Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar:

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


Edits: Lucentis BLA submitted; FDA decision on Priority Review expected Feb 2006.


ABGX - PACCE trial (chemo+Avastin+/-Pani) in 1st-line CRC: first interim RR 4Q05; Pani “408” trial in 3rd-line CRC (the trial that just caused all the commotion) final survival: 2Q06.

AGEN – Top line results for Phase III of Oncophage treating RCC Mar'06.

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

ALKS – Vivitrol approvable letter issued 12/28/05—approval expected 2Q06.

AMGN – See ABGX

AORMF -pivotal AMD3100 results 2nd half 06.

AVN – FDA acceptance for filing of NDA for PBA: delayed (was 10/10/05).

AXCA -pivotal Itax results 1st half 06.

AZN--see RNVS

BIIB – Tysabri (resubmission) PDUFA date 3/25/06

BOMSF -reporting pivotal MBP8298 results 2 years roughly

CEPH – Sparlon (Provigil for ADHD in kids): approvable letter issued, approval pending; Nuvigil for EDS PDUFA date 1/06; Oravescent Fentanyl PDUFA date: 7/6/06. Vivitrol: see ALKS.

CONR – CE Mark (EU approval) of CoStar stent: late 2005/early 2006. Final pleadings in U.K. patent litigation: mid-Dec 2005.

COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: PET scan results - IIa Alzheimer's 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 iii of RU-486 on Psychotic MD

CRME - Phase III RSD1235 ACT 2 CABG data in Q4/05 or Q1/06

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 – Phase-3 Milnacipran in fibromyalgia, second phase-3 study (either 3-mo or 6-mo of follow-up) 3Q06 (maybe —Dew).

DNA - Lucentis: FDA decision on Priority Review expected Feb 2006 (BLA was submitted 12/30/05)
DNA - Avastin 1st line mNSCLC sBLA filing 1Q 06
DNA - Avastin 1st line MBC sBLA filing 1Q 06
DNA - Herceptin adjuvant breast cancer sBLA filing 1Q 06
DNA - Rituxan in RA PDUFA 2/28/06
DNA - Rituxan in FL Agg NHL PDUFA 2/22/06

DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC

DSCO - 2ndQ 06 - Approval for IRDS and market rollout

ELN – See BIIB

FRX - Milnacipran in fibromyalgia: see CYPB.

GENR – Interim data in phase-2 “209” study: spring 2006 (?).

GPCB – Satraplatin SPARC trial: interim PFS 1Q06/2Q06, final PFS 2H06, final overall survival 2H07.

GTCB – EMEA opinion on ATryn: Feb. 2006; Merrimack phase-2b MM-093 in RA: mid 2006.

IDBE -begin pivotal Fluinsure trials this winter.

IMCL – Erbitux PFS in (Merck KGaA) CRSYTAL trial in first-line CRC: 2H06; Erbitux H&N PDUFA date: end of Feb 06 (sBLA submitted 8/30/05).

LBPFF – PDUFA date for Tramadol NDA: 9/28/06.

Merrimack: see GTCB

MYOG - Ambrisentan phase-3 trials in PAH: ARIES-1 in 2Q06; (ARIES-2 was reported on 12/12/05).

NKTR – Exubera: endorsed by advisory panel 9/8/05 by 7-2 vote; FDA action by late 1/06.

NVS – LAF237 pivotal data in diabetes: early 2006.

PDLI - Q2 06 volociximab ph II for solid tumors

PHRM – See GPCB.

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

RHEO – Pivotal trial in dry AMD: data being cleaned – expected report 1Q06.

RNVS-CHANT Phase IIb safety trial during the first quarter of 2006; AZN to file regulatory applications for Cerovive (NXY-059) during the first half of 2007.

SCLN - Second HCV ph-3 trial data May 06; (first HCV reported 12/14/05).

SPPI – See GPCB.

SRDX - Phase-1 DME data for I-vation w Triamcinilone: mid 2006; Novocell start of phase-1/2 trial in type-1 diabetes: imminent.

TELK – ASSIST-1 -2 and -3 phase-3 results: 1H06 (all 3 to be announced simultaneously).

Therion (private) – PanVac phase-3 survival results in second-line pancreatic cancer: 1Q06; ProstVac phase-2 (TTP) results of 120-patient trial in asymptomatic HRPC: 1Q06; start of ProstVac phase-3, 600-patient NCI trial in HDPC: 1H06.

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

VSGN - Celacade phase-3 in chronic HF (ACCLAIM): triggering events reached 11/14/05; data now in cleanup and analysis.

XNPT
1H2006
1) Initiate Phase 3 study in RLS for XP13512
2) Phase 2a results in GERD for XP19986
3) Partnership for either XP13512 or XP19986

YMI - Tesmilifene met breast cancer pivotal study fully enrolled. The first of three planned interim analyses of data from this trial will occur in mid calendar 2006 with the others expected during the balance of the year." Via SPA, approval as early as 2007.
YMI – AeroLEF phase-2b data report: 2Q06.

--
Procedure For Updating Clinical-Trials List

When adding or modifying entries, please follow these steps:

1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.

2. Make your additions or modifications, inserting any new items in alphabetical order.

3. Post the updated text in a new message in reply to the message with the old list.