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: IDIX (data from CROI conference already out).


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.

BMY – Apixaban phase-3 in orthopedic surgery: fall 2008; phase-2 in ACS: Dec 2008 at ASH.

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 – AAAB001- final phase II data Q3 08
AB-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 in US: positive top-line phase-3 data were reported 2/4/08; BLA submission mid 2008; FDA action: late 2008/early 2009 assuming priority review.

GTCB – US Atryn partnership announcement: 1Q08.

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 phase-1/2 seven-day monotherapy study: additional, lower-dose cohorts to be reported during 1H08 (800mg cohort was reported 2/6/08).

IDIX – IDX899 phase-2 six-week head-to-head vs Sustiva (IDX899+Truvada vs Sustiva+Truvada): start enrollment 1H08.

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

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

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.

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.

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): oral arguments began 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 in EU: appeal of EMEA rejection to be submitted by 2/11/08;

Pharming – Rhucin in US: phase-3 top-line data 1Q08; BLA submission in 2008 if warranted by data.

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

PPHM -
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.

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: top-line data due in 2008 (enrollment complete 8/30/06).

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

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

--
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.