Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep these entries up to date! See
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Edits: AMLN (Byetta approved as monotherapy—entry deleted); HGSI (Benlysta); IDIX (miscellaneous updates); VRTX (‘C208’ data out—entry deleted).


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 done in late 3Q09 (not PR’d); no reply yet from FDA on possible priority review.
AGN – Botox for spasticity: reply to FDA’s CRL submitted in Oct 2009 (not PR’s); Class-2 response from FDA 1H10.

AMGN – Denosumab BLA: FDA issued CRL on 10/19/09. Prompt approval likely for treatment of osteoporosis; new trials required for prevention of osteoporosis. See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42814924 for additional details.

AMLN – Exenatide LAR: PDUFA date early Mar 2010 (NDA submitted 5/5/09 and accepted for review 7/7/09).

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.)

GILD – GS9190 HCV non-nucleoside polymerase inhibitor: start phase-1/2 combination studies with GS9256 protease inhibitor 1H10. (The refocusing of the GS9190 program and the existence of GS9256 were disclosed on GILD’s 3Q09 CC: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42717806 .)
GILD – Elvitegravir phase-3 vs Isentress: complete enrollment 4Q09.
GILD – ‘Quadro’ phase-2: report primary-endpoint data (24 weeks) end 2009.
GILD – GS9450 (caspase inhibitor to inhibit fibrosis): report phase-2a data at AASLD (the HCV study, not the NASH study)
GILD – TMC278 + Truvada combo pill: complete bioequivalence studies and submit NDA/MAA 2H10 simultaneously with, or soon after, JNJ’s NDA/MAA submissions for standalone TMC278.

HGSI – Albuferon: submit BLA/MAA 4Q09. (Data from 2nd phase-3 trial reported 3/9/09.)
HGSI – Benlysta in SLE: submit BLA/MAA early 2010. (Data from 2nd phase-3 trial reported 11/2/09.)

IDIX – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=43072451 .

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 – TMC278 for HIV: report phase-3 data early 2010; submit NDA/MAA mid 2010. (See GILD me TMC278 + Truvada combo pill.)
JNJ – TMC278 + Truvada combo pill: see GILD.
JNJ – Xarelto: reply to FDA’s CRL 4Q09.
JNJ – PurTox botulinum toxin: 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.

TSPT – Intermezzo: CRL requesting add’l safety data issued by FDA 10/29/09.

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 NDA in first- and second-line settings: 2H10.
VRTX – VX-222 (f/k/a/ VCH-222) HCV polymerase inhibitor: report 3-day monotherapy data late 2009; MAYBE report outcome of VX-222+Telaprevir DDI study late 2009/early 2010.
VRTX – Telaprevir ± VX-222: start phase-2 combo study 4Q09; report interim data (not SVR) mid 2010.
VRTX – VX-813 and VX-985 2nd-gen HCV PI’s: maybe report PK data mid 2010. (VRTX appears to have downgraded the importance of these compounds since the acquisition of VX-222 from ViroChem.)
VRTX – VX-509 JAK3 inhibitor: start 12-week phase-2 trial in RA 1Q10, interim data 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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