Replies to post #38904 on RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Enemem, >>> where they are planning on taking this IP? <<<



Since the Ampakine and Dronabinol licenses have both been terminated, does Cortex currently have any IP (?)

After raising some money, Cortex might be able to restore the licenses, but of the Ampakine license, Lippa dismissively says - "The Company does not believe this license agreement is material or necessary for its drug development plan".

In contrast, after the termination of the Dronabinol license in March, Lippa immediately leapt into action -- >>> "On the same date as the receipt of the termination letter, newly appointed officers of the Company initiated discussions with the University of Illinois regarding the possibility of extending the cure period or otherwise amending the License Agreement." <<<

So the impression one gets is that Lippa doesn't care one whit about Ampakines, but is actively trying to renegotiate a license agreement for Dronabinal with the Univ of Illinois. So if Cortex does manage to continue, it will likely be with Dronabinol, and Ampakines will be shelved or disposed of. Hopefully whoever ends up with the Ampakines will ultimately do something with them.





>>> Item 1.02. Termination of a Material Definitive Agreement
On March 22, 2013, the Company received a letter from the University of Illinois indicating that the license agreement entered into on October 10, 2007 between the University of Illinois and Pier Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company (as amended, the "License Agreement"), had been terminated on March 21, 2013. Pier Pharmaceuticals Inc., named SteadySleep RX Co. at the time the License Agreement was entered into, was acquired by the Company in a merger announced on August 16, 2012. On February 19, 2013, the University of Illinois had notified the Company of a default under the Licence Agreement due to non-payment of a $75,000 milestone fee due December 31, 2012. Under the terms of the License Agreement, the Company had 30 days to cure the default, which it did not do. On the same date as the receipt of the termination letter, newly appointed officers of the Company initiated discussions with the University of Illinois regarding the possibility of extending the cure period or otherwise amending the License Agreement. On April 1, 2013, after considering the Company's proposals, the University of Illinois informed the Company that, while it believed the the License Agreement was terminated, it remained open to negotiating a new license agreement. Accordingly, the Company and the University of Illinois currently are in discussions regarding the terms of a new license. Regardless of whether such new license agreement is reached, due to its rights of inventorship and independent of the License Agreement, the Company remains free to practice additional patents and patent applications describing a dosage range for the use of dronabinol in the treatment of sleep apnea, as well as for various formulations of dronabinol.

The License Agreement contained, among other provisions, the right to practice certain patents and patent applications in the United States and other countries claiming the use of certain compounds commonly referred to as dronabinol for the treatment of sleep apnea, and granted exclusive rights (i) to use the patent rights, as defined in the agreement, that were then held by the University of Illinois with respect to dronabinol, (ii) to identify, develop, make, have made, import, export, lease, sell, have sold or offer for sale any related licensed products, and (iii) to grant sublicenses of the rights granted in the License Agreement, subject to the provisions of the License Agreement. In exchange, the License Agreement required the payment to the University of Illinois of a license fee, royalties, patent costs, and certain milestone payments laid out by schedule, including the $75,000 fee described above, as well as granting the University of Illinois 100,000 shares of equity securities of SteadySleep RX Co. <<<


http://biz.yahoo.com/e/130405/corx8-k.html

[neuroinv]

<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