Phase 3 and the Patience of Job If voclosporin clears the Phase 3 trial hurdles in the US and Europe - two trials will be done with 600 patients enrolled in each - the drug will likely be launched in 2015 or 2016. The stock value would rise of course before then, but in my view not significantly before the end of the Phase III trials, unless voclosporin is approved for indications other than transplantation before then, and that's not an impossibility. Currently we are waiting for news on the initiation of those trials.
I believe we have reason to be cautiously optimistic about the outcome of the Phase III trials. As an article posted in "BioTuesdays" on Oct. 25th, 2011 - quoting Robert Foster - stated, "in a large Phase 2B study, involving 334 patients, voclosporin was as effective as tacrolimus in preventing rejection of a transplanted kidney. More importantly, volcosporin was superior to tacrolimus in several important safety areas, including the incidence of new onset of diabetes (that's the NODAT I've referred to in earlier posts). Specifically, patients receiving voclosporin in the blood concentration ranges planned to be used in Phase 3, had, on average, a 65% reduced risk of developing diabetes, compared with tacrolimus, the current market leader." Personally I expect voclosporin might even be better than that (i.e. from 3 to 10 times safer, but that's just my personal opinion in reading between the lines of the Promise study results), but this is the best statement based on a conservative reading of the trial results.
We need to also be reminded that NODAT is not the only area where voclosporin has an edge over tacrolimus. These other areas represent the icing on the cake - and also are the areas where the superiority of voclosporin for other indications will make it the drug of choice as we move forward. Those areas - also extracted from the same article are gleaned from these observations: "Patients on voclosporin in the Phase 2b study also demonstrated preservation of magnesium levels, whereas patients taking tacrolimus exhibited altered magnesium homeostasis leading to hypomagnesemia. These lower levels of magnesium with tacrolimus use can lead to cardiac arrhythmia, hypertension, muscle cramps and increased irritability of the nervous system, resulting in tremors, confusion, hallucinations and insomnia. In addition, voclosporin showed a reduced incidence of elevated triglycerides, which are a contributing factor to cardiovascular risk."
These are the reasons we need to remain focussed on the future. Where ISA goes in the future has nothing to do with personality or personal disappointment, or the perception of bad management. New drugs take an agonizingly long time to pass through the approval processes. I'm a small investor here and put my meagre money on this drug a long time ago - because of the science. I did the same thing - for essentially the same reasons many years ago on what then was a small Canadian aerospace company called SPAR. They did well, and I made a little bit of money then. I expect to do that again here with ISA. My patience has been tested almost to the limit, but, I'm holding on, because I understand that the science is good, that the market is huge, and that there are no rivals standing in the wings to outflank voclosporin.