NuPathe’s Zelrix is a transdermal sumatriptan patch for the treatment of acute migraine headaches currently under review by FDA. It has the potential to be the first triptan patch to reach the US market. NuPathe plans to position Zelrix as a second line treatment for patients who are dissatisfied with their current triptan treatment, such as those with nausea and vomiting. This represents a fairly large market opportunity. In this report, we review Zelrix's clinical data, its performance relative to other sumatriptan and triptan formulations, the market opportunity for non-oral triptans as well as the key regulatory risk ahead of the August 29th FDA decision date.

Published: July 13th, 2011

Number of pages: 25

Authors: Dr. Susan Molchan and Dr. Ilana Fogelman


TABLE OF CONTENTS
-------------------------------

INTRODUCTION
-----------------------
1. Migraine
- Sumatriptan is a well-established migraine therapy
- Limitations to use of oral medications
- Prevalence
- Current treatments
- Safety and tolerability of sumatriptan
- Not all triptans are equal
- Other treatment options

THE ZELRIX PATCH: A NEW SUMATRIPTAN DELIVERY TECHNOLOGY
----------------------------------------------------------------------------------------------------
1. Pre-clinical development
2. Clinical data
- Phase I/Pharmacology Studies
- Pivotal Phase III Clinical Trial
- Open-label 12-month extension of phase III trial (NP101-008)
- Safety study NP101-009

CLINICAL AND REGULATORY DISCUSSION
--------------------------------------------------------------
1. Options for patients who do not tolerate oral triptans
2. Efficacy and safety relative to other triptans
3. Are the data adequate to support approval?
4. Rebound or recurrent headaches
5. Labeling considerations
6. FDA review of combination products
7. Patches are not a new technology, but regulatory standards are evolving
- An evolving regulatory paradigm
- The main regulatory risk

MARKET ISSUES
-------------------------
1. Overview
2. Current competition
3. Zelrix revenue projections
4. Pipeline of migraine products in development

SUMMARY OPINION
----------------------------