Biotech Values

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Clinical / Regulatory / Litigation Calendar

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Edits: ACHN (commences European Phase I for ACH-1625).


ACAD - Pimavanserin for dementia in Parkinson's patients due Dec 2009 per clinicaltrials.org

ACHN – ACH-1095 (a.k.a. GS9525) HCV NS4A antagonist: GILD has decided not to take ACH-1095 into the clinic due to concerns about the “therapeutic index” of the compound; ACHN is apparently trying to restructure its licensing agreement with GILD so that it can take the compound into the clinic on its own. The two companies are apparently still working on backup NS4A antagonists, notwithstanding what is now apparently two failed attempts to develop one.
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 headache: sBLA submission mid 2009.
AGN – Botox for spasticity: CR letter received 5/25/09; reply by AGN in 60-90 days.
AGN – Posurdex for DME: FDA decision late 2Q09.

AMGN – Denosumab: FDA panel 8/13/09; PDUFA date 10/19/09.

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

ANDS – ANA598 meeting with FDA Jul 2009 re proposed phase-2 design.

ARYX – ATI-5923 (“enhanced warfarin”) phase-2/3 data mid 2009.

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 - Amigal in SPA discussion: expecting phase 3 in Fabry to start 2Q 09. P2 extension data in 1Q 09.
FOLD - Plicera P2 in Gaucher: results expected in 3Q 09.

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)

HEB – Ampligen BLA: PDUFA date was 5/25/09 (originally 2/25/09), but FDA said it still needs more time.

HEPH - Triolex (HE3286) Phase II for type 2 diabetes: interim data shows no effect: http://biz.yahoo.com/e/090331/heph8-k.html
Triolex Phase I/II for ulcerative colitis, complete enrollment Q1 2009, Data Q2 2009
Triolex Phase I/II Rheumatoid arthritis, complete enrollment Q1 2009.

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

IDIX – See #msg-37320081.

INSM - NDGA phase II trial run by UCSF in prostate cancer started May 2008. Primary data: ? (was expected May 2009).
INSM - Iplex in ROP phase II: no date known yet

ITMN – ITMN191: see Roche.
ITMN – pirfenidone: NDA submission summer 2009; MAA submission late 2009.
ITMN – ITMN-520 qD pirfenidone analog for IPF and other conditions: IND filing mid 2010.

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.

LLY – Prasugrel: PDUFA date unknown. (FDA panel endorsed the drug on 2/3/09.)

MDVN – dimebon phase-3: final data Jan 2010

MRK – Isentress sNDA for first-line setting: PDUFA date Jul 2009.
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 FREEDOMS phase-3 trial: report data Jul 2009. (The FREEDOMS trial plus the TRANFORMS trial and the US subset from the FREEDOMS-2 trial will comprise the NDA package. TRANSFORMS, a 1-yr trial vs Avonex, hit its primary endpoint as reported on 12/12/08; FREEDOMS and FREEDOMS-2 have identical protocols with a 2-yr duration and a placebo control arm. Data from the US subset of FREEDOMS-2 will already be available and will be reported when FREEDOMS finishes.)
NVS – Albuferon: see HGSI.

OREX - Contrave ph iii - per clinicaltrials.org should have finished in April 09

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)

PIP – Phase-1 Protexia results 2Q09.

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 4 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VANILLA (1st line metastatic pancreatic + Gemcitibine), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred)
REGN - VEGF Trap Eye - 3 ph iii's expecting results from some by end of 2010.

Roche – INFORM-1 trial in HCV: full data at AASLD 11/09 (interim data was presented at EASL).
Roche – R7128: Report phase-2a EoT (28 days) data and start phase-2b trial: summer 2009.

RPRX – Proellex: ZPU-301 anemia/UF results end 2009 (had been 3Q09).
RPRX – Proellex: ZPU-302 anemia/UF results 1Q10.
RPRX – Proellex: ZPU-303chronic UF results end 2009.
RPRX – Proellex: ZPU-304 chronic UF results 1Q10.
RPRX – Proellex: NDA submission in both UF indications 2H10.
RPRX – Proellex: end of phase-2 mtng with FDA mid 2009; NDA 2H11.
RPRX – Androxal: P2b in fertility preservation results: 3Q09.
RPRX – Androxal: IND for type-2 diabetes 2H09.

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

TSPT – Intermezzo, a sublingual, use-as-needed insomnia treatment for middle of the night wakening: PDUFA date July 30, 2009.

UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09 (likely delayed requiring human factors testing for OptiNeb)

VRTX – Telaprevir ph-2 ‘C208’ trial testing BID vs TID dosing: EoT data: 1H09; SVR 2H09. (12-wk data were reported at AASLD).
VRTX – Telaprevir ph-3 ADVANCE, ILLUMINATE, and REALIZE trials: SVR data 1H10.

VRUS – R7128 & INFORM-1 all-oral HCV cocktail: see Roche.
VRUS – PSI-7851: report phase-1 data 2H09.
VRUS – HCV purine analogs: select lead compound(s) 2H09.

VVUS - Qnexa Pivotal trial data obesity (OB-302) Mid 2009
VVUS - Qnexa Pivotal trial data obesity (OB-3030 Mid 2009
VVUS - File NDA Qnexa obesity Late 2009

ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)
ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09
ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10

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