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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: ewolf who wrote (1925)	4/10/1998 1:42:00 AM
From: Peter Singleton	Respond to of 4676

A couple of more points to add to ewolf's summary: _ ISIP received $5M from Ciba as a milestone for the NDA filing. They have received $10M of the contracted $20M in milestones. The other $10M will be split between NDA approval and European regulatory approval _ They expect to file in Europe shortly. _ ISIP expects approval by the end of the calendar year. The CMC reviewer has indicated she expects to be done in 3 months. On the medical side, maybe 4-5 months. _ they've been pleasantly surprised by the safety. Also, they are happy with the dosing results of their CS9 trial in refractory patients. Every 4 weeks in maintenance mode has comparable efficacy to every 2 weeks, with better safety (due to fewer injections). Only concerns with approval are limited number of patients, which were fewer than they had hoped. This is due to much fewer incidences of CMV retinitis. _ they seem to be counting on a rebound in CMV retinitis for there to be any significant revenues from this drug. _ the Ciba deal is structured to get ISIP 50% or more of the profits. _ study CS3, fomiversen + oral gancyclovir vs. oral gancyclovir alone has not reached the interim evaluation point. There's not enough visibility on efficacy to indicate whether there is a benefit in dosing the two together, however, there appears to be no incremental safety issues in the combination, and they'll request that to be part of the labeling. _ 13312, the next generation CMV drug, is planned to progress through PI, ready to enter (the more expensive) PII trials if the CMV market rebounds. hoped for benefits from the pre-clinical work are less frequent dosing (every 3 months?), and less inflammation. _ fomiversen side effects are be anterior chamber inflammation and intraocular pressure, both limited in frequency and severity, and appear mostly in the induction period only. % of retinal detachment is very low. as per the ISIP website, the con call recording can be replayed until about 10:30am EST Friday April 10 by calling 1-800-633-8284, reservation 4129752#. I didn't time the call, but my guess is it's about 30 minutes. Peter