I missed last year's annual stockholders meeting of NTII, but I was back in attendance last week. Set forth below are my meeting notes from the 2008 Stockholders Meeting of NTII held on November 13, 2008:
Barry Cohen, Chair, presided over the meeting. About 35 people, mostly officers, directors, and staff, attended.
The only formal business was the election of three directors and the appointment of an auditor.
Paul opened the informal part of the meeting saying that he hoped to give us a ray of light to brighten a gloomy and dreary economic environment.
He showed us the same PowerPoint presentation that he has been presenting at several recent investor workshops.
About Xerecept, he told us that there should be an important announcement this quarter, probably in two weeks, when Celtic Pharma will be presenting at a Neuro-oncology conference. The pivotal clinical trial appears to have been completed, so the fact that Celtic Pharma is making a presentation at such conference bodes well. NTII will be entitled to a 32 percent royalty for US sales of Xerecept, a 20 percent royalty on foreign sales, and 20 percent of the proceeds of a sale of the entire product.
About the Merz royalty for Memantine (Namenda), Paul explained that an agreement had been reached to give NTII a stepped down royalty stream, through 2010. That’s the timeframe within which NTII most needs the money. Paul expects to receive another $10M over that time frame.
About Viprinex, Paul expects to have interim analysis results for the pivotal Viprinex trial this January, with the final results sometime in mid 2009. By then, 650 patients should have participated in the trial. As of today’s date, a total of 600 have been enrolled, and Paul expects the remaining 50 will have been enrolled by the time the January interim analysis is released. As I recall, the final evaluation of each patient is done 100 days after enrollment.
There are 5M strokes per year worldwide.
Paul said that the recent news about TPA’s having demonstrated efficacy when administered up to 4 hours after stroke onset may be a good thing for NTII, because it may help overcome skepticism about a reperfusion therapy claiming to have a 6-hour treatment window, as Viprinex claims to have. Viprinex is expected to have a safety profile superior to TPA, giving Viprinex an additional competitive advantage.
NTII has plenty of Viprinex product in stock. If the product were approved tomorrow, there would be enough supply to go commercial.
TPA causes as high as 40% reformation of new blood clots. Viprinex’s mechanisms of action are superior in that regard, as Viprinex does not cause the re-clotting that TPA does.
Paul had praise for Warren Wasiewski, Vice President, Clinical Programs, with primary responsibility for running the clinical trial program for Viprinex. Paul recruited Warren about two years ago from AstraZeneca, where Warren had responsibility for running the global SAINT trials for AstraZeneca's neuroprotectant drug candidate. That trial was the largest stroke trial ever. It was an unsuccessful trial, but in the process of conducting it Warren had the opportunity to meet key figures in all of the leading stroke centers. At NTII, Warren has been able to use that knowledge to help NTII weed out the hospitals that had been difficult to work with in the SAINT trials.
There are 145 trial sites in 14 countries in the Viprinex trial. The five DSMB meetings that have been conducted thus far have all allowed the trial to continue with no changes to protocol. One can hope that this suggests that elevated brain bleeds are not a big problem, but at this point we have no assurance that efficacy is being achieved. The January 2009 interim analysis will be a futility analysis of 500 treated patients. Final analysis of all 650 patients is expected by mid 2009.
NTII has no debt. It is currently trading below cash. As of September 30, 2008, the cash price would be $1.25/share. As of June 30, 2008, there was $48 million in cash.
Only one person asked questions during the Q&A, and this time it wasn’t me.
There are a few, but only a few, patients being treated with Viprinex during the first 3-hour window. Patients arriving at the ER during that 3-hr window get TPA instead. Except in Poland, where for political reasons TPA is not available to the average patient. At the trial center(s) in Poland, some patients are getting treated with Viprinex within the 3-hr window.
The FDA has told NTII that if Viprinex works in patients being treated in the 3+ to 6 hour window, the FDA will also approve Viprinex for treatment during the 3-hour window.
The trial protocol’s exclusion criteria exclude patients that have had prior strokes.
Most of the facilities participating in the trial only enroll one patient every three months.
The questioner asked about some very positive anecdotal reports from a Houston facility. Warren said that anecdotal reports are meaningless at this stage. The randomization is not per site but across all sites. Clinicians at some sites try to guess which patients are receiving drug and which are getting placebo, thinking that half of their trial patients are in each group, but that may be a false assumption. There is no way for them to know. It is possible that all or nearly all of their patients were given placebo. So you cannot trust anecdotal evidence from various trial sites. All the more so, because 20 to 25 percent of stroke patients will improve on placebo or no treatment at all.
The January futility analysis will just be a go no-go analysis.
Warren admitted that there is plenty of uncertainty about how Viprinex will fare in this pivotal trial. When Warren joined the company two years ago, Paul asked him what chance Viprinex would have for success. He told Paul then that it had only a 30 percent chance of being successful.
After the meeting I cornered Warren and asked him to explain how he came to that thirty percent figure. He said he based it upon the following facts:
(1) the difficulty of succeeding in a stroke trial.
(2) the fact that the drug failed in one of the three past Phase II and Phase III trials.
(3) the fact that the current dosing regimen has not been previously tested in humans.
He mentioned how important it is to not grant any protocol waivers to the trial doctors, because the FDA will throw out the data. When he joined NTII two years ago, there had been a couple of instances of Warren’s predecessor having granted doctors waivers. Warren abruptly brought that practice to a halt. He also revised the protocol’s inclusion and exclusion criteria at that time. About 200 patients had already been treated under the prior inclusion and exclusion protocol. But the FDA approved the change in protocol and agreed to accept trial results from the first 200 patients that had already been treated under the prior protocol.
He said that the mean and median average time that patients in the trial are receiving treatment is about 5-1/4 hrs after the onset of the stroke. That seemed to me like a difficult cohort in which to show efficacy, but Warren was optimistic because some of the prior trials (the successful ones) of Viprinex had shown efficacy in that cohort.
Warren said that he personally is riding herd on the trial sites to make sure that they are not allowing any waivers to the approved protocol.
Warren impressed me during my private one-on-one exchange with him. He seems like an excellent communicator and so I believed him when he told me that the doctors at the trial sites "get it" when he explains that the results will be ignored by the FDA if there are exceptions/waivers to the approved protocol.
Marc |
