Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: ABBV/ENTA, GILD


ABBV – All six ph3 trials of ABT-450 + ABT-267 + ABT-333 fully enrolled as of 7/26/13; NDA submission 2Q14 (same quarter as GILD’s NDA submission in GT1).

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.

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

ENTA – ABT-450 program: see ABBV.

GILD – Sofosbuvir + riba + pegIFN (for GT1) NDA: FDA advisory panel 10/25/13, PDUFA date 12/8/13.
GILD – ION-2 and ION-3 ph3 data (Sofobusvir + GS-5885 ± riba): 4Q13; ION-1 ph3 data (same regimen): 1Q14.
GILD – NDA submission for Sofosbuvir + GS-5885 ± riba: 2Q14.

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=90093590

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: Results October, 2013
PRAN - 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).

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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