Replies to post #1487 on Biotech Values

[MatrixMan]

What a phenomenal review! I thank you for putting all of that information together for us all in one place! Very nice.

[DewDiligence]

Another update…

***READ ME FIRST***

A pointer to this post 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 display it by clicking on the appropriate link.)

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.


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Capsule summary from GENR website [somewhat out of date]: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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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]


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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


---------------------------------------------------------------------------------------------------------
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