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Biotech / Medical : CEPH - CEPHALON
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From: DewDiligence_on_SI3/23/2006 11:19:17 PM
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Sparlon musings:

tinyurl.com

I’m not fully convinced that CEPH will bother with additional Sparlon studies requested by today’s advisory panel if the FDA insists on them. The main reason CEPH developed Sparlon in the first place was to make an end run around the loss of patent protection on Provigil, which is the same drug. However, now that CEPH has settled the Provigil patent case with all four challengers, one wonders how important Sparlon really is to CEPH.

Provigil has already garnered substantial off-label sales in ADHD. Moreover, the supposedly optimal Sparlon doses of 340mg and 425mg are easy to approximate with 1.5 and 2 Provigil 200mg tablets, respectively. (I always assumed that the unusual doses for Sparlon were a ruse to distinguish the product from Provigil in case CEPH lost patent exclusivity on Provigil.) Further, a high-ranking FDA official (Robert Temple) has already stated on record that, if Sparlon is eventually approved, it will have a black-box warning for Stevens-Johnson Syndrome (SJS).

CEPH may be almost as well off with the existing off-label Provigil sales in ADHD as they would be with an approved ADHD indication that carries a black-box warning. Moreover, there’s a non-trivial risk that additional safety studies would turn up more cases of SJS and end up destroying the off-label sales of Provigil. JMHO, FWIW
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