Biotech Values

[DewDiligence]

Another update…

***READ ME FIRST***

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This update includes miscellaneous items from the past two weeks, including the recent management change, the IND filing in AMD, and musings on IL-9. A notable addition to the “STUFF YOU SHOULD KNOW about the FDA” section is #msg-2515496.


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Capsule summary from GENR website [somewhat out of date]: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

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-2703251

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

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


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STUFF YOU SHOULD KNOW about the FDA

Established clinical endpoints for AMD drugs:
#msg-2515496

Special Protocol Assessment:
#msg-1604114
#msg-2399184
#msg-2544508

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://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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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

3/25/04 news (U.S. IND filed):
#msg-2688827
#msg-2682374

Possible design of future trials:
#msg-2686192
#msg-2321873
#msg-2321943
#msg-2606332

Development timeline:
#msg-2173835

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

Safety profile:
http://clincancerres.aacrjournals.org/cgi/content/abstract/9/7/2465

Potential in diabetic retinopathy:
#msg-1932994
#msg-1923471

Musings on odds of program’s success:
http://tinyurl.com/ywdk8


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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
Pfizer-Eyetech development deal:
#msg-1896215

Lucentis:
Phase-2 data (8/16/03):
http://tinyurl.com/37h8f
http://tinyurl.com/29h6g
Phase-3 inflammation and 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 trial in dry AMD:
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:
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
3/25/04 update:
#msg-2689161

Visudyne:
Recent reimbursement changes:
#msg-2244539

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

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

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

Bausch & Lomb drops AMD program:
#msg-2341249

Regeneron’s VEGF-Trap:
isolution’s musings:
#msg-1920811
Start of phase-1 trial:
#msg-2553391
Background info on the company from Dew’s point of view:
#msg-2653624

InnoRx’s implant:
#msg-2346091


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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


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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

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
Patent issued:
#msg-2203845

Trodulamine

#msg-1662857
#msg-1667873


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MISCELLANEOUS BIOTECH TOPICS

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

Ethical issues in overseas trials:
#msg-2541448

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


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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