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Overview

Introduction
Renovis and AstraZeneca’s NXY-059 is viewed as the most promising neuroprotectant currently in development for stroke, however, much of its potential is dependent upon its ability to demonstrate a benefit in the recently enrolled SAINT-II trial.

Scope
Analyzes the regulatory and commercial potential for RNVS’ NXY-059, a novel agent that aims to reduce brain damage post-ischemic stroke
Datamonitor interviewed four neurologists familiar with NXY-059 and its clinical data regarding its potential for the treatment of ischemic stroke

Highlights
Pending results from the Phase III SAINT-II trial expected later this year, we estimate that NXY-059’s safety profile and the modifications to the Phase III trial could support its eventual approval in early 2008, leading to blockbuster potential by 2012.

If approved in early 2008, we expect that Renovis and AstraZeneca’s NXY-059 would be rapidly utilized in eligible patients due to its strong safety profile and lack of alternative options.

As a result, we forecast worldwide NXY-059 revenues that fall only slightly below long-term Wall Street consensus.

Reasons to Purchase
Understand the regulatory and commercial potential for Renovis’ NXY-059 through in-depth analysis, based on interviews with leading experts
Anticipate likely changes in the future market dynamics for stroke therapies if approval of NXY-059 occurs

Table of Contents

SUMMARY
Safety profile and unmet need could drive approval of Revovis, Inc.‘s NXY-059
RENOVIS
Overview
NXY-059 (Cerovive)
ISCHEMIC STROKE
Overview
Use of DNA’s tPA, the gold standard, severely limited by time to ER presentation
SAINT-I trial suggests potential for novel neuroprotectant in treatment of stroke
SAINT-II aims to clarify benefit of NXY-059, results expected in late 2006
FACTORS AFFECTING THE POTENTIAL FOR NXY-059
Historically, neuroprotectant trials have been widely unsuccessful
STAIR group approval should improve chances of approval
Eventual NXY-059 pricing still unclear
Pre-treatment mortality and time to presentation to limit NXY-059 potential
SAINT-II design modifications could improve regulatory chances
DATAMONITOR NXY-059 FORECAST
Longer therapeutic window should drive NXY-059 utilization and uptake
Potential upside may exist in ambulatory and broader NXY-059 administration
APPENDIX
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List of Tables
Table 1: Estimated worldwide NXY-059 revenues 2008-2012
Table 2: Estimated worldwide stroke model 2008-2012