Biotech Values

[DewDiligence]

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: DNDN IDIX.


ACHN – See GILD

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

AGIX – ARISE data at ACC March 24-27, 2007.

AMGN – Vectibix PACCE trial in 1st-line CRC (Avastin+FOLFOX+/-Vectibix) interim PFS based on 25% of events: 2Q07 (probably ASCO). (PACCE showed no benefit vs control in RR.) Vectibix final OS from ‘408’ study: any day (low chance of hitting endpoint).

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 2H07 following FDA analysis of animal tox study.

ANDS – ANA380 in HBV: phase-2b to begin “sometime in 2007.”

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.

BMY – Erbitux: see IMCL.

BOMSF -reporting pivotal MBP8298 results 2 years roughly

CEPH – Nuvigil for EDS approvable letter received 4/30/06; on 12/7/06, FDA said it was still studying one case of suspected SJS in Sparlon data set.

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): late 2007 or 2008 (2 trials).

COR – CX-717 tox report to be submitted to FDA in March. (FDA clinical hold was partially lifted 10/9/06.)

CORT – Phase-3 trials of Corlux for psychotic major depression: ‘06’ trial results any day. (The first phase-3 trial called ’07’ reported failed results on 8/25/06; the 2nd phase-3 trial called ‘09’ reported failed results 9/29/06).

CRME - IV RSD1235 NDA refiled, FDA decision likely 4th qtr/07.

CVTX - Ranexa MERLIN data at ACC March 24-27, 2007.

CYT.TO - Initiated pivotal A-fib trial Oct/06. Results timing, will update when company provides timeline.

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

DDSS (formerly LBPFF) – Response to and appeal of Tramadol approvable letter submitted 12/20/06.

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

DNDN – Provenge BLA: advisory panel 3/29/07; PDUFA date 5/15/07.

DNDN – 9902b study: enrollment complete in 2007; interim data look 1H08.

FRX - Milnacipran in fibromyalgia: see CYPB.

GILD – Viread for HBV: phase-3 results 4Q07, NDA (if successful) 1H08.

GILD – GS9190 for HCV: start phase-1 any day.

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: June, 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, submit BLA 2H07.

GTCB – Merrimack MM-093 phase-2b in RA, phase-2 in psoriasis to be presented at EULAR in June 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 – (See #msg-9218093 for selected Erbitux trials):
1) CRSYTAL 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: 1Q07.

ISA.TO - Begin European/Cdn pivotal psoriasis trials this qtr, begin U.S. pivotal psoriasis 07, complete enrollment in renal Phase IIb & also interim renal data 1st qtr 07.

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

Merrimack: see GTCB

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

NRPH – NRP104 in pediatric ADHD: approvable letter 10/6/06; full approval pending DEA scheduling.

NVS – Tekturna PDUFA date mid Mar 2007.

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

PHRM – See GPCB.

PPHM - Bavituximab phase 1B HCV; four doses monotherapy over 14 days, followed for 12 weeks post-therapy, in previous non-responders/relapsers. Patient enrollment completed Oct 24, trial results due 1Q 07.

PPHM - solid tumor 8-week chemo & Bavituximab combination therapy, info due 1Q '07.

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 PDUFA date: 4/26/07.

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

Speedel – See NVS.

SPPI – See GPCB.

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

TH.TO -Begin confirmatory TH9507 HIV Associated Lipodystropy trial 1st qtr/07

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

YMI – AeroLEF final results any day (interim results announced on 9/27/06 failed to meet threshold).

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