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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (2417)12/29/2000 11:22:42 AM
From: rkrw  Respond to of 52153
 
I have UC so I have a little bit of experience here.

<<The dose that people have to take is huge - 6.75 grams/day. Wonder if that might limit its utility?>>

I took a quick look at the co website. This drug is actually a pro-drug of sulfasalazine. The Salix drug is sulfasalazine without the "sulfa."

Standard prescription doses of sulfasalazine is 3 grams per day, or 6, 500mg pills. I take closer to 2 grams/day when I'm doing well. I'm not sure why the required dose is more than double its predecessor.

One critical issue is that it looks like the FDA gave them a poor label, in that it's approved for _up to 12 weeks_ of use rather than approval as a maintenance medication, as sulfasalazine is used for. For reference I've been taking sulfasalzine for 6 years now.

The drug was actually given an "approvable" letter in the Summer of 1997, so it sat for three years while they worked out the label.

This drug will obviously be marketed as a successor to sulfasalazine. One would need to find out why it was given a short label and whether in practice it will be used as a maintenance med off label. It's also going up against a generic market, which can be tough. Sulfasalazine is effective in maintaining remission. The worst side effect I've encountered is a persistent moderate dry mouth.

I'll certainly inquire about this new drug.