Pipeline-in-a-drug, page-161

There is a good deal of wishful thinking going on about this contract. In my respectful opinion, it means just what @baldwidx and @hottod have said it means and it has the practical effect of requiring Neuren to come to terms with Acadia on any indication for which it wishes to develop NNZ2591 in North America, other than the four for which we are presently running Phase 2 trials (one of which is paused).

The reason we will need to do a deal is that disputes are very uncertain of outcome and they are time-consuming. Any dispute that couldn't be settled by negotiation would go to arbitration, rather than a court hearing (see Clause 28), which would be much quicker. But it still takes just less than a year, on average, to get a result from an arbitration in New York. And any appeal would add another year. All of which would be running down our patent/market-exclusivity clock. It would also create a situation of open warfare with our partner. The evidence for the baldwix/Hottod interpretation (apart from simply reading the contract) is that Neuren itself has emphasised the value to it of the exemption of PM, PH, Angelmann and PW from restriction in North America. Indeed, I believe it is likely that the only reason we ended up with Acadia as our ROW partner for Trofinetide, rather than a pharma that already had a ROW structure in place, is that Acadia was in a position to give us that limited green light for North America, something no other bidder could offer.

I note in passing that I am puzzled by @LittleT's assertion that Acadia paid us AUD150m to use 2591 in Retts and Fragile X; surely much, if not most, of that sum was for the ROW rights for Trofinetide.

While on the subject of the agreement with Acadia, I observe an interesting wrinkle in relation to the PRV. Clause 15.2(a) makes careful provision for us getting one third of the value of the voucher if it is sold "or the value if not sold but used by ACADIA in connection with filing an NDA with the FDA for a product other than a Product". A similar formulation is used in 15.2(b)(ii) describing how the value would be arrived at in various circumstances, including where "or [it] is not sold to an independent Third Party and ACADIA submits it to the FDA with the corresponding NDA for any product other than a Product". But the Clause makes no provision for a payment to Neuren if Acadia uses the PRV in conjunction with an NDA for a product that is a Product. A Product is defined, in short, as anything that contains either NNZ2591 or Trofinetide as an active ingredient, whether or not in combination with anything else. This whole clause would have been easier to draft without this careful carve-out. It seems surprising that Neuren has never mentioned the possibility that Acadia may opt to use the PRV for an NDA in relation to either Trofinetide or 2591 and would not, it seems, need to pay us anything. Did they not notice? Is this why we have heard so little about it recently?

Having said all that, it remains the case that the current share price barely reflects the value to Neuren of Trofinetide alone. And, as @hottod has pointed out, we still have the four exempted indications available to us on an unrestricted basis for both North America and ROW: a market said to be five times as large as Trofinetide for Retts. And we also have unrestricted rights to any indication at all for NNZ2591 in the ROW. So none of this suggests the SP ought to be under pressure.