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Biotech / Medical : AMLN (DIABETES DRUGS)
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To: D.Right who wrote (1263)3/10/1998 11:12:00 AM
From: Rudy Saucillo  Read Replies (2) of 2173
 
Agreed. Most of my comments were "old news". I was simply comparing AMLN vs. ERGO and showing that ERGO represents a substantially lower risk and much greater financial potential than AMLN at this point in time - for JNJ and investors.

The AMLN data released last Aug. is very weak considering that AMLN had to search for a subgroup of trial participants that reached the -0.5% change in HbA1c point. This was not an apriori decision. They had to dig for positive results. It's not clear to me that the FDA (or Europe) will give even limited approval based on this minimal response in a patient subpopulation. An effective glucose control drug should, ideally, drive insulin requirements down; not be overwhelmed by it.

Assuming that eventually the FDA does approve pramlintide for use in Type I patients with poor glucose control with stable insulin dosing, it's important to realize that this is a small percent of Type I diabetics. Hence my previous comments that this is no $300-$400 million drug. One more comment...the FDA will not give blanket approval for use in all Type I's if the Phase III data doesn't support it and it's unlikely physicians will use pramlintide off-label if overall efficacy hasn't been established.

I hope the ongoing trials are substantially more positive than the previous ones. But, IMO, there's no reason to believe they will be.

BTW, I have no vested interest in the performance of AMLN stock. I've never been long or short AMLN and have no plans to.
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