psycho-pharma schreef:
Speciaal voor France van Yahoo:
GTC products in develop, estimated sales, partners, + info*
*The following contains estimates - please do your own research... GTC IS A SPECULATIVE PLAY. Financing / CASH is needed beyond June 09 and major shareholder dilution is possible.
ATryn HD $75M
+ approved by EMEA / launched in Europe - Leo Pharma
+ GTC working to transition EU ATryn to LFB
+ fast track and orphan drug status by FDA
+ P3 US study met primary endpoint (Feb 08)
+ priority review granted by FDA
+ US partnership – OVATION Pharmaceuticals
+ possible partnership for Japan
ATryn DIC $1B+
+ P2 studies halted… possible transition to LFB
+ US partnership – OVATION Pharmaceuticals
ATryn CABG-HR $150M
+ prior clinical data exists
+ US partnership – OVATION Pharmaceuticals
ATryn milestone payments
EU - ($73M) - working to transition LEO to LFB
US - OVATION milestones ($257M)
LFB partnership - The overall structure of the collaboration is a 50/50 sharing of development costs and eventual profits from any products
Factor VIIa $1B+ - Recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade
+A lower price will encourage use in acquired hemophilia, trauma, and other acute-care settings.
+ clinical studies 2009 (LFB Biotechnologies)
Factor VIII
Factor IX
+ clinical studies 2009 (LFB Biotechnologies)
Alpha-1 antitrypsin $400M - Alpha-1 antitrypsin deficiency (Alpha-1) is a hereditary genetic disorder which may lead to the development of lung and/or liver disease. Worldwide, approximately 1 in 2,500 individuals has Alpha-1 Antitrypsin Deficiency. Alpha -1 is under-diagnosed; no cure @ present.
+ clinical studies 2009 (LFB Biotechnologies)
CD20 antibody - $4B - For oncology / auto-immune indications (Rituxan FoB)
(LFB Biotechnologies)
+ enhanced antibody-dependent cellular cytotoxicity (ADCC)
4 mAbs FoBs –likely Herceptin, Remicade, Enbrel, Erbitux - $16B (LFB)
*The following contains estimates - please do your own research... GTC IS A SPECULATIVE PLAY. Financing / CASH is needed beyond June 09 and major shareholder dilution is possible.
+ FoB’s are an avenue for GTC to leverage its proprietary production platform.
+ ADCC
+ discussions with potential partners
CD137 antibody $? - Immune modulation
+ glycosylated and non-glycosylated versions
"The CD137 antibody appears to have significant potential for the treatment of solid tumors and autoimmune diseases," stated Harry Meade, Ph.D., GTC's Senior Vice President of Research and Chief Scientific Officer. "
External products uniquely enabled by the expression capabilities of the transgenic platform.
Protexia (w/ PharmAthene) - Protexia is being developed as a pre- and post-exposure therapy for casualties on the battlefield or civilian victims of nerve agent attacks.
+ PharmAthene awarded a multi-year contract valued at up to $219M from DoD for advanced development of Protexia
+ a recombinant version of human butyrylcholinesterase (BChE)
+ human clinical study of Protexia in 4th quarter 2008
+possible use for Alzheimer
+ estimate mid-single-digit royalty to GTC on the sales
MM-093 (w/ Merrimack Pharma) MM-093 is a recombinant version of human alpha-fetoprotein (hAFP), an immunomodulatory serum protein
+possible use in multiple sclerosis
+ estimate high-single-digit royalty to GTC on sales
GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems.[/i]
Generic pharmaceuticals market
+early stage discussions with potential partners
Psycho