Main Story - pgs. 1-47 Dendreon

Macro Market Commentary - pgs. 48-50

Biotech Monthly Coverage Update - pg. 51-63

NIBM Model Portfolio - pg. 64

(Full outline below...)

Dendreon (DNDN) is a development-stage biotechnology company whose core platform targets the immune system against cancer. It is the only immunotherapy company to see success in a Phase III clinical trial against cancer. We first began our coverage of Dendreon in 2001. This issue represents a comprehensive, updated look at the company, incorporating over four years of coverage updates into one place.

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Main Story - Dendreon (DNDN)

Introduction

Table: Basic facts on Dendreon

Disclosures

Investment Case

Basic Science of Immunotherapy

The human immune system

B-cells

T-cells

Antigen presenting cells

CD4+ and CD8+ T-cells

Where things go wrong

 

Cancer biology

Disease Darwinism

Disease evasion

Evasion by chemical warfare

Evasion by camouflage

Evasion by resistance

 

It is all about the antigen

Autoimmune danger

Bad antigen choice

Dendreon's immunotherapy platform

Single vs. Multiple antigens

Antigen engineering

Expert fiddlers

Manufacturing

The process

Table: Provenge manufacturing process

Longer is not better

Success rate

Product characterization

Antigen cassette manufacturing

 

Provenge

Prostate cancer

Grading the disease

Graphic: Gleason score histogram

Treatment stages

Table: New stages of Prostate Cancer treatment

The target

 

Provenge clinical trials

Early clinical data

Initial Phase III program

D9901

Sub-group analysis

Onset of pain

ASCO 2003

Side effects

Survival advantage

No enrollment imbalance

Table: D9901 Patient demographics

Table: HRPC Nomogram survival predictions

Subsequent therapy

D9902a

D9902b

Endpoints

Criteria departures

Enrollment progress

PROTECT (P-11)

FDA endpoint discussions

D9905

P-16

Provenge clinical trials

Initial label

Later stage disease

Early stage disease

Repeat dosing

Timing

Off-label revenues

 

Provenge competitors

Taxotere

GVAX

Atrasentan

 

Provenge approval

FDA leadership

Gleason confusion

Label question, not approval question

Enrollment imbalances

Doctors see it as approvable

Back to the future

A new pooled analysis

Most likely scenario

D9902b label expansion

Summary

Provenge partnership

Ex-US partnership agreement

Table: Projected ex-US Provenge deal

Partner

Deal Terms

Worldwide deal

Table: Projected worldwide Provenge deal

Partner

Summary

Provenge timeline prediction

Completion of D9902b

Filing of the BLA

D9901 filing

D9902b filing

Partnership

Neuvenge (APC-8024)

Target

Phase I program

Trial 2000-2

Trial 2000-1

Phase II trial(s)

Johnson & Johnson partnership

Potential market

trp-m8

Partnership

Progress

Pipeline target antigens

NY-ESO1

CEA

CA9 (Formerly 'MN')

hTERT (telomerase)

Serine protease

Alternative Reading Frame (ARF)

What Can Go Wrong

Table: Biotech Monthly's Timeline Estimates for Dendreon

Macro Market Commentary - "Rosy outlook"

Biotech Monthly Coverage Updates

Medarex

MDX-010 partnership with BMY

Table: Medarex + Bristol MDX-010 partnership

MedImmune deal

Medarex as acquisition candidate

Medarex at ASH

BioMarin

Daiichi Suntory deal

Table: What BioMarin gets, what Daiichi gets

Aryplase BLA

Discovery Labs

Corcept

Subsets

Important exclusions

Alzheimer's disease

Investment Case

Forbes Medi-Tech

Genta

Table: Genasense CLL checklist

Other Genasense at ASH

Investment case

ID Biomedical

Indevus

Introgen

Seattle Genetics

Table: SGEN at ASH

Pharmos

Valentis

Competition

ZymoGenetics

Table: Zymo at ASH

Alteon

Aphton

NIBM Model Portfolio Performance