Biotech Values

[DewDiligence]

***READ ME FIRST***

This update includes the new insider holdings (from the 2004 incentive plan) and the 1Q04 quarterly financials. Also in this update are the recent Squalamine abstract in retinopathy (#msg-3090764), musings on the placebo effect (or lack thereof) #msg-3050146).

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Feedback is welcomed on any subject.

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OVERVIEW of GENAERA

Capsule summary from GENR website [somewhat out of date]:
http://www.genaera.com/backgrounder.html

Overview slides from GENR website:
http://www.genaera.com/investorinfo.html# [click bottommost link]

Corporate summary from Reuters:
http://tinyurl.com/2972m

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RECENT WEBCASTS

4/22/04: GENR’s CC on the development program in AMD (52 minutes):
http://www.vcall.com/CustomEvent/NA011359/index.asp?ID=87897

4/22/04 conference-call slides:
http://www.sec.gov/Archives/edgar/data/880431/000119312504068079/dex992.htm

4/22/04 conference-call highlights:
#msg-2916397

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GENRAERA’S VALUATION

Analysis by Jason Kantor (WR Hambrecht)
4/23/04 report:
http://wrhambrecht.com/sector/biotech/notes/genr20040423.pdf
Errata:
#msg-3078062

Analysis by Dew
12/21/03 post:
#msg-1981262
1/22/04 addendum:
#msg-2188262

Size of addressable market
Wet AMD:
#msg-1832330
Diabetic retinopathy:
#msg-2824580

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ARTICLES about GENAERA

5/7/04 Signals Magazine:
#msg-3040295

2/7/04 Ophthalmology Management:
#msg-2321887

12/8/03 Forbes:
#msg-1894668

8/6/03 Reuters:
#msg-1831701

5/21/03 CBS [oldie but goodie]:
#msg-1903371

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MANAGEMENT and OWNERSHIP

Officer/director bios:
http://www.genaera.com/management.html

Officer/director shareholdings:
#msg-3069875

3/26/04 management changes:
#msg-2692534
#msg-2700495

Profile of newest director, Osagie Imasogie:
#msg-2097691

Largest GENR shareholders (as of 3/19/04):
#msg-2717157

The Scientific Advisory Board:
#msg-2923085

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FINANCES:

Shelf registration and financing history:
#msg-2909211

Latest quarterly report (1Q04):
http://biz.yahoo.com/prnews/040510/nym098_1.html

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STUFF YOU SHOULD KNOW about the FDA

Definitions of changes in visual acuity:
#msg-2955983

Established clinical endpoints:
#msg-2515496 (AMD)
#msg-3010651, #msg-3026282 (DME)

Special Protocol Assessment (SPA):
#msg-1604114
#msg-2399184
#msg-2544508

Fast Track, Accelerated Approval, and Orphan status:
#msg-1643465
#msg-3041879
#msg-3044772 (Signals magazine)
#msg-2540946

Continuous Marketing Application (CMA):
#msg-2319622

The not “new” FDA:
#msg-2989501

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SQUALAMINE in AMD

Dew’s projected timeline:
#msg-3041673
#msg-3041879

Reasons to be optimistic:
http://tinyurl.com/ywdk8
#msg-3050146

U.S. phase-2 trials

5/4/04 press release announcing start of first U.S. trial:
#msg-3006307
4/22/04 press release on FDA acceptance of phase-2 plans:
#msg-2914787
4/22/04 conference-call highlights:
#msg-2916397
Musings on the phase-2 trial designs (VEGF Burst):
#msg-2920654
Musings on the compressed clinical timeline:
#msg-2913400
Dosing schedule and expectations in the main phase-2 trial:
#msg-2939783
Combination therapy with Visudyne:
#msg-2922504
Size of future phase-3 trials:
#msg-2321943

Phase-1/2 trial in Mexico

Clinical data (10/07/03 press release):
http://www.genaera.com/pressreleases/2003_oct7.html
Accompanying Slides:
#msg-1605364
Dosing regimen:
#msg-1806532
Lack of placebo effect:
http://tinyurl.com/356zt
Rationale for conducting trial in Mexico:
#msg-1617005

Squalamine’s safety profile
http://clincancerres.aacrjournals.org/cgi/content/abstract/9/7/2465
http://tinyurl.com/33huk

Manufacturing
http://www.genaera.com/pressreleases/2003_aug27.html
http://tinyurl.com/2usnn

Potential in diabetic retinopathy
#msg-3090764
#msg-3026282

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COMPETITION in AMD

Macugen

Phase-3 AMD data:
#msg-1967290
Pfizer-Eyetech development deal:
#msg-1896215
Phase-2 DME data:
#msg-3003683
Poke, poke, ka-ching:
#msg-3020521
NY Times article:
#msg-1765925
Forbes article:
#msg-1894668
Dew’s reply to Forbes:
#msg-1895478

Lucentis

Phase-2 data (8/16/03):
http://tinyurl.com/37h8f
http://tinyurl.com/29h6g
Phase-3 inflammation and enrollment delays:
#msg-2541474
#msg-2569865
#msg-2801681
isolution on the mechanism of action:
#msg-1776880
Novartis licenses ex-U.S. rights:
http://tinyurl.com/yphpe

Alcon’s Retaane

Phase-2 data in wet AMD (8/18/03):
http://tinyurl.com/2bmlq
Update from 2/12/04 CC:
#msg-2386487
Planned 5-year trial in dry AMD:
http://tinyurl.com/22zp3

Oxigene’s CA4P

Phase-1/2 AMD trial at Johns Hopkins:
#msg-1843928
Treatment of one patient with myopic degeneration:
#msg-2030536
#msg-1904720
Dew’s rationale for selling (1/21/04):
#msg-2178433
#msg-2197073
Update from 2/12/04 CC:
#msg-2366802
Is QTc-prolongation impeding enrollment?
#msg-2517117
3/25/04 update:
#msg-2689161
OXi4503 (the successor to CA4P):
#msg-3025052

Regeneron’s VEGF-Trap

Start of phase-1 trial in AMD:
#msg-2553391
Status in cancer:
#msg-2842624
isolution’s musings:
#msg-1920811
Background info on the company from Dew’s point of view:
#msg-2653624

Visudyne

U.S. reimbursement expansion:
#msg-2244539
Reimbursement and clinical data in Japan:
#msg-2922875
Comments on the data:
#msg-2934019
Latest QLTI conference call:
#msg-2957500

Miravant’s SnET2 (a Visudyne knockoff):
#msg-2957661
#msg-2732938

Acuity’s siRNA:
http://biz.yahoo.com/prnews/040218/nyw039_1.html
#msg-2418606

Genvec’s AdPEDF:
#msg-1929215
#msg-2086311

Allergan’s Posurdex, AGN-6, and oral Tazarotene:
#msg-2276173

Oxford Biomedica licenses gene targets from ENMD:
#msg-1866203

InnoRx’s implant:
#msg-2346091

Peregrine Pharmaceuticals starts preclinical testing:
#msg-2964469

Bausch & Lomb drops AMD program:
#msg-2341249

TLCV’s Rheopheresis for dry AMD:
#msg-2404229

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ANTI-ANGIOGENESIS and VTA MECHANISMS of ACTION

Guru Mark Z. explains how Squalamine’s mechanism differs from VEGF inhibitors:
http://tinyurl.com/27fqx
http://tinyurl.com/2kn32

Squalamine’s M.O.A. in retinopathy:
#msg-3090764

Comparisons of various mechanisms of action (PPHM press release):
#msg-2316560

Recent research on VTA combination therapy:
#msg-3087247

Anti-angiogenesis as a cancer prophylactic?
#msg-2491306

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TOXICITY and METHOD of DELIVERY

Squalamine’s safety profile:
http://clincancerres.aacrjournals.org/cgi/content/abstract/9/7/2465

Frequently asked questions about QTc-prolongation:
http://tinyurl.com/3dlul

FDA drafts on QTc-prolongation [for technical nerds only]:
http://www.fda.gov/OHRMS/DOCKETS/AC/03/briefing/3956B1_02_FDA-Preliminary%20Concept.htm
#msg-2552640

isolution on importance of local delivery:
#msg-1799081

isolution on invasive vs non-invasive local delivery:
#msg-2399265

Iontophoresis:
#msg-2853704
#msg-2418741

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SQUALAMINE in CANCER

The crowded cancer-drug arena:
#msg-2789976

Phase-2 trial in lung cancer:
#msg-2863014 (GENR PR)
#msg-2886399 (musings)
#msg-2887797 (musings)

Phase-2 trial in prostate cancer:
#msg-1886712

Preclinical research in breast cancer:
http://www.genaera.com/pressreleases/2003_aug11.html

Phase-2 trial in ovarian cancer (5/20/02):
http://www.sec.gov/Archives/edgar/data/880431/000095010902003102/dex992.txt
[Further development in ovarian cancer was suspended in August 2002 to conserve funding for other programs]

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OTHER DRUGS in GENR’S PIPELINE

Anti-IL-9 antibody for asthma

Status of IL-9 program:
#msg-2700495
MedImmune licenses IL-9 from GENR (April 2001):
http://investor.medimmune.com/phoenix.zhtml?c=83037&p=IROL-NRText&t=Regular&id=366218&am....
General IL-9 patent:
http://www.genaera.com/pressreleases/2003_aug7.html
IL-9-vaccine patent:
http://www.genaera.com/pressreleases/2003_nov13.html
Renewal of research agreement with Ludwig Institute:
#msg-2545526

Lomucin for cystic fibrosis

Phase-2 results:
http://www.genaera.com/pressreleases/2003_oct16A.html
drbio’s commentary on results:
#msg-1603851
Dew’s commentary on results:
#msg-1603511
GENR’s mucoregulator patent:
http://biz.yahoo.com/prnews/040407/nyw050_1.html
Competition from Inspire Pharmaceuticals:
#msg-2955055
Competition from DYAX:
#msg-2455510

Trodulamine

#msg-1662857
#msg-1667873

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MISCELLANEOUS BIOTECH TOPICS

The Scirus search engine:
#msg-2812639

Cancer stem cells: a potential breakthrough discovery:
#msg-2482896

Fortune magazine on what’s wrong with the War On Cancer:
#msg-2562313

Patentability of “natural” compounds:
#msg-1751021

Biowatch’s musings on biotech patents:
#msg-2099834

The demographic tail wind pushing biotechnology:
#msg-2351794

Poisson arrivals and Genentech’s colossal valuation:
#msg-2486205

Musings on generic biologics:
#msg-2382560
#msg-3032828

The asthma riddle:
#msg-2834998

Two articles on obesity drugs
Business 2.0 article:
#msg-2460720
Reuters on the backlash from HMOs:
#msg-2656671

Two provocative articles in the NY Times
Drug-eluting stents:
#msg-2651321
Alzheimer’s disease:
#msg-2797088

The epidemic of heart disease in the third world:
#msg-2934280

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AMD: THE DISEASE

Simulation of vision with varying degrees of AMD:
http://www.my-vision-simulator.com/macular_degeneration/

General description of macular degeneration [includes four-minute audio clip]:
http://www.mdsupport.org/library/md_description.html

Wet AMD is self-limiting:
http://tinyurl.com/2j4af

AMD gene discovery:
#msg-1616555

New research on AMD biomarker:
#msg-3088575

Anatomy of the Eye:
http://www.mdsupport.org/anatomy.html

Glossaries of ophthalmic terms:
http://www.mdsupport.org/glossary.html
http://www.blindness.org/research/glossary.asp