Biotech Values

[DewDiligence]

It’s finally arrived…

***READ ME FIRST***

This information packet will be updated periodically. A pointer to the latest version will be kept in the iBox at the top of your message-board page. (If you are currently hiding the iBox, you can enable the option to show it by clicking on the appropriate link.)

Feedback is welcomed and expected. Special thanks to Biowatch and cadpdvr for helping to compile this info.

Please post about any errors or problems you encounter, such as expired links. Enjoy!

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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Capsule summary from GENR website [somewhat out of date]: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://yahoo.investor.reuters.com/FullDesc.aspx?target=/stocks/quickinfo/companyprofile/fulldescript....


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RECENT WEBCASTS

2/25/04: The Eyes Have It at Bio-CEO conference [85 minutes]:
http://www.firstcallevents.com/service/ajwz400193770gf12.html
Commentary on webcast by Dew:
#msg-2541474

2/3/04: Roy Levitt’s interview with ceocast.com [20 minutes, free registration required]:
http://www.ceocast.com/company.cfm?cid=13897&n=053827

1/15/04 presentation at JP Morgan conference [30 minutes, available until 4/18/04]:
http://www.mapdigital.com/jpmorgan/healthcare04/ondemand.html?archives=windowsmedia#g


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GENRAERA’S VALUATION

By Jason Kantor, WR Hambrecht & Co (2/26/04):
http://www.wrhambrecht.com/sector/biotech/notes/genr20040226.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

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-2514386

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


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STUFF YOU SHOULD KNOW about the FDA

Special Protocol Assessment:
#msg-1604114
#msg-2399184

Fast Track, Accelerated Approval, and Orphan status:
#msg-1643465
#msg-2540946


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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://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=7077012&tid=magn&sid=707....

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


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SQUALAMINE in AMD

Data from phase-1/2 trial:
Press release: http://www.genaera.com/pressreleases/2003_oct7.html
Slides: #msg-1605364

Dosing regimen in phase-1/2 trial:
#msg-1806532

Rationale for conducting trials in Mexico:
#msg-1617005

Probable design of future trials:
http://tinyurl.com/3fzex
#msg-2321873
#msg-2321943

Development timeline:
#msg-2173835


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COMPETITION in AMD

Macugen:
Phase-3 data:
#msg-1967290
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 enrollment delays:
http://tinyurl.com/3gl55
#msg-2541474
isolution on the mechanism of action:
#msg-1776880
Novartis licenses ex-U.S. rights:
http://tinyurl.com/yphpe

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 trials in dryAMD:
http://tinyurl.com/22zp3

CA4P:
Phase-1/2 AMD trial at Johns Hopkins:
#msg-1843928
Calgary Herald on treatment of patient with myopic degeneration:
#msg-2030536
mid_swe’s OXGN website [very thorough]:
http://www.geocities.com/mid_swe/oxgn.html
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
Update from 3/04/04 Lehman webcast:
#msg-2523848

Visudyne:
Recent reimbursement changes:
#msg-2244539

Allergan’s pipeline (Posurdex, AGN-6, and Tazarotene):
#msg-2276173

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

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

Bausch & Lomb drops AMD program:
#msg-2341249

Regeneron’s VEGF-Trap:
#msg-1920811

InnoRx’s implant:
#msg-2346091


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TOXICITY and METHOD of DELIVERY

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

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

isolution on importance of local delivery:
#msg-1799081

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

chumpplayer’s musings on AREDS study and cardiac toxicity:
http://tinyurl.com/2hr22


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SQUALAMINE in CANCER

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

Phase-2 trial in lung cancer [scan to end of documents]:
http://www.genaera.com/sec_reports/8-K_NSCLC%20Results.pdf
http://www.genaera.com/sec_reports/8-K_Squalamine%20Trial.pdf

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:
Medimmune licenses IL-9 from GENR:
http://investor.medimmune.com/phoenix.zhtml?c=83037&p=IROL-NRText&t=Regular&id=366218&am....
IL-9 patent issued:
http://www.genaera.com/pressreleases/2003_aug7.html

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
Patent issued:
#msg-2203845

Trodulamine for obesity:
#msg-1662857
#msg-1667873


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MISCELLANEOUS BIOTECH TOPICS

Patentability of “natural” compounds:
#msg-1751021

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

The demographic tail wind pushing biotechnology:
#msg-2351794

Dew’s musings on generic biologics:
#msg-2382560

Ethical issues in overseas trials:
#msg-2541448


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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