<If I were running the outfit, I would approach VCs with the simple pitch to secure funds to bring ampakines into the clinic for the most easily accessible indication, probably post operative RD. If/when it gains approval for that indication, move towards a partnership that incorporates ampakines in one of the many pain management formulations that are being used by millions. That's a big payday, and it's not that hard. Efficacy is established, and the market is huge.>
Enemem:
You don't think this was tried? For the most part, VCs are not interested in this kind of opportunity. Why? They want to know whether the exits are, and how much it would cost to get there. We think efficacy has been proven, but it hasn't, not by their standards. Cortex has what I call HOC--Hint of Concept. The quickest exit used to be post-Phase IIa data, now it is post-PhIIb. To get there you'd need to run a couple (in different populations, including elderly) larger PhII trials. Even run as a near-virtual operation, this would take a couple of years, costing at least $20 million. In 2012, there were just four VC/private investor CNS fundings that were $20 million or above: TauRx, which tapped its Singapore investors again for a Phase III in Alzheimer's; Naurex, which raised $38 million to run PhIIb and beyond with its rapid-acting antidepressant (the biggest story of 2012); Collegium, doing reformulations; Marinus, running PhII trials in multiple disorders with ganaxolone, which has considerable PhII data already. Of this group, only Marinus is a relevant comp, so it's not like this is easily and frequently done.
To get through your benchmark of PhIII and 'approval', figure another $40-50 million at minimum. Particularly with the legacy of Lilly's failure in this area, VCs are not going to be easily convinced that new investors will be available after PhIIb for an Ampakine in an indication that has no established regulatory path to approval.
Which is why I hoped a Pharma--one with a pain program agenda--would step in. VCs are very unlikely. Varney tapped whatever VC connections he had, and couldnt get anything. The unknown variable is whether Lippa et al have other VC/investor connections who might be convinced to do that $20 million first tranche.
As to the ex-UC license strategy: Gfp used to have notes regarding patent expirations:perhaps the new group sees some critical IP as reaching the end of its shelf-life, allowing them to operate without a license. It's not like anyone else is going to bother.
<<That's a big payday, and it's not that hard>>
People with money are not at all sure of the former, and certainly don't believe the latter.
NP
