ORPH
The interest in ORPH here is contagious. I'm sorry if my newfound enthusiasm is oblivious to prior discussions on this forum.
I've been doing some digging to try to answer some of my questions about this company whose main revenue producing drug (Xyrem) has the oddest, regulated prescribing system I have ever come across. I initially thought the system is so cumbersome that it would exert a heavy drag on the ability to expand sales. But, after some research, I think it is a pretty inexpensive and not too cumbersome way to distribute a drug that the FDA would otherwise not approve. I would like to talk to a doc who has prescribed the drug (anyone here?), but IR is pretty reassuring that after the initial prescription and getting on the registry, the process is not onerous for patient or provider for repeat prescriptions.
My main question is how comfortably docs will prescribe this drug for off-label indications--which is clearly where the profits lie. With Provigil, off-label use has been rampant and there seems to be little scrutiny. But, with Xyrem, the cataplexy indication itself is certainly not going to provide significant revenue. There is a long history of street use and anecdotal clinical experience that GHB improves sleep quality and may enhance alertness, among other things. But, with the close scrutiny that prescribing docs must feel in using this drug, I wonder how comfortable they will feel using it in people that have various symptoms, but who do not meet the criteria for diagnosis of cataplexy or narcolepsy.
I also would like to know if the prescribing and regulation environment in Europe is likely to be any more conducive to off-label use than in US. Orphan is clearly expecting a regulatory decision in Europe regarding the cataplexy indication early in '05. Does anyone know if the distribution and prescribing system would be less restrictive there?
Finally, can anyone point me to data on Xyrem use in fibromyalgia? That,of course, is the potential homerun for ORPH.
Thanks,
Urche
Market Data 
Markets 
AI
