Main Story - Zonagen (ZONA) - pgs. 1-16

Main Story - Hana Biosciences (HBX) - pgs. 16-21

Macro Market Commentary - pgs. 22-26

BSR Coverage Update - pgs. 13-39

BSR Model Portfolio - pg. 40

(Full outline below...)

This month's Biotech Monthly Main Story is a two-for-one. The first part is on Zonagen (ZONA), a company that plans to sell its two drugs to the highest bidder soon after initial Phase III data arrives. Androxal is a new therapy that restores testosterone production in men. Proellex treats uterine fibroids and endometriosis.

Hana Bio (HBX) will file for an NDA on Zensana, a superior delivery form of the $1.5B anti-nausea drug Zofran. This oncology-focused company will follow with Talotrexin, which they hope is a superior from of Alimta and methotrexate.

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Main Story - Zonagen (ZONA)

Introduction

Table: Company statistics

Disclosures

Investment Case

Androxal

Hypogonadism

Which normal is normal?

Bias against testosterone therapy

The ideal drug

Androxal data to date

Phase I/II trial

Table: Androxal Phase I/II study

Phase I "mixed healthy" trial

Current Phase II/III trial

Difficult regulatory pathway

Trial nuts & bolts

Table: Phase II/III trial endpoints

Additional work needed

European differences

Competition

Generic Clomid

Androgel

Nebido

Testosterone sprays

Market sizes

Table: Market assumptions for next decade

Proellex

Indications and current treatments

Uterine fibroids (myomas)

Endometriosis

Clinical data

Asoprisnil

Mifepristone

Next clinical trials

Phase II/III Uterine fibroids

Endometriosis Phase II

More work to be done

Manufacturing

Other issues

Science

MetAp-2

Clinical trial

Trial halt

Potential markets

Conflicts with other meds

 

Timelines

What can go wrong

Main Story - Hana Biosciences (HBX)

Introduction

Table: Company statistics

Disclosures

Investment Case

Zensana

Description

Approval pathway

Competition

Royalty structure

Potential sales

Talotrexin

Anti-folate class

Current trial description

Table: NSCLC refractory/relapsed landscape

Mifepristone

Next clinical trials

Sales/market

IPdR

 

Timelines

What can go wrong

Macro Market Commentary - "It's a strange world we live in"

Biotech Monthly Coverage Updates

Adolor

Chewing gum for POI?

Table: Chewing gum solves POI

Investment case

BioMarin

Table: Basic facts for YE-2005

Table: Fiscal 2005 loss and cash balance

Table: Net product sales

Financial guidance for 2006

Table: FY-2006 loss

Table: FY-2006 net sales guidance

BH-4

Table: Milestones

Investment Case

Cortex Pharmaceuticals

Table: Development Timelines

Strategy

New management

Dendreon

Discovery Labs

Table: Basic facts

Financing picture

Table: Sources of financing

Outstanding warrants

Table: Milestones

The new Discovery Labs

ARDS lavage as a freebie

Table: ARDS scenarios

Investment case

Forbes Medi-Tech

Investment case

Genta

Investment case

Introgen

Neurochem

Table: Basic facts

Fibrellex status

Alzhemed update

Alzhemed partner

Table: Milestones

Praecis

Investment case

SciClone

Valentis

Investment case

BSR Model Portfolio Performance