Replies to post #163155 on Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: BMY/PFE (re Eliquis)


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 second sNDA in PCI sub-indication of ACS issued 6/28/13; a new-trial requirement seems likely in this indication.

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=87862037

PFE – Eliquis sNDA in primary VTE prevention: PDUFA date 3/15/14; Eliquis sNDA in VTE treatment & secondary prevention: FDA submission 3Q13. (Eliquis was approved for VTE prevention in EU in 2011.)

PRAN - Reach2HD Phase-2 for Huntington's disease: Last Patient to be Dosed June, 2013; Results anticipated October, 2013
- IMAGINE: Phase-2 imaging trial for Alzheimer's disease. Plaque positive prodromal and mild AD. Last Patient to be Dosed November 2013; Trial will be completed in December, 2013.

SNY – Lemtrada for RRMS: PDUFA date late 2013; (CHMP approval 6/26/13).

TEVA – Thrice-weekly formulation of Copaxone: PDUDA date Jan 2014 (assuming standard review).

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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