“Neuren is in a far stronger position following the partnership with ACADIA Pharmaceuticals announced today. It makes a very significant and immediate difference in our ability to complete the development of trofinetide for patients in North America and around the world. Importantly, Neuren now has its lead program fully funded, we have access to ACADIA's broad range of capabilities in the US and we have secured significant participation in the potential value of trofinetide in North America, as well as retaining the future value of both trofinetide outside North America and NNZ-2591.“
Capabilities and funding secured to get trofinetide to market
Exclusive license to ACADIA for North America, Neuren retains all rights outside
North America
Neuren to receive up to US$465 million plus royalties plus share of value of Rare Pediatric Disease Voucher if awarded
ACADIA provides the strong capabilities and resources required to execute and fund Rett syndrome Phase 3 trial, commencing in H2 2019 following completion of manufacturing activities
All data and regulatory documents may be freely used by Neuren outside North America
Neuren now in a position to advance NNZ-2591
Demonstrated efficacy in models of Parkinson’s disease, stroke, traumatic brain injury, peripheral neuropathy, Fragile X syndrome, memory impairment and multiple sclerosis
Neuren now has funds to accelerate development
Demonstrated efficacy in pre-clinical models of Parkinson’s disease, stroke, traumatic brain injury, peripheral neuropathy, Fragile X syndrome, memory impairment and multiple sclerosis
Funds now available to accelerate CMC and pre-clinical development required prior to clinical trials
Issued composition of matter patents in US, Japan and all EPO countries except Turkey
Expire 2024, potential to extend to 2029
Method of treatment patents and applications for NNZ-2591
Issued US patent for autism spectrum disorders and neurodevelopmental disorders and pending applications in Europe and Japan – expire 2034
3 issued US patents for Parkinson’s, peripheral neuropathy and cognitive impairment – expire 2024
Actively support ACADIA in development of trofinetide in North America
US Phase 3 program in Rett syndrome Fragile X syndrome development plan
Advance Neuren’s strategy to develop and commercialise trofinetide outside North America
Engage with regulatory authorities to confirm any additional requirements beyond US data for registration in Rett syndrome
Accelerate development of NNZ-2591
Advance CMC and toxicology studies to enable clinical trials Confirm indication strategy to maximise value worldwide
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