NIBM - December 2002 newsletter

December 2002 (v02-n12)

Main Story - pgs. 1-12 Onyx Pharmaceuticals
Macro Market Commentary - pgs. 13-14
NIBM Model Portfolio Updates - pg. 15-21
NIBM Model Portfolio - pg. 22
(Full outline below...)

This month's Main Story explores recent newsmaker Onyx Pharmaceuticals (NASDAQ:ONXX). Onyx's original claim to fame was as a gene therapy company, even though most scientists don't believe their lead product (ONYX-015) is truly gene therapy. Now that gene therapy is out of favor on Wall Street, neither does the company.

Onyx was recently in the news for BAY-43-9006, a raf kinase inhibitor creating some excitement in the scientific and investment community. We examine this drug, ONYX-015, and the company's plans for both in 2003 and beyond.

The following is an outline of this issue of the NIBM Newsletter.

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Main Story - Onyx Pharmaceuticals

Introduction

Table: Basic Facts

Disclosures

Investment thesis

BAY-43-9006

Table: BAY-43-9006 co-development arrangements

Signal Transduction Inhibition

Gleevec: the STI poster child

The target

Table: BAY-43-9006 clinical trials

Clinical results for BAY-43-9006

ONYX-015

Gene therapy basics

The vector

The adenovirus vector

ONYX-015 specifics

The "target"

The problem

Clinical experience

Direct injections versus systemic delivery

Single agent versus combination therapy

Table: Selected ONYX-015 trials and results

Suspended Trial

Manufacturing

Patient accrual

Method of action

The rest of the Onyx story

Table: Onyx Milestones

What Can Go Wrong

Macro Market Commentary

NIBM Model Portfolio and Updates

Discovery Labs

Surfactants

Surfactant proteins

Table: Characteristics of lung surfactant proteins

Lung diseases

Respiratory Distress Syndrome (RDS)

Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury (ALI)

Meconium Aspiration Syndrome (MAS)

Respiratory Syntactical Virus (RSV)

Table: Description of late-clinical phase indications for Surfaxin

Alteon

ZymoGenetics

Genta

Indevus