( This is apparently from a Prudential report , courtesy of gladpick on YMB. Sorry if it's old news.)
pru part 1 -target $45-overweight (Not rated) 29-Jan-07 11:23 am 1/10/07: VRTX: TELAPREVIR EFFICACY DATA IS LIKELY TO BE PRESENTED AT EASL
• We met the management team in San Francisco and gained some insight to the clinical progress of telaprevir (VX-950, TVR).
• Management suggested that the next set of TVR data is most likely to be presented at a medical meeting, possibly the European Association for the Study of the Liver (EASL) in Barcelona, Spain from April 11 to 15. Previously it was assumed that the three-month SVR data from about 20 patients would be communicated to the Street in a press release form.( Have they postponed the release because they want to create a bigger buzz at the EASL venue , or are they praying for better data from the ongoing trials because the currently available data doesn't look so hot ?)
• In addition to previously announced clinical trials of TVR, the company also announced that it will initiate a clinical trial in genotype 2 and 3 HCV patients, an exploratory trial in which TVR is used twice a day without rotonavir boosting and trials in special patient populations, such as HIV/HCV co-infected patients.
• Management felt very confident about its goal of achieve a SVR of 75% or better in the ongoing Phase II trial, initiating a Phase III in ’07 and filing an NDA in ’08.
• Based on a listing on ClinicalTrials.gov, Schering-Plough is planning a new Phase II trial of its protease inhibitor, SCH 503034 (SCH), in previously untreated HCV patients with genotype 1 (Study P03523). The initiation of this trial signals a shift of strategy on SCH 503034 by Schering-Plough. Previously, the company has been focused on developing the drug for HCV patients that have failed interferon-based treatments.
• Because SCH 503034 is a close competitor to Vertex's telaprevir, we thought it might be useful to compare the designs of Phase II trials of these two drugs.
• The biggest difference between P03523 and two telaprevir trials (PROVE1 and 2) is the treatment duration involving the experimental drugs: for SCH it is 24 weeks as the shortest and 48 weeks as the longest; and for telaprevir it is all 12 weeks.
• We think there are plus and minus of both trial designs. Ultimately, the success of a regimen will depend on efficacy (SVR), safety, treatment duration and convenience in that order. Assuming both drugs will succeed in its respective Phase II and III trials based on current designs and be launched, telaprevir has the advantage of treatment duration over SCH 503034. A shorter treatment duration could also mean better safety and patient compliance.
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