Replies to post #160598 on Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: BAX (Gammagard fails in phase-3 AD trial—entry deleted).


ABT – ‘Absorb’ bioresorbable stent: US launch possible in 2013, pending clinical results. (Launched in 30 countries including EU 9/25/12.)

AMGN – Xgeva sBLA submission for bone health in non-metastatic cancer: 2013 pending results of phase-3 trial in breast cancer.

AMRN – Vascepa (f/k/a AMR101) approved by FDA 7/26/12; decision on NCE status pending.

BMY – Eliquis: see PFE.
BMY – Yervoy phase-3 in 2nd-line CRPC: data mid 2013.

GILD –‘Quad Prime’ based on TAF (f/k/a GS-7340): Data from two phase-2 studies early 2013—one tests Quad Prime vs Atripla and one tests Quad Prime vs Prezista + Cobicstat + Truvada. (Ph2 testing Quad Prime vs Stribild reported 10/31/12.)
GILD – “Standalone” Evitegravir NDA: FDA issued CRL on 4/29/13; no further details available. (Note: Evitegravir is one of the component drugs in Stribild.)
GILD – “Standalone” Cobicstat NDA: FDA issued CRL on 4/29/13; no further details available. MAA submitted 5/23/12; no further info available. (Note: Cobicstat is one of the component drugs in Stribild.)

IDIX – IDX719 (NS5A inhibitor, now IDIX’s lead drug): 3-day PoC phase-1b monotherapy data reported 6/20/12.

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

JNJ – Xarelto sNDA in PCI sub-indication of ACS: PDUFA date should have been in Mar 2013 (sNDA resubmitted 9/7/12).

LGND - Promacta for HCV: EU MAA submitted 5/30/12. (Approved by FDA 11/19/12.)

MNTA – See
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=87469957

PFE – Eliquis: sNDA in VTE prevention 3Q13; sNDA in VTE treatment late 2013 pending outcome of AMPLIFY study, which will be presented at ISTH in Jun 2013. (Eliquis was approved for VTE prevention in EU in 2011.)

SNY – Aubagio for RRMS: MAA accepted for review 2/23/12; (approved by FDA 9/12/12). Lemtrada for RRMS: RTF issued 8/27/12; resubmission pending.

TEVA – Thrice-weekly formulation of Copaxone: timing of NDA unclear according to 6/14/12 PR announcing positive top-line results from GALA study.

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.)

XOMA – Data readouts from EYEGUARD-A/B/C phase-3 studies in uveitis: A (active NIU) end 2013; B (Behçet’s) mid 2014; C (maintenance NIU) 1Q14.

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