Replies to post #3716 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Oops—I neglected to mention in the bracketed statement at the top of the ReadMeFirst that the update includes GTC’s greatly increased sales projection for ATryn in DIC. This is surely the most consequential addition or revision.

[DewDiligence]

GTCB ReadMeFirst

[Miscellaneous updates including a new discussion of GTC’s role in Follow-On Biologics.]


What is GTC’s business all about?
#msg-19391437 What is the business model?
#msg-20969073 GTC’s role in Follow-On Biologics
#msg-20965937 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-19390137 Edited transcript from 1Q07 conference call (5/3/07)
#msg-17607391 Edited transcript from 4Q06 conference call (3/5/07)
#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-20766565 Cash balance and 2007 cash-usage guidance
#msg-15309465 Share count for valuation purposes
#msg-19928950 Projected ATryn sales >$1B
#msg-17760532 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi
#msg-19227430 What is a fair price?


Upcoming events
#msg-20965737 Clinical, preclinical goals in 2007-2008
#msg- 20965780 Possible/probable news flow


Management and BoD
#msg-15702541 Composition of Board of Directors
#msg-19222735 Largest shareholders as of 4/5/07
#msg-20149977 Current insider holdings
#msg-18919535 Insider buying during past year
#msg-18432652 Recent executive hires


ATryn hereditary-deficiency program in Europe
#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-20966468 Plasma-derived AT in U.S. is in short supply
#msg-19342893 U.S. ATryn timeline
#msg-5607789 Efficacy endpoint is clinical DVT
#msg-5609005 Design of control arm
#msg-11410659 Likelihood of success
#msg-6632420 Patient eligibility and exclusions
#msg-11511614 Musings on a U.S. partnership
#msg-20966607 Risks/supply constraints of plasma-derived drugs
#msg-7306242 Which antithrombin will doctors prescribe?


ATryn DIC/sepsis program
#msg-20150779 Scientific rationale (summary)
#msg-20150658 Scientific rationale (detailed)
#msg-16968800 How sepsis causes DIC
#msg-12483101 Existing therapeutic options are weak
#msg-12480578 Sepsis incidence is on the rise
#msg-16968788 Sepsis incidence is on the rise (addendum)
#msg-8316050 Leo Pharma partnership announcement
#msg-12430822 Economics of the Leo partnership
#msg-12511434 Phase-3 timeline
#msg-14495208 When will GTC receive milestone payments?
#msg-15305927 Design issues in the phase-2 trial


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


GTC-LFB program in Factor VIIa (and other therapies)
#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 always wanted to know about FVIIa in practice
#msg-16645259 NovoSeven reaches blockbuster status
#msg-16968837 FVIIa sales projections
#msg-13763244 Patient pool for initial indication
#msg-19404190 rFVIIa as a prophylactic treatment
#msg-14084250 NovoSeven for acquired hemophilia
#msg-13925693 NovoSeven for trauma
#msg-14921693 NovoSeven use in the military
#msg-20966607 Risks/supply constraints of plasma-derived drugs


Miscellaneous research and development programs
Capsule summaries: http://www.transgenics.com/products/prod.html
#msg-17933985 Pipeline timeline
#msg-20967220 Merrimack supply relationship
#msg-18566648 PharmAthene supply relationship
#msg-15170172 Background info on AAT deficiency
#msg-13797351 Grant for CD137 antibody program
#msg-7136629 Collaboration with Scancell
#msg-4316445 ATryn research contract with U.S. army


Intellectual property
#msg-9174865 Production (“milk”) patent
#msg-7179529 Purification patent
#msg-16887499 List of pending patent applications
#msg-20219243 Patent application re ADCC
#msg-20243324 Patent application re non-secreted proteins
#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-20966607 Risks/supply constraints of plasma-derived drugs
#msg-7306242 Which antithrombin will doctors prescribe?
#msg-11909951 Thrombate from Talecris
#msg-15898317 Plasma-derived AT from Grifols
#msg-11829819 Talecris AAT
#msg-6488263 PurelyProteins AAT (market-size info)
#msg-20093251 Inhaled AAT from Kamada

Non-transgenic recombinant products:
#msg-14524596 Artisan Pharma thrombomodulin
#msg-14527640 Comments on Artisan’s program
#msg-15157973 Tifacogin for CAP/sepsis
#msg-14176380 AM-Pharma program in sepsis
#msg-14499024 AZN/Protherics program in sepsis
#msg-15573025 Lipoxen/Baxter program in clotting factors
#msg-18366299 Novo-Nordisk NN1731
#msg-18366317 NN1731 (addendum)
#msg-20476514 GlycoPEGylated FVIIa from NVO
#msg-19911920 Maxygen Maxy-Seven
#msg-20047507 BioWa (enhanced ADCC)
#msg-17050443 DSM/Crucell antibody production
#msg-13600478 Protalix
#msg-20143313 Novozymes
http://greenovation.com Greenovation

Products derived from transgenic animals:
#msg-16835174 Technical issues with transgenic chickens
#msg-20655865 Viragen drops avian program
#msg-7542154 Origen (chickens)
#msg-15899425 Kirin/Hematech (cows)
#msg-18396260 Roche (polyclonal antibodies)

Products derived from transgenic plants:
#msg-18566945 Risks of plant-based platforms
#msg-15116312 Biolex (publication on homogeneity of glycosylation)
#msg-16610930 Biolex (Locteron)
#msg-19450622 Biolex collaboration with Genmab
#msg-5919466 Biolex (‘plantibody’ patent)
#msg-15925882 SemBioSys (plant-based insulin)
#msg-14191540 Prairie Plant Systems

Miscellaneous competition:
#msg-19221436 ATryn vs FXa inhibitors
#msg-13169472 GlycoFi/Merck (humanized yeast glycosylation)
#msg-13222976 More on the GlycoFi story
#msg-20702138 Penn State’s mushrooms
#msg-8863527 Companies to watch


Feature stories on GTCB and transgenics
#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)