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Biotech / Medical : Corcept Therapeutics Incorporated (CORT)

CORT 73.50

+1.7%

Oct 31 3:59 PM EST

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From: Clarksterh	12/11/2004 1:16:10 PM
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My notes from the Harris Nesbit Investors Conference of 12-8-04. Much of this is a rehash of data seen elsewhere, but being new still of interest to me. Not being a stenographer I am sure I captured some items incorrectly, but hopefully the errors are small. Apologies for the terse notes, but too lazy to expand them into proper english. Inre support that Corlux has a response durable to 56 days. Corcept was made clear that when the ’03 was about ½ finished the FDA decided they wanted a changed endpoint. A move from 28 days to 56 days. So they started tracking everyone who had not yet finished and still showed stat sig for those people who were more than 50% improved on both day 7 AND 56. This is important because it removes the concern that the 56 day durability was assessed only in a self selected subgroup. Will have results from the two previous trials published in peer reviewed journals within the next year. Will have the IND for the next generation drug into FDA sometime in 2005. Expect that the next generation will not interfere with progesterone. Price per mg is currently $400 for 600 mg for abortion in cheapest case (Planned Parenthood). So a minimum cost is 7 times that, but clearly pharmicoeconomics would allow a much higher price. There is a retreatment arm of the studies which allows relapsed patients on these studies to be redosed for a year. Combined cost of ECT and hospitalization, based on Stanford study, was $70k. Even though it is being used for acute care, FDA required a 2 year tox/onc rat study. Should not be schedule limiting for commercialization. Side effect profile. Few side effects. Noted a statistically significant increase in rash, but easily dealt with in the trial. Primary benefit of the second generation would be to allow chronic use. Don’t want to be selling a progesterone blocker for chronic use. Clark

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