Replies to post #45402 on Biotech Values

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Clinical / Regulatory / Litigation Calendar

[Please keep entries up to date! See updating procedure at the end of this post.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: CRME, DND, DDS, TH, CYT,

ACHN – See GILD

ADLR – Approvable letter for Entereg issued 11/6/06 requesting safety data due in 2Q07.

AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results: 2H07.

ANDS – ANA975 for HCV placed on hold 6/26/06 due to preclinical safety issue; human trials expected to resume at end of 2007 following FDA analysis of animal tox study.

ANDS – ANA380 in HBV: phase-2b to begin “sometime in 2007” (don’t hold your breath).

ANOR / AOM.TO – pivotal AMD3100 results any day.

ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.

BMY – Plavix litigation: trial began 1/22/07.

CEPH – Nuvigil approvable letter with minor issues received 3/30/07; response pending.

CLSC - Two phase 3 Trials 1600-2000 patients to complete in calendar Q4 with public " top line data" on results anticipated for calendar Q1 07. This is a 10 week trial.

COLY – Phase-3 PF-3512676 in NSCLC (by PFE): 2008? (2 trials).

COR – CX-717 tox data submitted to FDA 4/18/07 requesting removal of partial clinical hold; reply expected May, June, or July.

CRME - IV RSD1235 NDA refiled, PDUFA Oct 19, 2007.

CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.

CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).

DDSS (formerly LBPFF) – Tramadol PDUFA June 19, 2007.

DNA – Avastin in breast cancer: FDA requested additional data confirmation on 9/11/06; resubmission by DNA pending.

DND.TO - CIP Isotretinoin PDUFA April 27, 2007. Tramadol PDUFA May 3, 3007.

DNDN – Provenge BLA PDUFA date: 5/15/07.

FRX - Milnacipran in fibromyalgia: see CYPB.

GILD – Viread for HBV: phase-3 results 3Q07, NDA (if successful) 4Q07.

GILD – GS9190 polymerase inhibitor for HCV: data from phase-1: 3Q07.

GPCB – Satraplatin SPARC trial: final overall survival: fall 2007. (The trial hit the primary PFS endpoint on 9/24/06; interim OS look announced on 6/8/06 failed to meet threshold for unblinding.) NDA submitted 2/16/07.

GTCB – ATryn EU launch for HD: July 2007.

GTCB – ATryn DIC program in EU: start of ph-2 (by Leo Pharma) any day.

GTCB – ATryn ph-3 for HD in U.S.: complete enrollment 1H07, report data 2H07, submit BLA end 2007.

GTCB – Merrimack MM-093 phase-2 data in RA/psoriasis to be presented at EULAR in June 2007. Results of phase-2 extenstion trial in RA: late 2007.

GTOP – Final MyVax results Dec 07.

IDIX – Sebivo in EU: endorsed by CHMP 2/23/07; approval expected April-May. (Approved in U.S. 10/06 and in China 3/07.)

IDIX – NM283+ribavirin drug-interaction study: top-line data by PR late June 2007; full data at medical conference in fall 2007 (probably AASLD).

IDIX – Tyzeka phase-3 in decompensated liver disease: enrollment complete in 1Q07 (75% complete as of 9/27/06).

IMCL –
1) CRYSTAL trial in first-line CRC hit its PFS endpoint (announced 1/10/07); full data release at ASCO in June, 2007.
2) Erbitux in NSCLC. OS in 1st-line FLEX study: 2H07.
3) Erbitux in pancreatic cancer, SWOG trial. Missed Primary Goal. Full Data release at Asco 2007.
4) Erbitux with Chemo in H/N. Extreme trial. Primary Goal (OS) met. Full Data at Asco 2007.
5) Critical Trials in 1st line mCRC upcoming OPUS (cet/Folfox) and CAIRO2 (capox/bev/cet) top line results 2H07

ITMN – Phase-1 PK data for ITMN-191: 2H07.

JNJ: CoStar (CONR) data from U.S. pivotal trial: March 2007 at ACC

LBPFF – see DDSS

MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients.
Expect full enrollment Nov/07 with Data by August /08.
This drug has zero side effects, zero competition, and No Partnership yet with Big Pharma as of 3/31/07.

Merrimack: see GTCB

MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2007, trial results in 2008.

Novocell – see SRDX

NRMX, NRM.TO – North American Alzhemed trial complete Jan 07, results to follow. European Alzhemed trial complete 1H08 (?). Kiacta (Fibrillex) received an approvable letter on 8/11/06.

NVS – Tifacogin: enrollment complete 1H07 (#msg-15157973).

PHRM – See GPCB.

PPHM - Bavituximab 1B, adv. metastatic breast, lung or ovarian that failed prior chemo. 3/22/07 enrollment closed. top line data ~ May 07.

PPHM - Bavituximab 1B HCV 14 day monotherapy in non-responders/relapsers. 2/14/07 top-line info released. details at an upcoming conf.

RPRX
Proellex
*Uterine Fibroids Phase 2 (U.S.) Full Phase 2 data (mid-2007)
*One year extension data (4Q2007)
*Initiate pivotal trials (YE2007)
*Endometriosis Phase 1/2 (Europe) Full Phase 1/2 data (3Q2007)
*Initiate U.S. Phase 2 (mid-2007)

Androxal
*Male Secondary Hypogonadism Non-pivotal Phase 3 (U.S.) Full non-pivotal Phase 3 data (3Q2007)
*Initiate first pivotal Phase 3 (around YE2007)

SGP – Ph-2 data for SCH 503034 in HCV: 2H07

SNY – Acomplia advisory panel: 6/13/07; PDUFA date: 7/26/07.

SNY – Plavix litigation: trial began 1/22/07.

SPPI – See GPCB.

SRDX - Novocell phase-1/2 trial in type-1 diabetes: late summer 2007 (enrollment complete 8/30/06).

TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.

VRTX – PROVE-1/PROVE-2/PROVE-3 timetable: see #msg-12267294

YMI – AeroLEF ph-2b final results: ? (interim results announced on 9/27/06 failed to meet threshold).

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Procedure For Updating Clinical-Trials List

When adding or modifying entries, please follow these steps:

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