Biotech Values

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Clinical / Regulatory / Litigation Calendar

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Edits: ITMN/Roche (ITMN-191 testing w ritonavir underway); NVS (FREEDOMS data released).


ABT – Certriad PFDUFA date early Apr 2010 (NDA submitted 6/5/09).

Actelion – BUILD-3 phase-3 trial of Tracleer in IPF: PFS primary endpoint due Dec 2009.

AZN – Certriad: see ABT.

ACHN – ACH-1095 HCV NS4A antagonist: ACHN officially amended its agreement with GILD pertaining to ACH-1095 on 9/2/09 (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41217537 ) (GILD previously decided not to advance the compound due to pre-clinical tox issues seen at high doses); ACHN will advance the compound into the clinic at its own expense but may be reimbursed for such expenses if GILD elects to opt back in to development upon proof-of-concept.
ACHN – ACH-1625 HCV protease inhibitor: announced on 6/29/09 that dosing had begun in its Phase I European trial; ACHN expects to start US phase-1 trial 3Q09. (The split phase-1 trials are a new development; prior guidance for start of phase-1 was 1Q09.)

AGN – Botox for migraine: sBLA submission late 3Q09.
AGN – Botox for spasticity: CR letter received 5/25/09; reply by AGN in 60-90 days.

AMGN – Denosumab PDUFA date 10/19/09.

AMLN – Exenatide LAR: PDUFA date early Mar 2010 (NDA submitted 5/5/09 and accepted for review 7/7/09).
AMLN – Byetta monotherapy NDA: AMLN/LLY reported on 12/8/08 that FDA action will slip to an unspecified date in 2009.

ANDS – ANA598 phase-2 trial: safety and RVR data from 200mg arm: end 2009; safety and RVR data from 400mg arm: 1H10; SVR data: 2H10.

Bayer – Xarelto: see JNJ.
Bayer – VEGF Trap-Eye: see REGN.

DNDN – Resubmit Provenge BLA: 4Q09.

DORB - Orbec P3 confirmatory study in treatment of GVHD: expects to begin in 2H 09.
DORB - Orbec P2 in prevention of GVHD ongoing.

DYAX – DX-88 for HAE: response to FDA’s CRL submitted 6/8/09.

ELN – AAB-001 phase-3: final data mid-2011 (est.). (First patient dosed 12/21/07.)
ELN – ELND005 for AD phase-2: final data 1H10 (est.) (First patient dosed 12/21/07.)

FOLD - Plicera P2 in Gaucher: results expected in 3Q09.

GILD – GS9190 HCV polymerase inhibitor: fully enrolled; report data by end 2008.
GILD – Elvitegravir phase-3 vs Isentress: 50% enrolled; complete enrollment 4Q09.
GILD – ‘Quadro’ phase-2: complete enrollment (75 pnts) in May 2008; primary endpoint (24 weeks) by end 2008.
GILD – GS9450 (caspase inhibitor to inhibit fibrosis): start phase-2b 2Q09; report phase-2a data at AASLD (the HCV study, not the NASH study)

HEPH - Triolex for ulcerative colitis PII data Q2
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41057878

HGSI – Submit Albuferon BLA/MAA fall 2009. (Data from 2nd phase-3 trial reported 3/9/09.)

IDIX – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41527267 .

ITMN – ITMN-191: see Roche.
ITMN – pirfenidone: NDA submission 4Q09 (delay from 3Q09); MAA submission 1Q10 (delay from 4Q09).
ITMN – ITMN-520 qD pirfenidone analog for IPF and other conditions: IND filing mid 2010.
ITMN – See Actelion entry re BUILD-3 trial in IPF.

JNJ – Xarelto: reply to FDA’s CRL 4Q09.
JNJ – PurTox: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)
JNJ – Telaprevir: see VRTX.

MDVN – dimebon phase-3: final data Jan 2010.

MNTA – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41848714 .

MRK – Isentress sNDA for qD dosing: submission 2011. (Phase-3 trial called QDMRK started 4Q08: Isentress BID + Truvada vs Isentress qD + Truvada in first-line setting.)

NVS – FTY720 in RRMS: NDA and EU MAA to be submitted in late 2009. (Positive data from the FREEDOMS trial were reported on 9/30/09. The FREEDOMS trial plus the TRANFORMS trial and a portion of the FREEDOMS-II trial will comprise the NDA/MAA package.)
NVS – Albuferon: see HGSI.

ONTY – Phase-3 trial in Stage III NSCLC: first interim analysis (at 50% of deaths relative to trigger for final analysis): 2H10.

OXGN 2H 09 Initiate OXI4503 Phase 1 in AML
OXGN 2H 09 Interim Zybrestat NSCLC Phase 2 data
OXGN 2H 09 OXI4503 Phase 1 data (solid tumors)

REGN - Rilonacept in flare prevention upon initiation of allopurinol - results expected in 2010
REGN - Rilonacept in flare treatment - results expected in 2010
REGN - Aflibercept in 3 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred)
REGN - VEGF Trap-Eye: results from ph-3 trials in AMD 4Q10.

Roche – INFORM-1 trial in HCV: final data on all 7 cohorts to be presented at AASLD on 11/3/09 (interim data was presented at 2008 EASL).
Roche – ITMN-191 (a/k/a/ RG7127): phase-2b trial of SoC ± ITMN-191: RVR data from some arms 1Q10; report phase-1b data with ritonavir boosting early 2010.
Roche – RG7128 (f/k/a/ R7128): interim data on the first enrollment cohort in phase-2b trial: 4Q09. Note: this trial is being enrolled in two steps due to safety concerns.

SGP – Boceprevir NDA: 2011-2012 (based on SGP’s Nov 2008 R&D Day).

TSPT – Intermezzo PDUFA date 10/31/09.

VRTX – Telaprevir phase-3 ADVANCE and ILLUMINATE trials in 1st-line setting: SVR data 1H10.
VRTX – Telaprevir phase-3 REALIZE trial in 2nd-line setting: SVR data mid 2010.
VRTX – Telaprevir phase-2 ‘C208’ trial testing BID vs TID dosing: full presentation including SVR data 11/3/09 at AASLD.
VRTX – Telaprevir ± VX-222 (formerly called VCH-222): start phase-2 study 4Q09.
VRTX – Telaprevir: submit NDA 2H10.

VRUS – RG7128 (f/k/a/ R7128) and INFORM-1 all-oral HCV cocktail: see Roche.
VRUS – PSI-938 HCV purine-analog nuke: file IND 1Q10.

ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10

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Procedure for Updating Calendar

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1. Copy the complete text from the old calendar.

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