Biotech Values

[Aiming4]

Clinical-trial / regulatory calendar:

[Please see updating procedure at the end of this post.]


Edits: Updated Cortex COR dates per 9-8-05 Roth Conference presentation (thanks Gfp)

Another link to follow for some of same info:
http://www.biotechwatch.com/eagle/milestones.html


ABGX- international Panitumumab phase-3 results in refractory mCRC: late 3Q05 or early 4Q05.

AGEN - Ph iii in RCC 2H05

AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.

ALKS – 9/30/05 PDUFA date for Vivitrex NDA.

AORMF -pivotal AMD3100 results 2nd half 06.

AVN – Neurodex for PBA filing-acceptability date: 10/10/05.

AXCA -pivotal Itax results 1st half 06.

BMY – 12/31/05 revised action date for Orencia (CTLA-4).

BOMSF -reporting pivotal MBP8298 results 2 years roughly

CEPH – Attenace (Provigil) PDUFA date in ADHD: 9/05; Nuvigil PDUFA date in EDS: 1/06; Oravescent Fentanyl PDUFA date: 7/6/06.

COR - Oct 2005: Interim analysis - IIa Alzheimer's CX-717 Ampakine trial.
COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: Results of IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA).

CORT - 1H 06 - Results of Ph ii of RU-486 on reversal of Alzheimers functionality
CORT - 1H 06 - Results of Ph iii of RU-486 on Psychotic MD

CRME - RSD1235 phase III data in mid September.

CNVX - Last interim look at melanoma vaccine in Q3/Q4 05

CYAHF -20 patient IDE results 4th qtr, then begin the pivotal phase 1st half 06 as well as commercial launch in Europe later this year.

CYPB – 3Q05 first Phase-3 of Milnacipran in fibromyalgia (in data analysis now); 3Q06 second (mirror) phase-3 study (either 3-mo or 6-mo of follow-up)

DNA - Rituxan ph III results in RA in Q3 05
DNA - Lucentis phase-3 ANCHOR in 4Q05.

DNDN - 1H 06 ttp data for 9902B Provenge Phase III
DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC

FRX - Milnacipran in fibromyalgia: see CYPB entry

GENR – Phase-2 AMD data from “208” trial at AAO: 10/05; start of second phase-3 AMD trial: 2H05.

GPCB – Satraplatin SPARC trial: interim efficacy 1Q06, final efficacy 2Q06. (Endpoint is a complex TTP metric.)

GTCB – EMEA opinion on ATryn: Oct 2005

IDBE -begin pivotal Fluinsure trials this winter.

IMCL – Erbitux H&N PDUFA date: late Feb 06 (sBLA submitted 8/30/05).

INSM - pdufa date for somatokine 10/03/05

ISTKF -report interim Phase III ISA247 psoriasis results August and unblinded results in October.

LBPFF -report Tramadol Phase III U.S. results 2nd half as well as European launch 4th qtr.

LRP -report pivotal viruzulin results later this year (2005).

MYOG - Top-line data from Ambrisentan phase-3 trials in PAH: ARIES-2 in 4Q05, ARIES-1 in 2Q06.

NABI - ph iii results for vaccine against staph in Q3/Q4 05

NKTR – Exubera endorsed by advisory panel 9/8/05 by 7-2 vote, awaiting FDA action.

NVS – LAF237 pivotal data in diabetes: early 2006.

ORPH (to become JAZZ?)--2H 05-data from the clinical trial designed to evaluate Xyrem in the treatment of fibromyalgia syndrome

PDLI - Q2 06 volociximab ph II for solid tumors

PTIE - All are 2H05
Oxytrex(TM) Osteoarthritic Pain - Phase III Report top-line results
PTI-901 Irritable Bowel Syndrome - P.III Report top-line results in women

PTN- Q2 2006 ph.IIb results for PTN-141 in male erectile dysfunction

RNAI – Sirna-007 final phase-1 AMD data at AAO: 10/05.

SPPI – See GPCB.

TELK - Telcyta 3rd line NSCLC and 3rd line Ovarian results 1H06

TH.TO -report ThGrf Phase III Hiv-associated lipodystrophy results late 06.

VSGN - Celacade phase-3 in chronic HF (ACCLAIM) fiscal 1Q06 (Dec 05-Feb 06).

YMI - early 2006?--The pivotal Phase III trial was initiated in March 2004, enrolling 700 patients at 86 sites across 13 countries. The outcome of the trial will be reviewed in light of the Special Protocol Assessment received by YM from the FDA. Because of a subsequent agreement with the FDA to apply a Sequential Analysis to the trial that permits stopping the trial following 192 "events" provided certain criteria are met, YM anticipates that the trial might be completed as early as mid-2006.
YMI - report pivotal Tesmilifine breast cancer results possibly 2nd qtr 06.
YMI – AeroLEF phase-2b data report: 2Q06.


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