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Biotech / Medical : GelTex Pharmaceuticals (GELX)
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To: H. Bradley Toland, Jr. who wrote (69)9/1/1998 9:03:00 PM
From: Robert L. Ray  Read Replies (1) of 127
 
Nice to see someone else still around. I just ran accross this link where the CEO predicts profitability in 2000.

home.snap.com I did a little websurfing on Gelx's obsity drug that is in the very early stages and it looks like they will have competition on it from Roche. Actually I think this is a good thing because Roche has had a devil of a time getting approval for their drug (Orlistat/Xenical) which is a pancreatic lipase inhibitor. Roche filed the NDA in fall 96 and finally recieved a letter of approvability from the FDA in July 98 so I would imagine it will soon get approval. So perhaps Xenical will pave the way for faster approval of GELX's drug someday as I'd hate for it to languish at the FDA for 2 years awaiting approval. Especially since it's so far away from even being submitted.

I only know of the GELX drug from what I read in the 10-K. They hope to identify the lead compound in early 99. They are working on a two fold approach. One is a pancreatic lipase inhibitor so I *assume* it's relatively similiar to Roche's Xenical. In rats they've achieved a two fold increase in fat excretion with this. More intrestingly the 10-K mentions "fat binding compounds" that have achieved a 10 fold increase in fat excretion in rats.

When doing a websearch on Orlistat or Xenical I get back a huge number of hits and most definately get the impression that this is a much anticipated drug among dieters. Some are even bringing it into the country from other nations where it's already approved. One thing is that Xenical is only minimumly to moderately effective. That's one of the reasons it's had a rough road with the FDA. It blocks absorbtion of fat by 30% and the one year weight reduction is 10.2% vs. 6.1% placebo. Two year results are 8% vs. 4.6% placebo. (This is on a diet where calorie intake is reduced somewhat) Even so I'll bet it winds up being a sucessful drug. In this situation I'm reminded of another biotech company called ICOS. PFE's viagra is hugely sucessful and ICOS who is working on a similiar and perhaps better drug has been the beneficiary of a lot of good press and a higher stock price because of the success of viagra. Too bad GELX's drug is in such an early stage or it would get some positive press when Xenical finally gets approval and gains popularity among the nations dieters.

At any rate it's something to think about for the very long term. Let Roche pave the way and then come out with a more effective drug.
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