Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: GILD (Truvada PDUFA extension in prevention indication).


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

ACHN – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=75415030 .

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

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.

BMY – Eliquis in AF: PDUFA date 6/28/12 (extended 3 months on 2/29/12).
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 ).
ELN – Bapineuzumab: see JNJ.

BMY – Yervoy in melanoma brain mets: OS data from phase-2 ‘042’ trial 2012 (?) (RR data reported at 2010 ASCO).
BMY – Yervoy in NSCLC/SCLC: OS data from phase-2 ‘041’ trial 2012 (?) (PFS data for NSCLC reported at 2010 ASCO). Decision has been made to advance to phase-3 in NSCLC. ).

GILD – PSI-7977: numerous data reports due in 2012 (too numerous to list here). .
GILD – 4-drug phase-2 all-oral HCV trial: SVR data early 2013.
GILD – Truvada HIV prevention PDUFA date 9/14/12 (positive FDA panel 5/10/12).
GILD – Quad PDUFA date 8/27/12 (positive FDA panel 5/11/12).
GILD – Evitegravir+Cobicistat *without* Truvada: NDA 2Q12.
GILD – “Standalone” Cobicstat as a general replacement for ritonavir: MAA submitted 5/23/12; NDA planned 3Q12.
GILD – GS-7340 (Viread enhancement): Data from phase-1b dose-ranging and phase-1 combo w Emtriva: 2Q11. (Phase-2 started 1/24/12.)

IDIX – IDX184: more phase-2b data at some unspecified time in 2012. (Removal of partial FDA clinical hold 2/3/12; interim data reported at EASL.)
IDIX – IDX719 (NS5A inhibitor): 3-day PoC phase-1b monotherapy trial started Apr 2012; NVS decision whether to opt-in due when trial is completed.

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

JNJ – Xarelto for ACS: PDUFA date late Jun 2012 (negative panel vote 5/23/12).
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 1Q11 CC).

LGND - Promacta NDA/MAA for HCV reviews pending (submissions made 5/30/12).
LGND - SCH527123 (MRK) CXCR2 antagonist p2 COPD is enrolled, data early 2012

MNTA – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=72859250

PFE – Tofacitinib PDUFA date Aug 2012 (positive FDA panel 5/9/12).
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: PDUFA date Oct 2012; EU decision mid 2012 (MAA accepted for review 8/17/11).
PFE – Eliquis: see BMY.
PFE – Bapineuzumab: see JNJ.

REGN – Zaltrap BLA in mCRC PDUFA date 8/4/12 (priority review).

SNTA – phase 2b ganetespib + docetaxel in NSCLC: 2Q12.

SNY – Aubagio for RRMS: PDUFA date Jun 2012; in EU, MAA accepted for review 2/23/12.

SPPI - Belinostat NDA 2012 (timeline slip)

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

VRTX – Phase-2b testing multiple (non-response-guided) protocols for Incivek + VX-222 + ribavirin in treatment-naïve genotype-1 to start 3Q12. (Data on no-IFN arms of ZENITH study reported 2/23/12.)
VRTX – Initial data on studies with ALS-2200 and ALS-2158: 2Q12.

VVUS – Qnexa PDUFA date: 7/17/12. (Positive advisory panel 2/22/12.)

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