I attended all three of Paul Freiman's presentations at the Bio InvestorForum today. He participated in the Stroke discussion panel, gave his own company presentation, and then did a break-out session.
Near-term events that could move the stock:
In November he'll be presenting (I forget at which conference) the results of the open label trial of Xerecept. You'll recall that Phase III patients who want to stay on the drug after the trial protocol ends are being allowed to do so, and their progress is monitored as an open label trial. Paul intimated that the results of that trial are very good.
In January they expect to release the results of the Xerecept Phase III trial(s). Paul's "tea leaf reading" is that they will meet their endpoints.
They're shooting to provide an Interim Analysis of the two Phase III Viprinex trials next summer.
Paul is hoping to partner Viprinex with a major Pharma company for the Asia and European markets. He has enough cash for another year but knows he needs to raise more cash before much longer.
The Viprinex trials have been enrolling slower than expected. Paul is hoping for a "hockey stick" pattern -- a rapid turn upward after a long and slow build-up. He gave three main reasons for the slow enrollment: (1) the legacy of the failed Knoll Phase III trial -- the memory of that failed trial is a definite taint, (2) poor communication by NTII to the clinicians about the unique mechanism of action of Viprinex, and (3) competition from other stroke therapeutics in the clinic.
About #3, he mentioned that there is now less competition since Renovis's therapeutic has completed its enrollment.
To fix #2, Paul hired a NY firm named Health Science Communication, a Division of OmniCom (sp?). Although their main task was to help Paul communicate to clinicians, he was using at our investor conference, for the first time, the new slide-show presentation developed by HSC. It was very kooelll.
I'll digress. The slide show graphically displays a fibrinogen molecule and shows how it has an alpha chain and a beta chain attached to it. Those two chains prevent the fibrinogen molecule from binding to other fibrinogen molecules to form blood clots. Thrombin acts to cleave the alpha and beta chains from the fibrinogen molecule, converting it into blood-clotting fibrin. Viprinex competes with Thrombin. But whereas Thrombin cleaves both the alpha chain and the beta chain, Viprinex only cleaves the alpha chain and leaves the beta chain intact. As long as the fibrinogen still has its beta chain attached, it will not bind to other fibrin molecules in a uncoordiated clotty kind of way, but will only bind to them in parallel chains, which don't form clots and pass easily through the bloodstream without causing problems. The graphics were great at showing all this.
Paul is very pleased at the clinical community's response to the new slide show. He said that whereas NTII only managed to place a very small booth at the Stroke medical conferences last year, they are being given a major-sized booth at an upcoming Stroke conference.
Paul was very pleased about just having enrolled 17 new sites in Russia. Sites in the Czech Republic and Poland are also enrolling. On the Stroke discussion panel, someone mentioned (maybe it was Paul) that Russia does a better job than any other country at getting Stroke victims to Stroke-specialized hospitals in the shortest time. Although the Stroke specialists rotate from hospital to hospital in Russia, all the ambulance attendants and other emergency responders are given the sepcialists' schedules each week, so they know where to take victims presenting with the symptoms of a Stroke. The first responders must also be well trained in recognizing the symptoms of a Stroke.
In the breakout session, Paul mentioned quite candidly that there is a chance that NTII would lose its 1% royalty on sales of Namenda for AD. The way the contract with Merz is written, if Namenda proves to be ineffective at treating Neuropathic Pain, then Merz can cancel the contract. If, on the other hand, Merz elects not to pursue Namenda for NP for economic reasons, then NTII's royalty increases from 1% to 1.6%. Paul isn't worried. Although the market would be upset about him losing the 1% royalty, he thinks it might be worth it to get back the rights to develop Namenda for NP and AIDS-related dementia. But the bigger reason he's not worried is because (a) he regards the Merz people as friends and doesn't expect them give him the shaft and (b) the contract's arbitration clause would only allow Merz to conclude that Namenda is ineffective in treating NP if Merz had used its "best efforts" to develop the drug for that indication, and in NY, the venue for any arbitration of the contract, the "best efforts" standard is a very tough standard.
Paul called "ballsy" NTII's decision to go forward, into Phase III trials of Viprinex, with a protocol that had never been tested in a Phase II trial. The protocol being used in the Phase III trial involves a high dose of Viprinex for just 24 hours and then no more, whereas earlier trials had used a lower dose over a longer period of time. He took pride in having been able to persuade the FDA to allow NTII to proceed with a Phase III trial using this protocol, and boasted that they'd made a very convincing presentation in support of the protocol.
I ran into Bulbaman at the MNTA presentation, but then I had to bet back to work.
Cheers,
Marc |
