Replies to post #14359 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

GTCB ReadMeFirst

[Updates:
3Q08 financials;
proposed financing from LFB;
info re GTC’s Nasdaq listing;
transcript of 3Q08 CC;
PharmAthene financials and Protexia guidance;
possible/probable news flow in 2008-2009;
revised program-timeline chart;
miscellaneous updates on competing programs;
Nature Biotechnology article on difficulty gaining traction vs plasma-derived drugs;
revised table of recent biotech buyouts.]


What is GTC’s business all about?
#msg-19391437 What is the business model?
#msg-28895121 GTC’s role in Follow-On Biologics
#msg-22016210 Musings on GTC’s business-model risk
#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
#msg-33563171 Conference-call transcripts 2005-present


Valuation and finances
#msg-33291062 Proposed financing from LFB
#msg-33296841 Why the 6/1/08 cutoff date for loan redemption?
#msg-33298466 GTC is effectively a call option
#msg-33294645 3Q08 financial results
#msg-26650518 Feb 2008 financing transaction
#msg-27519023 Diluted share count for valuation purposes
#msg-25908563 How to value GTC’s net-loss carryforward
#msg-32927810 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi
#msg-26164147 Valuation comparator: CoGenesys
#msg-31335809 Exercise prices of officers’ options
#msg-31338415 Aggregate compensation in event of buyout
#msg-13857945 Hostile takeover unlikely
#msg-25377457 Poison pill
#msg-33209541 Table of recent biotech buyouts


GTC’s Nasdaq listing
#msg-33238369 4/20/09 deadline to raise share price to $1
#msg-33475481 GTC in violation of minimum net worth


News flow
#msg-33564484 Possible/probable events in 2008-2009
#msg-33482901 Clinical, preclinical goals in 2009


Management and BoD
#msg-28839475 Composition of Board of Directors
#msg-32520988 Current insider holdings
#msg-29259854 Insider transactions since mid 2006
#msg-27656417 Largest shareholders


ATryn hereditary-deficiency program in U.S.
#msg-31925007 BLA receives FDA priority review
#msg-30191066 GTC partners with Ovation Pharmaceuticals
#msg-30192756 Comments on the Ovation deal
#msg-33411986 When will Ovation pay milestones?
#msg-30252905 Effective royalty rate from Ovation
#msg-26535139 Phase-3 study meets primary endpoint
#msg-29156083 US ATryn timeline
#msg-25164757 FDA grants Orphan Drug designation
#msg-25173071 Significance of the orphan designation
#msg-30140794 ATryn has never shown immunogenicity
#msg-20966468 Plasma-derived AT in US is in short supply
#msg-29898480 Plasma-derived AT in US will stay in short supply
#msg-30789679 Risks/supply constraints of plasma-derived drugs
#msg-27253453 Musings on the ATryn price
#msg-24751863 Sales projections for HD indication
#msg-30196061 Ovation’s own PR on the deal with GTC
#msg-30191214 Ovation’s product portfolio
#msg-32277212 FDA draft guidance on transgenic animals


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-32796138 Difficulty gaining traction vs plasma-derived drugs
#msg-8316050 Leo Pharma partnership announcement
#msg-12430822 Economics of the Leo partnership
#msg-31512215 When will Leo (LFB) pay milestones?
#msg-27253453 Musings on the ATryn price
#msg-26883688 What is hereditary AT deficiency? (see bottom)
#msg-9502819 A patient’s story
#msg-24709713 Official UK product specs
#msg-26144771 Official EMEA docs on ATryn in HD


ATryn DIC/sepsis program
DIC summary from GTC’s website
#msg-31288582 Rough DIC timeline
#msg-22017312 Large addressable market (1)
#msg-25873575 Large addressable market (2)
#msg-26910150 Large addressable market (3)
#msg-25222553 Existing therapeutic option (Xigris) is weak
#msg-25214176 Scientific rationale for program (summary)
#msg-26145421 Scientific rationale for program (detailed)
#msg-12430822 Economics of the Leo partnership
#msg-21636676 Details of phase-2 trial
#msg-25154549 Musings by dewophile
#msg-26123066 Musings by Dew
#msg-25154486 How sepsis causes DIC (detailed, for science nerds only!)
#msg-27219642 How sepsis causes DIC (simplified view)
#msg-27253453 Musings on the ATryn price
#msg-31512215 When will LFB (formerly Leo) pay milestones?
#msg-33411986 When will Ovation pay milestones?


CABG/HR and other potential indications for ATryn
#msg-30546734 Why Ovation is interested in CABG/HR indication
#msg-30579599 Size of addressable market in CABG/HR
#msg-29794528 CABG musings by ‘rustyboy’
#msg-30763768 Economics of potential program by Leo
#msg-29022959 Venn diagram of potential acquired-deficiency indications
#msg-28247660 ATryn is not the Holy Grail


Miscellaneous info on antithrombin and coagulation disorders
#msg-31514433 Reference list of antithrombin papers
Wikipedia entry on antithrombin
Highly technical paper on hereditary AT deficiency


GTC-LFB program in Factor VIIa
#msg-13956439 Who is LFB?
#msg-13708619 Partnership terms
#msg-15247168 How the collaboration works
#msg-30472398 Rationale for program
#msg-27139814 Treating hemophiliacs w/inhibitors is economically justified
#msg-31300413 FVIIa has blockbuster sales already…
#msg-29656551 …and even larger sales are expected
#msg-13763244 Patient pool for GTC’s initial indication
#msg-14084250 FDA approves NovoSeven in acquired hemophilia
#msg-31635948 Reference list of FVIIa papers
#msg-29368265 Background info on FVIIa


Alpha-1 antitrypsin program
#msg-26909835 Rationale for AAT program
#msg-27651137 Ditto
#msg-29124752 LFB to collaborate on AAT 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
Capsule summaries of internal programs
#msg-25039843 ProGenetics collaboration
#msg-25875091 LFB joins Factor IX program
#msg-33562839 PharmAthene’s Protexia
#msg-26909850 Rationale for CD137 program
#msg-13797351 SBIR grant for CD137 program
#msg-21754646 CD20 (Rituxan FoB) program
#msg-27669524 Genentech patents relevant to CD20 program
#msg-27456445 Musings on unnamed FoB’s


Intellectual property
#msg-22560060 “Milk” patent
#msg-7179529 Purification patent
#msg-30114144 Recent patent applications (1)
#msg-32623756 Recent patent applications (2)
#msg-30906664 Patent application re ADCC
#msg-18949245 IP summary from most recent 10K report
#msg-30254756 Pharming licenses GTC’s fibrinogen IP
#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-30789679 Risks/supply constraints of plasma-derived drugs
#msg-11909951 Thrombate AT from Talecris/CSL
#msg-15898317 AT from Grifols
#msg-27011864 Prolastin AAT from Talecris/CSL
#msg-30950932 Inhaled Prolastin gets EU orphan designation
#msg-33117744 Kamada injectable AAT
#msg-32818472 Kamada inhaled AAT
http://alpha1health.com Aralast AAT from Baxter
#msg-6488263 AAT from Purely Proteins (market-size info)
#msg-30866107 Plasma-derived fibrinogen from CSL

Non-transgenic recombinant products:
#msg-27669307 Recent improvements in cell-culture yield
#msg-27043616 ART-123 from Artisan Pharma
#msg-25222553 Xigris
#msg-15157973 Tifacogin for CAP/sepsis from NVS
#msg-27187973 Paion’s Solulin (thrombomodulin)
#msg-14176380 AM-Pharma program in sepsis
#msg-26162978 AZN/Protherics program in sepsis
#msg-22562453 Miscellaneous competition in DIC/sepsis
#msg-27193231 Arriva inhaled AAT program
#msg-32247061 FVIIa analogs from Novo Nordisk
#msg-30422488 Bayer’s FVIIa analog (from Maxygen)
#msg-33129028 Catalyst Biosciences FVIIa
#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-29671205 Factor IX-Fc from Biovitrum / BIIB
#msg-29801165 Porcine FVIII from Ipsen
#msg-21761579 2nd-generation CD20 program from DNA/BIIB
#msg-32614554 2nd-generation CD20 program from Roche/GlycArt
#msg-24683024 Genmab’s Ofatumumab in RA
#msg-31140694 Ofatumumab works in CLL
#msg-28770646 CD20 program from InNexus Biotechnology
#msg-32767969 Overview of CD20 programs (article)
#msg-25325807 Overview of CD20 programs (video)
#msg-32744885 BioWa
#msg-20143313 Novozymes
#msg-21123960 Inspiration Biopharmaceuticals

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-28795730 Nature profile of plant platforms
#msg-32693787 Biolex (including CD20 FoB program)
#msg-31043957 SemBioSys submits insulin IND
#msg-15925882 SemBioSys to use 505(b)(2) pathway
#msg-32496700 Plant-based FoB’s from Nomad Bioscience
#msg-32496592 Tobacco program from Bayer
#msg-24264196 Protalix
#msg-14191540 Prairie Plant Systems

Miscellaneous:
#msg-21040065 Major FoB players
#msg-28231986 Quick primer on Atryn vs other anticoagulants
#msg-26911313 ATryn vs FXa inhibitors
#msg-13169472 GlycoFi/Merck (humanized yeast glycosylation)
#msg-13222976 More on the GlycoFi story
#msg-30027903 DSM/Crucell antibody-production platform
#msg-28681472 Agennix’s Talactoferrin from fungus
#msg-20702138 Penn State’s mushrooms
#msg-27669307 Improvements in bioreactor yields


Feature stories on GTCB and transgenics
#msg-32796138 Nature Biotechnology (10/08)
#msg-29928070 Banal article from salon.com (6/08)
#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)