Epicept - Bob Cook

2010-01-30 10:55, Edited at: 2010-06-11 12:41

Fick svar av Bob på Epicept

Mina frågor:

_Hi Robert,

I wanted to raise some questions and hopes that my information regarding the Swedish AML guidelines were helpful.

I have mailed Endo regarding how they are going to proceed with Lidopain and Lidoderm and received no answers, have you a better insight of how this partnership and more importantly agreement including substantial amount of milestone payments are progressing? If there is no development regarding Lidopain is Endo\'s actions regarded as a breach of contract? What actions would that lead to?

I have also mailed GNI and Shanghai Genomics regarding how their IND application is developing for EP-1013 and received no answers from them either. Have you information or a preliminary timetable on this? Are they still working on the IND application or have the financial crises cut back on their development process?

I have also mailed Myriad Pharma regarding when they will finish their phase II a/b of Azixa and hoped to hear some news regarding a progression into phase III. No answers from them either. I first heard that the final results of phase IIb will be presented during this spring, but nothing more specific and seemingly un-confirmed. Also I have looked over the agreement with Myriad and see a total of 27 MUSD will be paid upon achievement of all milestones. How much have Epicept yet to receive from Myriad?

The last question regards Crinobulin and the initiation of a phase Ib study that was announced to start in the second half of 2009. I have not seen that it has started or any other communication that it has been delayed?

Keep up the good work, great news yesterday by the way, should boost the price of NP-1 substantially

Sincerely ###_

Svar från Bob:

We have no information to provide as to Endo’s progress with Lidoderm for backpain. The next milestone that is payable is upon acceptance by the FDA of a sNDA seeking approval for a backpain indication for Lidoderm. We do not have an estimated date by which a filing is expected. We have no comment at this time as to whether there has been a breach of this agreement by Endo.

To our knowledge GNI is continuing its work with respect to filing an IND. We have no further information we can provide at this time.

There is an additional $24 million in milestones that can still be earned under our deal with Myriad. We have no information beyond what has been publicly stated by Myriad as to timing of Phase II trial results.

We are still awaiting receipt of local IRB approvals for the crinobulin trial. Sometimes these come quickly and at other times they may take a long time.

Bob Cook