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Re: ghmm post# 69967

Tuesday, 01/06/2009 4:35:00 PM

Tuesday, January 06, 2009 4:35:00 PM

Post# of 257262
Late-Stage Products Looking for a Home

Criteria for inclusion:
a) Program is in phase-3 or beyond and is non-partnered.
b) Company does not have enough cash to bring the product to market.

Edits: Added - CRGB, INFI, OREX, SVNT; Removed - LJPC
  

Stock Product Stage Comments
----- --------------- --------------------- -----------------------------
AEZS Cetrorelix Phase 3 BPH Q3 '09 Efficacy results due.
AUXL Xiaflex Phase 3 Dupuytren's Contracture (and PH2 for peyronie's and frozen shoulder syndrome)
BPAX Libigel Phase 3 ~2010 Submit Adequate Safety?
CHTP Droxidopa Pivotal Phase III Orthostatic hypotension. Results expected 02/09.
CRGB Abiraterone Phase 3 Prostate cancer
DYAX DX-88 for HAE BLA filed 9/24/08 (CABG indication partnered w CBST)
EPIX Vasovist PDUFA 12/30/08 FDA initially rejected saying 2 more studies needed. Looking to sell outright on approval.
GNVC TNFerade Pivotal Phase III Pancreatic cancer
INFI Retaspimycin Phase 3 GI stromal tumors
JAV Dyloject Phase III Approved in UK. Post operative Pain (injectable)
JAV Ketamine Phase III Acute moderate-to-severe pain (intranasal)
NTII Viprinex Phase 3 Interim analysis January '09. Stroke Drug, high chance of failure.
OREX Contrave Phase 3 Obesity
OXGN Zybrestat Phase 3 Anaplastic thyroid cancer
Pharming Rhucin Pre-BLA Rejected in EU
Protalix prGCD Phase III Gaucher's disease. Not enough cash for a commercial infrastructure
RPRX Proellex Phase 3 Uterine fibroids
SVNT Puricase BLA filed Treatment refratory gout




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