I was just preparing some comments on citicoline developments, so here they are, partly responding to the enthusiasm of the ER Doc post:
The market for citicoline is potentially huge, though I would hesitate to throw in MI, dementia at this point. Since there is some European data on TBI, some off-label usage is possible. IPIC may well target CABG patients next, trials starting after the NDA is filed. But even without nonapproved indications, ischemic stroke itself is huge.Even though the labelling may call for its use only in patients with NIHSS scores of 8 or more (meaning moderate to severe) that in itself covers 75% of the stroke population (i.e. 300-375,000 US patients annually), even patients with minor stroke symptoms may get it, because it is relatively cheap (500-800 per month is my projection) and very innocuous; few side effects, taken orally. Practicing neurologists I have spoken to who are familiar with citicoline wonder how any of their number would justify NOT prescribing citicoline. One could certainly imagine much CYA prescribing of citicoline, because who would want a stroke patient with lasting impairment filing a malpractice suit because they had not received the only drug available for patients who arrive at the ER more than 2-3 hours after the infarct ? (only 15% arrive in time to have the necessary CT scan before starting t-PA within the 3 hour 'window'). My 1998 projections for citicoline revenue (in a model I built for my last review of IPIC in 9/96) had been around $34 million, 1999 $129 million. I believe that both these figures may well be on the low side. Since IPIC only has to pay 6% royalty to Grupo Ferrer and perhaps a percent or two to MIT, and citicoline is cheap to make, this is a high margin product once they have their sales force and marketing on-line. Even if they take on a big partner to help market to hospitals, IPIC will take the majority of the revenues. The big question relates to timeframe: I totally expect the FDA to approve citicoline; if they require an FDA Advisory Committee meeting, that will simply slow down the inevitable.
Given the consistent positive benefits shown by citicoline, and the lack of any negative, this drug will be approved and ready for launch by mid-year 1998. A best case formulation might accelerate that somewhat, but that cannot be relied upon. What the market failed to appreciate today, and may not for some time, was that the citicoline success in a second Phase III was, in the longterm prospects of the company, the biggest news they have ever had. Even the rosiest early predictions for Redux would not have left IPIC earning more than $80-100 million in a year from royalties, now it is looking like a maximum of $20-30 million at best. Citicoline should beat even the rosy expectations easily, and it is far more important to IPIC than Redux ever was, or ever will be. NeuroInvestment |
