Biotech Values

[DewDiligence]

***READ ME FIRST***

This update includes new developments in the Squalamine program in AMD, including the 4/23/04 conference call, press releases, and musings on the phase-2 program. Also new in this update are info about the Scientific Advisory Board, the shelf registration, the FDA’s definitions of changes in visual acuity, additional details on competitors in AMD and CF, and musings on the Squalamine trial in lung cancer.

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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Capsule summary from GENR website [somewhat out of date]: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

By Jason Kantor, WR Hambrecht & Co (4/23/04):
http://wrhambrecht.com/sector/biotech/notes/genr20040423.pdf

By Dew (12/21/03, updated 1/22/04):
#msg-1981262
#msg-2188262

Size of addressable market in wet AMD:
#msg-1832330

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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-2703251

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 (4Q03):
http://biz.yahoo.com/prnews/040325/nyth064_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-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

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
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-2824580
#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

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

Biowatch explains how VEGF inhibition works:
#msg-1688172

Mark Z. explains how Squalamine’s MOA is distinct from other VEGF inhibitors:
http://tinyurl.com/27fqx
http://tinyurl.com/2kn32

NIH site on angiogenesis:
http://press2.nci.nih.gov/sciencebehind/angiogenesis/angio00.htm

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

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