FYI. I clipped this from the Yahoo IPIC thread. It's by Neuroinv.
1) In the aftermath of CerAxon's disappointment in the MRI trial, I continue to believe that this says virtually nothing about the drug. The other three Phase IIIs were in the 260-270 pt range, 87 patients was not enough. Had there not been a fluky placebo effect, we might have seen trends supportive of efficacy, and we would all be toasting management now. Hindsight suggests other trial strategies that would have avoided this pitfall, at considerable financial cost and time-requirements. That is moot; small companies do not have the infinite resources to carry out three 1700 pt studies as Janssen is doing with ProSynap...IPIC tried to chart too fine a course. The next study will probably end up with 900-1000 patients to reduce as much as possible any chance of population skews.
2) Re: Bextra....there was a very good post a few days ago noting the NIH wish to incorporate a variety of patient subgroups in significant numbers...I still anticipate significant, positive results from the Phase III, but the length of time it has taken does raise the question of whether superiority in efficacy can be expected. Instead, Bextra may depend upon a better side effect profile. SmithKline sold $44million of Coreg during the first 6 months of its launch and predicts a considerable improvement in sales rate. Coreg's introduction does open up physician interest in this class of beta-blockers, so I would expect Bextra to do as well or better even though it will be the second in its class to receive approval. I do not know anything more than anyone else on this thread re: when the trial will end...sometime over the next few months. My belief is that there is a very effective firewall between the safety committee and everyone else, so rumors are just that.
3) Pagoclone is now the wild card...because anxiolytics are prescribed by such a wide range of practitioners, IPIC always knew it would need Big Pharma comarketers...in the US and Europe (they lack only the rights in France, which RPR retained). Pagoclone is ahead of the anxiolytic competition from Neurogen, CoCensys, NeuroSearch, to name but three, and strong Ph2/3 results in panic disorders would spur a lot of Big Pharma interest. Upfront licensing money from such deals would take care of much of 1999's cash flow issues.
4) Speaking of cash: I have yet to receive a Pink Sheet stating that IPIC has but 35 million in cash. That posting was probably a clever hoax, but if not, it is flat out wrong. Not counting monies that are InterCardia's, and accounting for 1Q burn, I estimate IPIC has $65-70million on hand. At the current burn rate, they would run into problems mid-1999, which is where pagoclone licensing fees come into play.
5) PACAP is an inexpensive addition to the CNS portfolio. I have concerns about adding non-CNS in-licensings at this point given the burn rate, but PACAP plays to the company's strength. The use of a (relatively) small molecule to spur endogenous neurotrophin production is not a new idea, NeoTherapeutics has a number of such molecules. PACAP appears to operate in a different way, and there is some disagreement about its effects upon cell proliferation and differentiation. This is not a proven technology; I am still reviewing my information on it, but PACAP has not been a 'hot' area in neuroscience. Just as a crude measure; around 40,000 papers/posters have been presented at the last two Society of Neuroscience meetings altogether. 'Hot' areas can be covered by 100s, even thousands of papers. A total of about 20 or so PACAP papers were presented over two years. This may mean that IPIC has come up with an unrecognized 'jewel in the rough', time will tell. PACAP is not a 'replacement' for CerAxon, this deal was being developed long before the MRI trial failed.
NeuroInvestment (www.neuroinv.com) |
