline intended for insomnia, Alzheimer’s disease, dementia, glaucoma and pain.


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