Replies to post #3057 on GTC Biotherapeutics (fka GTCB)

[Preciouslife1]

Thank you Dew. Will do my DD now.....much appreciated.

[DewDiligence]

GTCB ReadMeFirst

[Expanded discussion on the economics of
Merrimack and PharmAthene collaborations;
additional entries and improved organization
of section on competition; new material on
scientific rationale for DIC/sepsis program;
updated reference list on biogenerics.]


What is GTC’s business all about?
#msg-15159486 The business model in a single sentence
#msg-17607391 Edited transcript from 3/5/07 conference call
#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)
#msg-17598322 Reference info on biogeneric/biosimilar drugs
#msg-17935613 Venn diagram of business model
#msg-15638633 Musings on business model (Dew)


Valuation and finances
#msg-17702024 Cash balance and 2007 cash-usage guidance
#msg-15309465 Share count for valuation purposes
#msg-17591547 Press release for 4Q06 results
#msg-17760532 Valuation comparator: Pharming
#msg-11037571 Valuation comparator: GlycoFi


Upcoming events
#msg-16969103 Clinical, preclinical goals in 2007-2008
#msg-17980761 Possible/probable news flow


Management and BoD
#msg-15702541 Composition of Board of Directors
#msg-18458404 Current insider shareholdings
#msg-18432652 Recent hires


ATryn hereditary-deficiency program in Europe
#msg-11752181 Why ATryn?
#msg-11399356 ATryn approved by EMEA
#msg-8316050 Leo Pharma partnership announcement
#msg-12430822 Economics of the Leo partnership
#msg-14545343 HD sales projection
http://www.atiii.com What is hereditary AT deficiency? (simple)
http://tinyurl.com/yb9hl5 What is hereditary AT deficiency? (technical)
#msg-9502819 A patient’s story
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-18463014 U.S. ATryn timeline
#msg-6543884 Limited availability of competing antithrombin
#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


ATryn DIC/sepsis program in Europe
#msg-18568204 Rationale for pursuing DIC/sepsis indication
#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


Risks and availability of plasma-derived proteins
#msg-17114738 Salient quote from CEO of ZymoGenetics
#msg-7306242 Which antithrombin will doctors prescribe?
#msg-4372780 Risks of plasma-derived proteins
#msg-17684473 Risks of plasma-derived proteins (addendum)
#msg-15535360 Risks of plasma-derived proteins (Mad Cow)
#msg-16098448 Limited supply of plasma-derived proteins
#msg-16098453 Limited supply of plasma-derived proteins (addendum)


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 (hemophilia w/inhibitors)
#msg-14084250 NovoSeven for acquired hemophilia
#msg-13925693 NovoSeven for trauma
#msg-14921693 NovoSeven use in the military


Miscellaneous research and development programs
Capsule summaries: http://www.transgenics.com/products/prod.html
#msg-17933985 Pipeline timeline
#msg-18566864 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 Pending patent applications
#msg-13154218 Nuclear-transfer IP from Geron


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

Plasma-derived products:
#msg-7221666 Price and availability of commercial plasma-derived AT
#msg-11909951 Thrombate AT from Talecris
#msg-15898317 Plasma-derived AT from Grifols
#msg-11829819 Talecris AAT
#msg-6488263 PurelyProteins AAT (market-size info)
#msg-14954548 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-17050443 DSM/Crucell antibody production
#msg-13600478 Protalix
http://greenovation.com Greenovation

Products derived from transgenic animals:
#msg-18396260 Roche / Therapeutic Human Polyclonals
#msg-16835174 Technical issues with transgenic chickens
#msg-16219066 Viragen / Oxford BioMedica (chickens)
#msg-16512199 Viragen admits it has a lot of work to do
#msg-7542154 Origen (chickens)
#msg-15899425 Kirin/Hematech (cows)

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-5919466 Biolex (‘plantibody’ patent)
#msg-15925882 SemBioSys (plant-based insulin)
#msg-14191540 Prairie Plant Systems

Miscellaneous competition:
#msg-13169472 GlycoFi/Merck (humanized yeast glycosylation)
#msg-13222976 More on the GlycoFi story
#msg-8863527 Companies to watch
#msg-14687679 Lovenox is not a competitor of ATryn


Feature stories on GTCB and transgenics
#msg-17042733 Wired (2/14/07)
#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)