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: ACHN GILD PIP RDEA


ACHN – ACH-1095 (a.k.a. GS-9525) HCV NS4A inhibitor: start phase-1 4Q08.

ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.

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

APPA---3Q08--reports results of its pivotal Phase 3 study in chemotherapy-induced nausea and vomiting (CINV) comparing the efficacy of APF530 (a proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of acute and delayed onset CINV in both moderate and highly emetogenic chemotherapy treatments.

BMY Apixaban – phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): data at ASH Dec08; phase-2 in ACS: data at European Society of Cardiology Sep08.

CEGE
- 2H08: GVAX pancreas, leukemia P2 data
- 1H09: GVAX prostate VITAL-2 P3 enrollment completion and interim analysis
- 2H09: GVAX prostate VITAL-1 P3 Final Analysis

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

DNDN – Provenge 9902b study: interim analysis October 2008; final analysis (304 deaths) 2H09.

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.)

GENZ – FDA panel on Myozyme sBLA (this is the version of Myozyme produced at a new manufacturing plant): Oct 2008.

GILD – GS-9525 HCV NS4A inhibitor: see ACHN.

GILD – GS-9190 HCV polymerase inhibitor: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.

GTCB – FDA action on ATryn BLA: early Feb09 (assuming priority review); BLA submitted 8/7/08.

GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: report data 2H09.

GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: Aug 2008; results of pilot study in uveitis: late 2008.

GTCB – Protexia: see PIP.

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 – See #msg-31357745

ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.

INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) .
INSM - Iplex in HARS on hold due to cash.
INSM - Iplex expanded acces program for ALS in italy , ALSFRS scale used to collect data, no targets or clinical endpoints set though.
INSM - NDGA phase II trial run by UCSF in prostate cancer started may 2008. Primary data may 2009.

ITMN – ITMN191 Final MAD monotherapy data at AASLD in Oct08 (data from first four cohorts announced at EASL 4/1/08). Data from 14-day triple- combination study: late 2008 (probably not in time for AASLD; trial started 5/29/08).

ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).

LEVP – See VPHM.

MAXY – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)

Merrimack – See GTCB.

MNT – PureTox botulinum toxin: report data from first phase-3 trial calendar 4Q08; submit BLA calendar 4Q10 (after completion of two other phase-3 trials).

MNTA – Appellate court ruling on Lovenox patent en banc rehearing: 8/21/08.

MNTA – Lovenox ANDA resubmission: 3Q08. (Prior FDA response received 4/28/08.)

MNTA – M118: report phase-2 data in stable angina: 1Q09/2Q09; ink partnership deal: 2Q09.

MNTA – Copaxone ANDA: possible FDA decision in 2009-2010 (ANDA accepted for review on 7/11/08).

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

NVAX - Phase 2 data for pandemic-flu vaccine... safety and immune response in 230 volunteers next month (august?)

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

OXGN - 4Q 08 File IND for Zybrestat topical in ophthalmology
OXGN - 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN - 2H 08 Partnership (listen to 2Q CC)

Pharming – Rhucin submission to FDA possibly in 2008; positive phase-3 data reported 6/16/08.

PIP – Protexia nerve-agent antidote: file IND Aug08; start phase-1 Sep08.

PPHM- Bavituximab (cancer): PII MBC Bavi/Docetaxel 1st stage successful. Trial moves to 2nd stage July 08
PPHM- Bavituximab (cancer): first patient dosed in PII NSC lung cancer trial w/carboplatin/paclitaxel June 08
PPHM- Bavituximab (cancer): approval received to conduct PII MBC trial w/carboplatin/paclitaxel Jan 08
PPHM- Bavituximab (cancer): phase I monotherapy trial, estimated completion Sept 08
PPHM- Bavituximab (viral): phase I trial: HCV / HIV coinfected patients: estimated completion Sept 08
PPHM- Cotara: phase II glioblastoma multiforme trial - next interim update 2H 08
PPHM- Cotara: glioblastoma multiforme US trial - data presented at ASCO 08, estimated completion Sept 08

RDEA – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08.
‘
RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008

SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR data for 48-week arms: late 2008 or early 2009. (SVR data for the 28-week arms and SVR12 data for the 48-week arms were reported on 8/4/08: #msg-31189981.)

SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).

VPHM – PDUFA date for Cinryze: 10/14/08.

VRTX – PROVE-3 trial in treatment-experienced HCV: SVR data 4Q08, presumably at AASLD. (EoT and some SVR12 data were reported on 6/9/08.)

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

ZGEN – IFN-Lambda in HCV: report interim ph1 monotherapy data at AASLD in Oct 2008.

ZGEN – IL21 w Nexavar in RCC: interim ph2 data at EORTC in Oct 2008.

ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.

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