Financial Markets Research: Renovis, Inc.'s NXY-059

Summary

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.

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.

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

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

Contents

• Safety profile and unmet need could drive approval of Revovis, Inc.'s NXY-059
• 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
  • Datamonitor Healthcare
  • Disclosure information
  • Ask the analyst
• List of Tables
  • Table 1: Estimated worldwide NXY-059 revenues 2008-2012
  • Table 2: Estimated worldwide stroke model 2008-2012