Replies to post #6791 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

GTCB ReadMeFirst

[Updates on various subjects: musings on non-inferiority
delta of US ATryn trial; LFB collaboration in Factor IX;
MoA of AT-heparin binding; new speculation on the US
ATryn partner; musings on the US ATryn price; new info
on size of sepsis market; value of GTC’s NOL’s; musings
on a hostile takeover; new antithrombin abstracts.]


What is GTC’s business all about?
#msg-19391437 What is the business model?
#msg-25258201 GTC’s role in Follow-On Biologics
#msg-24216158 Edited transcript from 3Q07 conference call (11/1/07)
#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 informative)
#msg-13171505 Technical paper on the science of transgenics


Valuation and finances
#msg-24185216 3Q07 results (cont’d in #msg-24185359)
#msg-24185359 Cash guidance for 4Q07
#msg-24216158 Sufficient cash to get into 2H08 (scan halfway down)
#msg-15309465 Share count for valuation purposes
#msg-22017312 Projected ATryn sales are >$1B
#msg-25521081 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi
#msg-25281364 What is a fair price?
#msg-25908563 How to value GTC’s net-loss carryforward
#msg-25377457 Hostile takeover highly unlikely


Upcoming events
#msg-25796696 Possible/probable news flow
#msg-24323901 Clinical, preclinical goals in 2008-2009


Management and BoD
#msg-25257085 Composition of Board of Directors
#msg-19222735 Largest shareholders as of 4/5/07
#msg-25610590 Current insider holdings
#msg-25370967 Recent insider transactions
#msg-18432652 Recent executive hires


ATryn hereditary-deficiency program in Europe
#msg-24802503 Leo PR on ATryn launch in UK
#msg-11752181 ATryn HD program in EU is proof of concept
#msg-12430822 Economics of the Leo partnership
#msg-24708726 ATryn has a premium price
#msg-24712198 ATryn warrants a premium price
#msg-24709713 Official UK product specs
#msg-20873099 Sales projection for HD indication in EU
#msg-8316050 Leo Pharma partnership announcement
http://www.atiii.com What is hereditary antithrombin deficiency? (simple)
#msg-20330757 What is hereditary antithrombin deficiency? (detailed)
#msg-9502819 A patient’s story
#msg-11399356 ATryn approved by EMEA
#msg-11399033 EMEA answers to FAQ
EMEA scientific discussion
EMEA product specs


ATryn hereditary-deficiency program in U.S.
#msg-25953814 U.S. ATryn timeline
#msg-25164757 FDA grants ATryn an Orphan Drug designation
#msg-25173071 Significance of the orphan designation
#msg-25307567 Handicapping the phase-3 results (general)
#msg-25866013 Handicapping the phase-3 results (NI delta)
#msg-25943427 Survey results on the US partnership
#msg-25943427 Speculation on the US partner
#msg-20966468 Plasma-derived AT in U.S. is in short supply
#msg-24751863 Sales projection for HD indication in EU
#msg-25131684 Efficacy endpoint is symptomatic DVT
#msg-5609005 Design of control arm
#msg-24957373 Patient eligibility and exclusions
#msg-24957326 How long are patients observed?
#msg-23864419 Risks/supply constraints of plasma-derived drugs


ATryn DIC/sepsis program
#msg-22017312 Large addressable market for DIC/sepsis
#msg-25873575 Ditto
#msg-25222553 Existing therapeutic option (Xigris) is weak
#msg-25214176 Scientific rationale for program (summary)
#msg-20150658 Scientific rationale for program (detailed)
#msg-25154549 Musings by dewophile
#msg-21636676 Details of the phase-2 trial
What is disseminated intravascular coagulation?
#msg-23010821 How sepsis causes DIC (simple version)
#msg-25154486 How sepsis causes DIC (detailed, for science nerds only!)
#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-25875407 Musings on the ATryn price #msg-25325852 Rough DIC timeline
#msg-14495208 When will GTC receive milestone payments?


Miscellaneous info on antithrombin
#msg-25954327 Auxiliary reference list of antithrombin papers
#msg-25319336 Role of AT in the MoA of heparin/LMWH


GTC-LFB program in Factor VIIa
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-24176938 NovoSeven has blockbuster status
#msg-23011014 FVIIa sales projections
#msg-14084250 FDA approves NovoSeven in acquired hemophilia
#msg-13763244 Patient pool for initial indication
#msg-25325878 Reference list of FVIIa papers


Alpha-1 antitrypsin program
#msg-23011083 Rationale for program
#msg-22581060 Quick read on AAT deficiency
#msg-15170172 More background on AAT deficiency
#msg-24192571 Musings on orphan-drug exclusivity


Miscellaneous internal and external programs
#msg-24879769 GTC’s drug portfolio
Capsule summaries of internal programs
#msg-25039843 ProGenetics (FIX, FVIII, fibrinogen)
#msg-25875091 LFB joins FIX program
#msg-21754646 CD20 antibody program with LFB
#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-24353741 Pending patent applications
#msg-18949245 IP summary from most recent 10K report
#msg-25410579 Musings on fibrinogen IP
#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-23864419 Risks/supply constraints of plasma-derived drugs
#msg-11909951 Thrombate AT from Talecris
#msg-15898317 AT from Grifols
#msg-11829819 Prolastin AAT from Talecris
http://alpha1health.com Aralast AAT from Baxter
#msg-6488263 AAT from Purely Proteins (market-size info)
#msg-23901417 Inhaled & injected AAT from Kamada
#msg-25174719 Musings on Kamada’s orphan designation
#msg-25848126 Ditto

Non-transgenic recombinant products:
#msg-22972987 ART-123 from Artisan Pharma
#msg-25222553 Xigris
#msg-15157973 Tifacogin for CAP/sepsis from NVS
#msg-22562453 Miscellaneous competition in DIC/sepsis
#msg-25259635 FVIIa analogues from Novo Nordisk
#msg-19911920 Maxygen’s Maxy-Seven
#msg-25188594 CSL’s albumin-FVIIa conjugate
#msg-25800123 Baxter Factor IX programs
#msg-25447561 Baxter-NKTR pegylated clotting factors
#msg-15573025 Baxter-Lipoxen clotting factors
#msg-22076906 Factor V Leiden from CRXL
#msg-14176380 AM-Pharma program in sepsis
#msg-14499024 AZN/Protherics program in sepsis
#msg-21761579 Second-generation CD20 program from DNA/BIIB
#msg-24683024 HuMax-CD20 from GSK/Genmab
#msg-21863730 CD20 program from InNexus Biotechnology
#msg-25325807 Overview of CD20 programs (20-min video)
#msg-23821925 BioWa / Kyowa Hakko
#msg-24264196 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-24872146 Risks of plant-based platforms
#msg-25261188 Biolex (CD20 program)
#msg-15925882 SemBioSys
#msg-14191540 Prairie Plant Systems
#msg-25520143 Medicago

Miscellaneous:
#msg-21040065 Major FoB players
#msg-24139996 ATryn vs FXa inhibitors
#msg-24140012 Lovenox doesn’t work for AT HD
#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


Feature stories on GTCB and transgenics
#msg-23866167 Contract Pharma (10/07)
#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)