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Clinical / Regulatory / Litigation Calendar

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Edits: AMGN (Xgeva ODAC); GILD (Quad PDUFA date); JNJ (Xarelto sNDA in ACS); VVUS (Qnexa advisory panel). ; CHTP (Droxidopa advisory panel)


ABT – Bioresorbable DES: EU launch 2H12 (following reimbursement negotiations—product already approved); US launch possible in 2013 (pending clinical results).

ACHN – ACH-1625: EVR data 4Q11.
ACHN – ACH-2928: final phase-1 data at EASL Apr 2012.
ACHN – ACH-3102: file IND 1H12
ACHN – Start *some* combination trial of a PI (ACH-1625 or ACH-2684) + NS5A (ACH-2928 or ACH-3102) in 2012.

AGN – Latisse for androgenetic alopecia: phase-2 data in men and women late 2012.

AIS - Methotrexate autoinjector file NDA 1q2012

ALNY - ALN-TTR01 phase 1 data 11/2011
ALNY - ALN-TTR02 IND 2h11
ALNY - ALN-PCS phase 1 data ye2011
ALNY - ALN-RSV interim sample size analysis by ye2011, data in 2012 regardless of outcome

AMGN – Xgeva sBLA for prevention of bone mets in CRPC: ODAC 2/8/12, PDUFA date 4/26/12.
AMGN – Xgeva sBLA submission for bone health in non-metastatic cancer: 2012-2013 pending results of phase-3 trial in breast cancer.

AMRN – AMR101 PDUFA date 7/26/12.

ANDS – See Roche.

ASTX - Dacogen for elderly AML PDUFA date 3/6/2012

AZN – Dapagliflozin: see BMY.

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

BIIB – BG-12 for MS: BLA submission 1H12.

BMY – Eliquis in AF: PDUFA date 3/28/12.
BMY – Eliquis in VTE prevention: approved in EU (3/18/11); no update on timing of possible FDA submission (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58061618 ).

BMY – Belatacept: FDA decision on BMY’s response to May 2010 CRL is on hold until BLA fixes manufacturing problems in Puerto Rico.

BMY – Yervoy in melanoma: European MAA pending (FDA approved Mar 2011).
BMY – Yervoy in melanoma brain mets: OS data from phase-2 ‘042’ trial 2011 (RR data reported at 2010 ASCO).
BMY – Yervoy in NSCLC/SCLC: OS data from phase-2 ‘041’ trial 2011 (PFS data for NSCLC reported at 2010 ASCO). Decision has been made to advance to phase-3 in NSCLC. ).

BMY – Dapagliflozin PDUFA date 1/28/12 (recently extended 3 months).

CHTP - Droxidopa in ADHD PII : Due Q1 11
CHTP - Droxidopa in NOH in Parkinsons pts only PIII Study 306 : Due Q2 11. (update: (FDA) has scheduled a meeting of the Cardiovascular and Renal Drugs Advisory Committee on February 23, 2012 to review the New Drug Application (NDA) for NORTHERA™ (droxidopa.)
CHTP - CH-4051 Interim PII in RA : Due Q3 11
CHTP - Droxidopa in Fibromyalgia : Due Q4 11

ELN – Bapineuzumab: see JNJ.

GILD – 4-drug phase-2 all-oral HCV trial: SVR data early 2013.

GILD – PSI-7977: 2012 news flow in http://finance.yahoo.com/news/Pharmasset-Reports-Fiscal-prnews-1153974923.html?x=0&l=1 . (TMC435 + PSI-7977 phase-2 all-oral started 4Q11.)

GILD – Quad PDUFA date (std review) 8/27/12.

GILD – Evitegravir+Cobicistat *without* Truvada: NDA 2Q12.

GILD – sNDA for Truvada in HIV prevention: submission 12/16/11, awaiting decision on priority review.

GILD – GS7340 (prodrug of tenofovir): phase-1b dose-ranging and phase-1 combo e Emtriva 2Q11.

IDIX – IDX184: phase-2b 30-day safety and VL data 1Q12. (Because of the prior clinical hold, FDA will examine the 3-day data for first 30 patients before allowing this trial to enroll additional patients.)
IDIX – IDX719 (NS5A inhibitor): file IND 4Q11.

ISIS - Mipomersin NDA 4q2011

ITMN – Pirfenidone: No specific timeline for response to FDA’s CRL of 5/4/10 requesting a new trial.

JNJ – Xarelto for ACS: sNDA submitted 12/29/11, awaiting FDA decision on priority review.

JNJ – Bapineuzumab: ‘301’/‘302’ (N. American) phase-3 trials conducted by JNJ: data in 2H12; int’l phase-3 trials conducted by PFE: data in 2014 (confirmed on PFE’s 1Q10 CC).

JNJ – Incivo (telaprevir) MAA in EU: action expected 2H11 (submission made 12/10).

JNJ – TMC435 + PSI-7977 HCV trial: see VRUS.

LGND - Promacta phase 3 data presentation AASLD 11/2011 and maybe ASH 12/2011; sNDA for HCV 2q2012
LGND - Aprela menopause NDA 2011
LGND - SCH527123 (MRK) CXCR2 antagonist p2 COPD is enrolled, data early 2012

MNTA – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=70251049 .

MYRX - MPC3100 HSP90 inhibitor phase 1 data EORTC 11/2011

NVS – generic Copaxone: see MNTA.

PFE – Tofacitinib PDUFA date Aug 2012.

PFE – Xalkori (crizotinib) in NSCLC: EU decision mid 2012 (MAA accepted for review 8/17/11). Approved by FDA 8/26/11.

PFE – Bosutinib in CML: NDA submission late 2011; EU decision 2012 (MAA accepted for review 8/17/11).

PFE – Eliquis: see BMY.
PFE – Bapineuzumab: see JNJ.

REGN – Zaltrap BLA in CRC withdrawn 12/21/11—resubmission by SNY planneed in 1Q12. Final phase-3 VENICE study in 1st-line CRPC (Taxotere±Zaltrap) mid 2012. Roche – ANA773: start phase-2a trial 4Q11.

SNY – Aubagio for RRMS: PDUFA date Jun 2012; EU MAA submission 1Q12.

SNTA - phase 2b ganetespib NSCLC data March-April 2012 SPPI - Belinostat (CUP w/ chemo) data by ye2011 (slip)

SPPI - Belinostat NDA 2012 (timeline slip)
SPPI - Apaziquone top-line data early 2012 followed by NDA in 2012

TEVA – Copaxone litigation: see MNTA.
TEVA – Thrice-weekly formulation of Copaxone: phase-3 GALA study results expected Nov 2012.

VRTX – Telaprevir MAA in EU: see JNJ.
VRTX – Incivek + VX-222 + ribavirin/SoC phase-2 SVR data late 2011/early 2012 (interim data reported 7/26/11). (Note: this trial no longer has any arms without either SoC or ribavirin.)

VRUS – See GILD.

VVUS – Qnexa FDA advisory panel 2/22/12.

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