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Biotech / Medical : MEDX ... anybody following?

MEDX 31.58

+1.4%

Nov 5 12:44 PM EST

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From: Icebrg	6/6/2007 1:03:36 PM
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Posting on Yahoo attributed to Morgan Stanley (non-verified). Conclusion: Updated data at ASCO increase our confidence in the approvability of ipilimumab as 1) most physicians believe a near 10% response rate achieved by ipilimumab could be sufficient for approval, especially given the long durability of these responses, which are unprecedented in melanoma, 2) response rates do not fully capture efficacy as stable disease can be very durable as well, implying potentially extended survival even when its not a clear response, 3) responses could improve over time (i.e. SD to PR or PR to CR), potentially making the data set better, and 4) toxicities are very manageable. What's New: Medarex presented updated Phase I and II data at ASCO (monotherapy and combination data for ipilimumab in second line melanoma). Key data included: 1) At the 10mg dose, the ORR is 9% and SD is 30%; both sets have durable response with some exceeding a year. 2) The overall response rate across four trials with a range of monotherapy doses (0.3 to 20mgs) is ~10%. 3) Duration of responses are compelling; nearly 25 patients (from 356 patients, which includes all six trials) have responded greater than 5 years; typical life expectancy in this setting is 7 to 10 months. 4) Responses could take time; in nearly 60% of responders, response were observed after 12 weeks. Implications: We continue to view Medarex as an attractive investment opportunity. We believe that ipilimumab will likely meet the criteria defined in the SPA for second line melanoma (which is on totality of data and not only response rates). Success of ipilimumab in this indication could easily take the stock into the $20+ range. Additionally the durability of responses also support extended survival, which increases our confidence in the ongoing front line trials (where the endpoint is PFS), and could provide additional upside. Upcoming catalysts include: Second line melanoma data in the Oct./Nov. timeframe and front line data in 2008 messages.finance.yahoo.com

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