Assuming NNZ2591 is successful in one or more of its indications and the FDA approves availability in the US, what happens if it is used off-label for Rett or Fragile X. Who benefits (Acadia or Neuren) and would it be possible.
Reimbursement policies make off-label use of NNZ-2591 in Rett syndrome or Fragile-X extremely unlikely. NNZ-2591 will probably be priced similarly to trofinetide and how many people are likely to pay $500,000 or more per year from their own pocket? Further, health insurance companies, Medicaid and Medicare have very strict eligibility criteria, including genetic confirmation that the patient seeking reimbursement has the disorder for which the drug has been approved by the FDA.
But, in addition, Clause 11.1(f) of the 2023 JV and Licence Agreement expressly states that both parties must work to minimise any off-label use.
My second relates to the rights that Acadia holds for NNZ2591 for Rett and Fragile X - Under the agreement could Acadia sell those rights to a 3rd Party? Alternatively, if they choose not to progress with trials is there a time limit before they forfeit their rights. This may be more relevant to Fragile X
Acadia can’t sell the NNZ-2591 rights for Rett and Fragile-x (4.3). However, it may sublicense (14.1) and can assign the rights in the event of change of control of the company (29.5).
There appears to be no time limit on Acadia’s rights to NNZ-2591 in Rett and Fragile-X. But Clause 7.1 does obligate Acadia to “work in good faith to facilitate efficient and timely development of the NNZ-2591 compound and NNZ-2591 Product… in the NNZ-2591 Field and in the Territory”.
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