UCL Business PLC (UCLB) and the National Centre for Young People with Epilepsy (NCYPE), a specialist epilepsy charity, have signed a commercialisation agreement with Special Products Limited, a specialty pharmaceutical company focused on niche therapeutic areas, in preparation for the marketing of the Special Product's proprietary epilepsy treatment Epistatus® as a licensed medicine.
Professor Brian Neville and Dr Rod Scott from UCL's Institute of Child Health (ICH) and NCYPE have been closely involved in the development of Epistatus® since the inception of the product 10 years ago.
Special Products is currently seeking UK marketing authorisation for Epistatus®, which has been distributed internationally as an unlicensed medicine for more than 10 years on compassionate use. Epistatus®, a proprietary buccal formulation of midazolam maleate, is used to stop an epileptic seizure from developing into status epilepticus, a life-threatening condition.
Special Products filed for marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year. Once the product is approved in the UK, it is intended that the marketing authorisation will be extended to other European countries and selected world markets.
The negotiation of this agreement was supported by Dr Chris Williams, UCLB Business Manager (BioPharm), who is responsible for ICH's intellectual property. Dr Williams commented: 'We are pleased to have completed this agreement with Special Products, and look forward to seeing Epistatus® become widely available for patients as a licensed medicine.'
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