GTC Biotherapeutics (fka GTCB)

[DewDiligence]

GTCB ReadMeFirst

[Miscellaneous updates including news
flow and 2008-2009 clinical goals.]


What is GTC’s business all about?
#msg-19391437 What is the business model?
#msg-23650024 GTC’s role in Follow-On Biologics
#msg-22015291 Edited transcript from 2Q07 conference call (8/9/07)
#msg-22016210 Musings on GTC’s business-model risk
#msg-17935613 Venn diagram of business model
#msg-11752181 ATryn HD program in EU is proof of concept
#msg-9243634 Jan 2006 interview with CEO, Geoff Cox
#msg-9352093 2002 interview with Tom Newberry (dated, but still informative)
#msg-13171505 “Production of Recombinant Therapeutic Proteins in the Milk of Transgenic Animals” (recommended for the technical reader)


Valuation and finances
#msg-22017859 Liquidity and cash usage
#msg-15309465 Share count for valuation purposes
#msg-22017312 Projected ATryn sales are >$1B
#msg-22563799 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi
#msg-19227430 What is a fair price?


Upcoming events
#msg-23625805 Possible/probable news flow
#msg-23625770 Clinical, preclinical goals in 2008-2009


Management and BoD
#msg-15702541 Composition of Board of Directors
#msg-19222735 Largest shareholders as of 4/5/07
#msg-23359300 Current insider holdings
#msg-22037009 Insider buying during past year
#msg-18432652 Recent executive hires


ATryn hereditary-deficiency program in Europe
#msg-21054400 PR announcing ATryn launch
#msg-11752181 ATryn HD program in EU is proof of concept
#msg-12430822 Economics of the Leo partnership
#msg-7306242 Which antithrombin will doctors prescribe?
#msg-20873099 Sales projection for HD indication in EU
#msg-8316050 Leo Pharma partnership announcement
http://www.atiii.com What is hereditary AT deficiency? (simple)
http://tinyurl.com/yb9hl5 What is hereditary AT deficiency? (technical summary)
#msg-20330757 What is hereditary AT deficiency? (comprehensive discussion)
#msg-9502819 A patient’s story
#msg-11399356 ATryn approved by EMEA
Official product information:
#msg-11399033 (FAQ)
http://www.emea.eu.int/humandocs/PDFs/EPAR/atryn/058706en6.pdf
http://www.emea.eu.int/humandocs/PDFs/EPAR/atryn/H-587-PI-en.pdf


ATryn hereditary-deficiency program in U.S.
#msg-22567992 FDA grants Fast Track status
#msg-22560554 Likelihood of FDA approval
#msg-21999558 GTC seeks a Big Pharma partner
#msg-22008932 Musings on who the partner might be
#msg-23627036 U.S. ATryn timeline
#msg-20966468 Plasma-derived AT in U.S. is in short supply
#msg-5607789 Efficacy endpoint is clinical DVT
#msg-5609005 Design of control arm
#msg-6632420 Patient eligibility and exclusions
#msg-22563497 Risks/supply constraints of plasma-derived drugs
#msg-7306242 Which antithrombin will doctors prescribe?


ATryn DIC/sepsis program
#msg-22017312 Large addressable market for DIC/sepsis
#msg-12483101 Existing therapeutic options are weak
#msg-20150779 Scientific rationale for program (summary)
#msg-20150658 Scientific rationale for program (detailed)
#msg-21636676 Details of the phase-2 trial
#msg-23010821 How sepsis causes DIC
#msg-12480578 Sepsis incidence is on the rise
#msg-23010970 Surprising sepsis factoids
#msg-8316050 Leo Pharma partnership announcement
#msg-12430822 Economics of the Leo partnership
#msg-23627265 DIC timeline
#msg-14495208 When will GTC receive milestone payments?


Other potential uses of ATryn
#msg-20967328 Reference list of abstracts and write-ups


GTC-LFB program in Factor VIIa
#msg-13731860 Who is LFB?
#msg-13956439 Who is LFB? (addendum)
#msg-13708619 Partnership terms
#msg-15247168 How the collaboration works
#msg-16164190 Sky-high FVIIa price (rationale for GTC/LFB program);
everything you wanted to know about FVIIa in practice
#msg-21834233 NovoSeven has blockbuster status
#msg-23011014 FVIIa sales projections
#msg-13763244 Patient pool for initial indication
#msg-23650745 Reference list of FVIIa papers


GTC-LFB program for CD20 antibody
#msg-21754646 Announcement of program


Alpha-1 antitrypsin program
#msg-23011083 Rationale for program
#msg-22581060 Quick read on AAT deficiency
#msg-15170172 More background info on AAT deficiency


Miscellaneous internal and external programs
Capsule summaries of internal programs: http://www.transgenics.com/products/prod.html
#msg-23010645 GTC’s drug portfolio
#msg-20967220 Merrimack relationship
#msg-22544108 PharmAthene relationship
#msg-13797351 Grant for CD137 antibody program


Intellectual property
#msg-22560060 “Milk” patent
#msg-7179529 Purification patent
#msg-23061160 Pending patent applications
#msg-18949245 IP summary from most recent 10K report
#msg-18615705 Nuclear-transfer license from Geron
#msg-19226707 Notes on nuclear-transfer license


Existing and potential competition
(See GTC-LFB heading above for NovoSeven™ brand rFVIIa)

Plasma-derived products:
#msg-22945477 Risks/supply constraints of plasma-derived drugs
#msg-7306242 Which antithrombin will doctors prescribe?
#msg-11909951 Thrombate AT from Talecris
#msg-15898317 AT from Grifols
#msg-11829819 Prolastin AAT from Talecris
http://tinyurl.com/3dc5s9 Aralast AAT from Baxter
#msg-6488263 AAT from Purely Proteins (market-size info)
#msg-20971257 Inhaled AAT from Kamada

Non-transgenic recombinant products:
#msg-22972987 ART-123 from Artisan Pharma
#msg-15157973 Tifacogin for CAP/sepsis from NVS
#msg-22562453 Miscellaneous competition in DIC/sepsis
#msg-22016170 FVIIa analogues from Novo Nordisk
#msg-19911920 Maxygen’s Maxy-Seven
#msg-22076906 Factor V Leiden from CRXL
#msg-14176380 AM-Pharma program in sepsis
#msg-14499024 AZN/Protherics program in sepsis
#msg-15573025 Lipoxen/Baxter program in clotting factors
#msg-21761579 Second-generation CD20 program from DNA/BIIB
#msg-15652707 HuMax-CD20 from GSK/Genmab
#msg-21863730 CD20 program from InNexus Biotechnology
#msg-21653307 BioWa
#msg-23351015 Protalix
#msg-20143313 Novozymes
#msg-21123960 Inspiration Biopharmaceuticals
http://greenovation.com Greenovation

Products derived from transgenic animals:
#msg-23381254 Origen (polyclonal Ab’s from chicken eggs)
#msg-16835174 Technical issues with transgenic chickens
#msg-18396260 Roche (polyclonal Ab’s from animal serum)
#msg-15899425 Kirin / Hematech

Products derived from transgenic plants:
#msg-18566945 Risks of plant-based platforms
#msg-23627875 Biolex
#msg-15925882 SemBioSys
#msg-14191540 Prairie Plant Systems

Miscellaneous competition:
#msg-21040065 Major FoB players
#msg-19221436 ATryn vs FXa inhibitors
#msg-13169472 GlycoFi/Merck (humanized yeast glycosylation)
#msg-13222976 More on the GlycoFi story
#msg-21530514 DSM/Crucell antibody-production platform
#msg-20702138 Penn State’s mushrooms
#msg-8863527 Companies to watch


Feature stories on GTCB and transgenics
#msg-23359755 BioWorld International profiles LFB (10/07)
#msg-19726180 BioPharma Reporter (5/07)
#msg-17042733 Wired (2/07)
#msg-15920370 Managed Care (11/06)
#msg-13365243 Times of London (9/06)
#msg-13152292 Nature.com (9/06)
#msg-14278650 Biotechnology Healthcare (8/06)
#msg-12573463 Nature Biotechnology (8/06)
#msg-12273566 Boston Globe profiles Dr. Harry Meade (7/06)
#msg-11635041 Framingham, Mass. Daily News (6/06)
#msg-9243634 Red Herring (1/06)
#msg-9143261 Business Week (1/06)
#msg-8162424 Scientific American (11/05)
#msg-6806806 Wall St Transcript interview with Tom Newberry (6/05)
#msg-6775592 Newsweek special issue on healthcare (6/05)
#msg-6276428 Worcester, MA Telegram & Gazette (5/05)
#msg-7431316 Nature Biotechnology (10/04)
#msg-4057315 The Economist (9/04)