Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: BMY/PFE (Eliquis approved by CHMP for AF).


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=78298188 .

AGN – Latisse for androgenetic alopecia: phase-2 data in men and women at unspecified medical conference in 2013.

AMGN – Xgeva sBLA submission for bone health in non-metastatic cancer: 2012-2013 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.

BIIB – BG-12 for MS: PFUFA date (std review): 12/28/12; MAA pending—no further info available.

BMY – Eliquis in AF/stroke prevention: FDA CRL issued 6/25/12—BMY expects to respond in Sep 2011 (according to 2Q12 CC)—no new trials needed; approved by CHMP 9/21/12.
BMY – Eliquis in VTE prevention: approved in EU 3/18/11—commercial launch in most countries by end of 2012; pursuit of this indication in US appears to be dead (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58061618 ).
BMY – Yervoy phase-3 in 2nd-line CRPC: data mid 2013.

EXEL – Cabozantinib for MTC PDUFA date 11/29/12 (no ODAC).

GILD – HCV program (GS-7977, GS-5885): see description of various trials and dates in http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77952062 .
GILD – “Standalone” Evitegravir: NDA submitted 6/27/12, awaiting decision on priority review.
GILD – “Standalone” Cobicstat NDA submitted 6/28/12; MAA submitted 5/23/12.
GILD – GS-7340/’Quad Prime’: Two phase-2 studies ongoing with data in late 2012 or 2013—one tests Quad Prime vs Atripa and one tests Quad Prime vs Prezista + Cobicstat + Truvada.

IDIX – IDX719 (NS5A inhibitor): 3-day PoC phase-1b monotherapy data reported 6/20/12; NVS now has exclusive option to license IDX719 with a decision expected in about 3 months. (IDX184 and IDX19368 are on FDA clinical hold.)

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

JNJ – Xarelto NDA for VTE treatment/secondary prevention: on or about 11/2/12; Xarelto NDA in PCI sub-indication of ACS resubmitted 9/7/12.
JNJ – Zytiga PDUFA for sNDA in pre-chemo CRPC 4/14/13.

LGND - Promacta for HCV: PDUFA date 11/30/12 (priority review); MAA submitted 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=79377345

NAVB – Lymphoseek CRL issued due to CMC issues 9/10/12.

PFE – Tofacitinib PDUFA date 11/21/12.
PFE – Bosutinib in CML: EU decision any day (MAA accepted for review 8/17/11); FDA approved 9/4/12.
PFE – Eliquis: see BMY.

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.

SPPI - Belinostat phase-3 data: 2012 (according to PR of 3/1/12).

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 – Initial monotherapy data on ALS-2158 around Sep/Oct 2012. (Initial data on ALS-2200 were reported on 7/30/12.) Intention is to combine these nukes.
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.)

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