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: ADLR (deleted entry for Entereg advisory panel—news already out); VRTX (news of FDA meeting on Telaprevir already out).


ACHN – See GILD

AMGN – Denosumab: Three-year data from phase III PMO trials (vs. alendronate) 1Q08; three-year data from phase III PMO fracture study: 2H08; Presentation of data from phase III HALT trial in breast cancer: 1H08; Data from phase III HALT trial in prostate cancer: 2H08.

AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.

CEGE - VITAL1 GVAX prostate phase III interim "1H/'early' 2008. Final analysis ?09
- GVAX + MDX010 P1 results ?08
- oncolytic virus (bladder cancer) P1 results at AUA(5/08)

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

DDSS – Tramadol NDA: second approvable letter received 5/31/07. New clinical trial likely. Ph III Trazodone results 2nd qtr/08

DNA – Avastin sBLA in breast cancer PDUFA date: 2/23/08 (advisory panel voted 5-4 against on 12/5/07); Avastin adjuvant CRC interim look Q2 08; Rituxan in Primary Progressive MS Ph III Results Q2 08.

DNDN – Provenge 9902b study: interim analysis (~180 deaths) 2H08; final analysis (360 deaths) 2010.

ELN – AAB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.)

ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)

GILD – Viread in HBV: FDA PDUFA date 8/11/08; EMEA action date expected 2Q08. (NDA and MAA submitted 10/11/07.)

GILD – GS9190 polymerase inhibitor for HCV: new phase-1 trial to test QT-prolongation announced 10/18/2007; no start date yet.

GTCB – ATryn phase-3 for HD in US: report top-line data late Jan 2008, submit BLA mid 2008.

GTCB – US Atryn partnership announcement: 1Q08 (presumably after top-line data report).

GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete end 2008.

GTCB – Merrimack MM-093 results of phase-2 extension trial in RA: July 2008.

HGSI – Phase-3 Albuferon: report data from genotype-2/3 phase-3 trial: end 2008; report data from genotype-1 phase-3 trial: spring 2009; submit BLA fall 2009.

IDIX – IDX899 for HIV: report final results from 7-day phase-1b monotherapy and interim results from phase-2a monotherapy study at CROI in Feb 2008; start 6-week phase-2 head-to-head vs Sustiva: 1H08.

IDIX – IDX184 nucleotide polymerase inhibitor for HCV: file IND 1H08.

IDIX – Protease inhibitor for HCV: file IND in 2008.

IDIX – Tyzeka vs Baraclude phase-4 (12 weeks PK): report data late (?)

ISA.TO-European psoriasis P3 results 2008. Phase 2B 6&12 month renal results 2008. Phase II/III Uveitis results 2008.

ITMN – ITMN-191 Phase-1b: enrollment of 3rd dosing cohort complete by end of Jan 2008. (Data from first two cohorts reported 1/7/08.)

ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results Late 2008 (72 week treatment period). No interim analysis planned, though monitored for safety.

JNJ – TMC125 for HIV: FDA action date 1/18/08.

LBPFF – see DDSS

MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients, one of the largest trials in Canadian History.
Full enrollment completed Sept. 14 with Top Line Data expected by Late February /08 or Mid March at the latest.
No Partner as of yet and Tons of Cash in the Bank.

MEDX - Ipilimumab BLA submission sometime in 2008 (phase-3 data reported 12/10/07).

Merrimack: see GTCB

MNTA – Meeting with FDA re Lovenox ANDA: date not specified, but soon.

MNTA — Lovenox patent appeal (Sanofi v Amphastar): arguments begin 1/8/08.

MNTA – M118 phase-2 data in stable angina to be presented at unspecified medical conference in 2008.

MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.

NBIX - NBI-56418 Complete enrollment, 6-month phase 2b endometriosis trial 4Q07
NBIX - NBI-56418 Topline data, 6-month phase 2b endometriosis trial 2Q08

Novocell – see SRDX

NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).

Pharming – Rhucin for HAE FDA BLA submission by year-end 2007 (?) (MAA was rejected by EMEA in Dec 2007.)

PHRM – Satraplatin MAA to EMEA to be filed 2/08 following analysis of final OS data.

PPHM -
Bavituximab (anti-viral): phase 1B HCV top-line info released 3/07. Final data presented at AALSD 11/07
Bavituximab (anti-viral): phase 1 trial in HCV/HIV coinfected patients initiated 7/07. Johns Hopkins added as additional site 12/07

Bavituximab (anti-cancer): phase 2 breast cancer trial protocol submitted to reg. board 9/07
Bavituximab (anti-cancer): phase 2 lung cancer trial protocol submitted to reg. board 7/07
Bavituximab (anti-cancer): (additional) phase 2 breast cancer trial initiated 11/07
Bavituximab (anti-cancer): Update/presentation on completed phase 1B, (top line info was released 5/07), and interim data on phase 1A to be presented
Feb8’08, at 10th Intl. Symposium on Anti-Angiogenic Agents.

PPHM –
Cotara: phase 2 glioblastoma multiforme Indian trial patient enrollment initiated 6/07.
Cotara: glioblastoma multiforme US trial sites expanded to include MUSC 6/07.

RPRX– Proellex
*Initiate US PII Endometriosis trial (Enrollment Oct 2007)
*One year extension data (Q1 2008)
*Initiate Fibroids Pivotal PIII trials (?)
*Initiate Anemia Pivotal PIII trial(s) (? – New IND required)

RPRX – Androxal
*Initiate Pivotal PIII trials (?)

RPRX – Other: select alternate Proellex-class compound for advancement into breast cancer studies via potential partner TBA.

SGP – Boceprevir ph-2 trial in treatment-naïve HCV: 12-week data reported on 10/18/07 (#msg-23788779); end-of-treatment data due in 2008 and SVR data in late 2008 or early 2009.

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

SYMD- Synthemed-Circulatory System Devices Advisory Panel has been scheduled for September 19, 2007 for Repel CV.

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

UTHR - Oral Treprostinil (FREEDOM-C). 16 week combination study.
UTHR - Oral Treprostinil (FREEDOM-M). 12 week monotherapy study.

VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.

VRUS – Initial R7128 phase-1b data were reported on 1/7/08.

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