Replies to post #11340 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

GTCB ReadMeFirst

[Updates:
ATryn has never shown immunogenicity,
banal article from salon.com,
CABG musings by ‘rustyboy’,
FVIIa analogues from Novo Nordisk,
GTC’s pending patent applications,
links to old CC transcripts,
MAXY starts Maxy-Seven trial,
Merrimack gets $60M funding,
increased production yields from DSM/Crucell,
new reference lists for ATryn and FVIIa abstracts,
NVS licenses ADCC platform from BioWa,
Pharming’s US phase-3 data,
porcine FVIII from Ipsen,
Thrombate supply not increasing.]


What is GTC’s business all about?
#msg-29148987 Edited transcript from 1Q08 conference call (5/8/08)
#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-29863430 Links to all conference-call transcripts since 3Q06


Valuation and finances
#msg-29133665 Notes from 1Q08 conference call
#msg-29125372 1Q08 financial results
#msg-29174382 Accounting for ATryn on GTC’s income statement
#msg-29133935 Cash balance and expected cash burn
#msg-27519023 Diluted share count for valuation purposes
#msg-26650518 Latest financing transaction
#msg-25908563 How to value GTC’s net-loss carryforward
#msg-22017312 Projected ATryn sales are >$1B
#msg-30170933 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi
#msg-26164147 Valuation comparator: CoGenesys
#msg-13857945 Hostile takeover unlikely
#msg-25377457 Poison pill


News flow
#msg-29136128 Possible/probable events in 2008-2009
#msg-29656296 Clinical, preclinical goals in 2008-2009


Management and BoD
#msg-28839475 Composition of Board of Directors
#msg-28839364 Current insider holdings
#msg-29259854 Insider transactions since mid 2006
#msg-28527550 Exercise prices of executive options
#msg-27656417 Largest shareholders


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-27253453 Musings on the ATryn price
#msg-24709713 Official UK product specs
#msg-20873099 Sales projection for HD indication in EU
#msg-8316050 Leo Pharma partnership announcement
#msg-26883688 What is hereditary AT deficiency? (chase link at bottom)
#msg-9502819 A patient’s story
#msg-26144771 Official EMEA Documents on ATryn in HD


ATryn hereditary-deficiency program in U.S.
#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-27081539 Last patient enrolled in active arm
#msg-29145593 Likelihood of an FDA advisory panel
#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-23864419 Risks/supply constraints of plasma-derived drugs
#msg-25340632 Dec07 iHub surveys on US partnership
#msg-27253453 Musings on the ATryn price
#msg-24751863 Sales projections for HD indication


ATryn DIC/sepsis program
DIC summary from GTC’s website
#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 Leo’s 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-25325852 Rough DIC timeline
#msg-14495208 When will GTC receive milestone payments?


Other potential indications for ATryn
#msg-29794528 CABG (musings by ‘rustyboy’)
#msg-29022959 Venn diagram of potential acquired-deficiency indications


Miscellaneous info on antithrombin and coagulation disorders
#msg-30170938 Reference list of antithrombin papers
Wikipedia entry on antithrombin
Highly technical paper on hereditary AT deficiency


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-27139814 Pharmacoeconomic rationale for FVIIa program
#msg-28922135 FVIIa has blockbuster sales already…
#msg-29656551 …and even larger sales are expected
#msg-14084250 FDA approves NovoSeven in acquired hemophilia
#msg-13763244 Patient pool for initial indication
#msg-30170941 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
#msg-26883499 GTC’s drug portfolio
Capsule summaries of internal programs
#msg-25039843 ProGenetics collaboration
#msg-25875091 LFB joins Factor IX program
#msg-29922768 Merrimack’s MM-093
#msg-29261415 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 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-27011864 Prolastin AAT from Talecris
#msg-27079832 Kamada injected and inhaled AAT programs
#msg-28121695 Kamada injected AAT hits primary endpoint
http://alpha1health.com Aralast AAT from Baxter
#msg-6488263 AAT from Purely Proteins (market-size info)

Non-transgenic recombinant products:
#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-29714514 FVIIa analogs from Novo Nordisk
#msg-29930840 Maxygen’s Maxy-Seven FVIIa analog
#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 Second-generation CD20 program from DNA/BIIB
#msg-24683024 HuMax-CD20 from GSK/Genmab
#msg-28770646 CD20 program from InNexus Biotechnology
#msg-25325807 Overview of CD20 programs (20-min video)
#msg-29944574 BioWa / Kyowa Hakko
#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-26569811 Biolex (CD20 program)
#msg-15925882 SemBioSys
#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-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)



Let’s talk biotech!
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”