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 October 2003 (v03-n10) - Anniversary Issue
See the complete outline below.
 
This is a special issue of our newsletter. We provide detailed updates on all the companies currently in our coverage universe. Weighing in at 116 pages, this is by far the largest issue we have ever done. The content goes beyond updates, however. We spoke with nearly all the management teams of 21 companies and got their view on not only where their companies were going but their expert opinion on where the biotech sector is headed. We learned some fascinating things.

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In addition to updated milestone tables for all companies, we asked each management team the following five questions:
  1. You are in a room with your peers from the other companies in our Model Portfolio. The audience will invest in only one company. Give me two or three reasons why it should be your company.
  2. What is the most important strategic decision you’ve made in the last year?
  3. Biotech valuations have increased considerably since October of 2002. Do you think the sector is overvalued? If not, what are the catalysts that will drive it higher?
  4. What are you doing between now and the end of the year to increase your company’s market cap?
  5. Does any member of the executive team currently have a hedge, collar, or similar position on your company's stock or stock options?

Find out what your CEO will be doing to increase shareholder value this year (Question 4).

Learn what top biotech executives think will drive valuations higher in the coming year (Question 3).
 
Introduction
About the format
Table: 2003 Anniversary Issue Rankings
Table: 2002 Anniversary Issue Ranking performance
Table: Model Portfolio changes in this issue
Discovery Labs (DSCO) pp. 5-10
Table: Timelines
Table: Basic Facts
Table: Publication history (10 updates since 11/2002))
Disclosure
 
Moving quietly to our top ranking
Quick Review
RDS Update
ARDS
Who is Tim Gregory?
ARDS Phase IIb
Table: ARDS Phase IIb clinical trial
Aerosolized Surfactants
Investment Case
Five Questions
 
Indevus (IDEV) pp. 11-18
 
Table: Timelines
Table: Basic Facts
Table: Publication history (10 updates since 11/2002))
Disclosure
 
Trospium
Patent red herring
Competitors trip near finish line
Competitive profile
Table: urge-incontinence drugs
It's about side effects
Rapid onset
All-important partner
Data points
Market size
Manufacturing
Pagoclone
IP-751
Pro-2000
Citocholine
Aminocandin
IP-501 and Dersalazine
 
Investment Case
Five Questions
 
Dendreon (DNDN) pp. 19-27
 
Table: Timelines
Table: Basic Facts
Table: Publication history (25 updates since 11/2002)
Disclosure
 
Timeline slippage?
Provenge partnership
9902b trial
Approval
Lack of focus?
Drifting focus
Why
going forward
Provenge
More 9901 details
PROTECT(P-11) study
Partnership
Table: Selected single-product licensing deals
Table Projected Provenge deal value
APC-8024
MAb program
DN1924
DN1921
trp-p8
APC-TR
Genentech
Geron
It's not their technology
The UBS conference hype
The scientific reality
To sum up
 
Investment Case
Five Questions
ID Biomedical (IDBE) pp. 28-34
 
Table: Timelines
Table: Basic Facts
Table: Publication history (15 updates since 11/2002)
It's only just begun
 
Why FluMist is a loser
Live virus
Bad label
Keep junior away from Grandma
Healthcare providers are not fans
Cost
Why FluINsure wins
Pieces of the virus
Label
Grandma & junior share dead virus proteins
Healthcare providers are curious
Cost
FluINsure clinical pathway
Speeding the race to approval
FluINsure partner
When is 50-50 not 50-50
ID acquisition?
Why raise $100M+
Bottom line
StreptAvax
Other programs
 
Investment Case
Five Questions
Esperion (ESPR) pp. 35-42
 
Table: Timelines
Table: Basic Facts
Table: Publication history (9 updates since 11/2002)
The Energizer bunny stock
 
The other cholesterol
ETC-216 (AIM)
Dr. Nissen's IVUS presentation
Sidebar: IVUS presentation details
Manufacturing
Pharmacia
ETC-642 (RLT peptide)
Sidebar: AHA presentation details
Manufacturing
ETC-588 (LUV)
ETC-588-004
ETC-588-005
Phase III program
Manufacturing
ETC-1001
How's it work?
Approval pathway
Is it an RLT drug?
Manufacturing
Partnership agreement(s)
The lead lining
The lawsuit against Durus
How bad could it get
 
Investment Case
Five Questions
Genta (GNTA) pp. 43-50
 
Table: Timelines
Table: Basic Facts
Table: Publication history (28 updates since 11/2002)
Timelines
  • Marketing strategy drives timelines
    • Phase III in melanoma
    Would you change anything?
    Importance of November data
    Other melanoma tidbits
    Statistical penalty or not
    Kaplan-Meier curves
    Next steps for Genasense
    Genasense at the FDA
    Ganite
     
    Investment Case
    Five Questions
    Adolor (ADLR) pp. 51-56
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (6 updates since 3/2003)
    A simple story
     
    POI
    Table: Pivotal trial descriptive data
    Study #302
    Study #313
    Study #306
    Study #308
    Clinical path
    OBD
    Chronic OBD
    Acute OBD
    Other products
    kappa-opioid analgesics
    Alvimopan+opiate combo pill
    Sterile lidocaine patch
     
    Investment Case
    Five Questions
    Nabi (NABI) pp. 57-60
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (8 updates since 11/2002)
    Back on track
     
    StaphVAX
    Phase III trial
    Attempt 2
    NicVAX
    Civacir
    Altastaph
    Other products
     
    Investment Case
    Five Questions
    Alteon (AMEX:ALT) pp. 61-63
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history 11 updates since 11/2002)
    Threading the needle
    Phase IIb SAPPHIRE/SILVER
    The next systolic trial
    LVH Phase IIb
    Money drain
    Partner postponed
     
    Investment Case
    Five Questions
    ZymoGenetics (ZGEN) pp. 64-68
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (3 updates since 12/2002)
    More cash, more smarts
     
    Products
    Recombinant human Factor XIII (rhF13)
    TACI-ig
    Recombinant human thrombin (rhThrombin)
    IL-21
    Zymo and Novo Nordisk
    Novo's hold on the pipeline
    Upcoming news flow
     
    Investment Case
    Five Questions
    Seattle Genetics (SGEN) pp. 69-72
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (8 updates since 10/2002)
    Gaining traction
     
    SGN-15
    Phase II trial
    Regulatory path
    SGN-30
    SGN-40
    SGN-35
    SGN-17/19
     
    Investment Case
    Five Questions
    Pharmos (PARS) pp. 73-75
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (1 updates since 7/2003)
    Recent developments
    Traumatic Brain Injury (TBI)
    Cognitive impairment after CABG
     
    Investment Case
    Five Questions
    SciClone (SCLN) pp. 76-79
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (5 updates since 4/2003)
    Recent developments
    Table: Recent news
    Zadaxin
    New competition for Zadaxin?
     
    Investment Case
    Five Questions
    Cortex (AMEX:COR) pp. 80-83
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (1 updates since 8/2003)
    Promising company
     
    Financing
    Spending the cash
    Product updates
    CX717
    The big indications: MCI & Schizophrenia
     
    Investment Case
    Five Questions
    Aeterna (AELA) pp. 84-88
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (6 updates since 2/2003)
    Attention grabber
     
    Neovastat
    Impavido
    Updates & Milestones
    Table: Product updates
     
    Investment Case
    Five Questions
    Sonus (SNUS) pp. 89-91
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (4 updates since 5/2003)
    A better mousetrap
     
    Funding
    Trial timeline slippage
    Clinical developments
    Partnership
     
    Investment Case
    Five Questions
    Targeted Genetics (TGEN) pp. 92-96
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (10 updates since 11/2002)
    Never count them out
     
    HIV vaccine
    Phase I
    Phase II
    What about Africa/Southern Asia
    Cystic fibrosis
    The challenge
    Phase IIb
    Rheumatoid Arthritis
    In development
    Manufacturing and money
     
    Investment Case
    Five Questions
    PAREXEL (PRXL) pp. 97-98
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (6 updates since 11/2002)
    Long-term thinking
     
    Investment Case
    Five Questions
    Introgen (INGN) pp. 99-101
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (1 updates since 8/2003)
    Advexin
    Table: Advexin pivotal trials
    Bridging therapy
    Localized therapy only
    Different target audience
    INGN-241
     
    Investment Case
    Five Questions
    AVANT Immunotherapeutics (AVAN) pp. 102-105
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (5 updates since 1/2003)
    Less talk/more action
     
    CETi-1
    Rotarix
    CholeraGarde
    Ty800
    TP10
    Manufacturing
     
    Investment Case
    Five Questions
    Onyx (ONXX) pp. 106-112
     
    Table: Timelines
    Table: Basic Facts
    Table: Publication history (6 updates since 12/2003)
    Paradise lost out
     
    Phase II RCC subgroup
    Raw data
    Table: RCC subgroup, subset of evaluable patients only
    Randomized patients
    Table: RCC subgroup, 12-week subset, randomized sub-subset
    Spontaneous remissions
    Comparisons
    Table: Comparison of RCC progression data
    RCC subgroup conclusions
    Other Phase II subgroups
    Colorectal
    Melanoma
    Other cancers
    9006 side effects
    9006 mechanism of action
    Going forward on 9006
    RCC Phase III
    More data please!
     
    Investment Case
    Five Questions
     
    Macro Market Commentary
    Storm clouds on the horizon
     
    NIBM Model Portfolio Performance
     
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