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- CHMP adopts positive opinion recommending EU marketing authorisation for Daybu
- If granted, Daybu would become first treatment for symptoms of Rett syndrome in EU
- Neuren would be entitled to receive US$35 million following first commercial sale in EU
Neuren Pharmaceuticals’ (ASX:NEU) partner Acadia Pharmaceuticals Inc. has received positive news for the proposed marketing of the Daybu treatment of neurobehavioral symptoms of Rett syndrome.
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure and has recommended the granting by the European Commission (EC) of a marketing authorisation for Daybu (trofinetide)
If granted, Daybu would be the first therapy approved for this indication in the EU for the treatment of adults and paediatric patients aged five years and older.
Neuren CEO, Jon Pilcher, said with no approved treatment currently available in the EU, approval of Daybu would represent an important step forward for patients, caregivers and the wider Rett syndrome community profoundly impacted by this devastating condition.
Following the CHMP recommendation, the EC will review the opinion and is expected to issue a final decision in the coming months.
If Daybu is approved, the marketing authorisation would apply to all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
Neuren has granted an exclusive worldwide licence to Acadia for the development and commercialisation of trofinetide. Under the licence agreement, for Europe, Neurenisent it led to receive US$35 million following first commercial sale, sales milestone payments of up to US$170 million on achievement of escalating annual net sales thresholds, and tiered royalties from mid-teens to low-20s% of net sales.
Rett syndrome is a rare, complex, neuro developmental disorder and occurs in approximately one of every 10,000 to 15,000 female births worldwide.
A child with Rett syndrome generally exhibits an early period of apparently normal development until six to 18 months, when many of their skills seem to slow down or stagnate.
Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. Most individuals living with Rett syndrome typically live into adulthood and require intense round-the-clock care.
NEU is steady at $12.25. Mkt cap $1.541B.
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