[Please keep these entries up to date! See the updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: REGN (VEGF-Trap-Eye BLA submitted in AMD).
ABT – Bioresorbable DES: EU launch 2H12 (following reimbursement negotiations—product already approved); US launch possible in 2013 (pending clinical results).
ACHN – ACH-1625 PI: start phase-2a trial Sep 2010; report 12w data end 2011. ACHN – ACH-2684 PI: file IND 1H11; phase-1b data end 2011. ACHN – ACH-2928 NS5A: file IND 1H11; phase-1b data end 2011. ACHN – Start all-oral ACH-1625 + ACH-2928 program 2012.
AGN – Botox for OAB: sBLA PDUFA date Aug 2011 (standard review); data presentation at urology conference in 2011. AGN – Latisse for androgenetic alopecia: phase-1 data early 2012.
AIS - Anturol PDUFA ~ Oct 2011 AIS - First TEVA undisclosed pen injector ANDA file late 2011
AMGN – Xgeva: BLA submission for prevention of bone mets in CRPC 1H11 (top-line phase-3 data reported 12/13/10); BLA submission for bone health in non-metastatic cancer 2012-2013, pending results of phase-3 trial in breast cancer.
AMLN – Bydureon (exenatide LAR) second-pass PDUFA date 10/22/10. (Original CRL issued by FDA 3/15/10.)
Bayer – Xarelto: see JNJ. Bayer – VEGF-Trap-Eye: see REGN.
BMY – Apixaban vs aspirin in AF/stroke prevention: NDA rolling submission based on AVERROES study to be completed in 1Q11. BMY – Apixaban in AF/stroke prevention: data from phase-3 ARISTOTLE study 2Q11; NDA submission (based on ARISTITLE AND AVERROES) 2H11. BMY – Apixaban for VTE prevention appears to be on the back burner (or dead). In Dec 2009, BMY/PFE said a European MAA would occur in 1H10 (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44219816 ), but nary a peep about VTE prevention since then.
BMY – Belatacept: FDA decision on BMY’s response to May 2010 CRL is on hold until BLA fixes manufacturing problems in Puerto Rico.
BMY – Ipilimumab in second-line metastatic melanoma: PDUFA date 3/26/11. (ODAC panel originally scheduled for 2/9/11 was canceled.) European MAA submitted and accepted by EMA for review. BMY – Ipilimumab in first-line metastatic melanoma: data from phase-3 ‘024’ trial testing DTIC±Ipi expected 1Q11. BMY – Ipilimumab in melanoma brain mets: OS data from phase-2 ‘042’ trial 2011 (RR data reported at 2010 ASCO). BMY – Ipilimumab in NSCLC/SCLC: OS data from phase-2 ‘041’ trial 2011 (PFS data for NSCLC reported at 2010 ASCO). Decision has been made to advance to phase-3 in NSCLC.
CHTP - Droxidopa in ADHD PII : Due Q1 11 CHTP - Droxidopa in NOH in Parkinsons pts only PIII Study 306 : Due Q2 11. CHTP - CH-4051 Interim PII in RA : Due Q3 11 CHTP - Droxidopa in Fibromyalgia : Due Q4 11
GILD – Elvitegravir vs Isentress phase-3: report 96-week 1H12. (Duration for primary endpoint was changed from 48w to 96w on 1/10/11.).
GILD – ‘Btripla’ TMC278+Truvada combo pill: NDA submitted to FDA 11/23/10; FDA decision on priority review Jan 2011. Btripla MAA submitted to EU 9/3/10. (See JNJ for further TMC278 info.)
GSK – ‘761 (IDX899) for HIV: start phase-2b vs Sustiva in first-line HIV early 2011. (The SONNET phase-2b trial in second-line HIV started Nov 2010.) GSK – Benlysta: see HGSI.
HGSI – Benlysta in SLE: PDUFA date 3/10/11 (extended by three months on 12/3/10).
IDIX – NS5A inhibitor: select lead compound 1H11 (was supposed to be 2010).
INHX – INX-189: final phase-1b monotherapy data late 1Q11.
ISIS - GSK1 [undisclosed target] start p1 late 2010 or early 2011 (still waiting) ISIS - Mipomersin NDA mid-2011 HoFH only, EU filing 1h2011, HoFH and severe HeFH ISIS - CRP start p2 trials in multiple myeloma, RA, autologous BM transplant 4q10-early 2011 (still waiting) ISIS - PTP1b start 26wk p2b study ???? [odds decent that this becomes next candidate ditched for more potent backup ISIS - GCGR, GCCR start p1 late 2010 or early 2011 (still waiting) ISIS - SGLT2 p1 data 2010 and p2 2011 (still waiting) ISIS - LLY218108 Survivin cancer data late 2010, potential p3 2011 ISIS - SOD1 registrational p2 in ALS niche begin 2011
ITMN – Pirfenidone: No specific timeline for response to FDA’s CRL of 5/4/10 requesting a new trial. (Pirfenidone approved by EU’s CHMP 12/17/10.)
JNJ – TMC278 for HIV: PDUFA date May 2011 (assuming a standard review—NDA submitted 7/26/10). MAA submission 3Q10. (See GILD re TMC278+Truvada combo pill.) JNJ – Remicade/Simponi arbitration with MRK Dec 2010, decision expected early 2011.
JNJ – Nevo drug-eluting stent: EU submission late 2010; FDA submission 2012.
JNJ – PurTox botulinum toxin: submit BLA 2011 after completing two phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)
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 1Q10 CC).
JNJ – Telaprevir: see VRTX.
LGND - Promacta p3 HCV data 2h11 LGND - p38 inhibitor BMS add'l p2 trial 2011 LGND - Aprela menopause NDA 2011 LGND - SCH527123 (MRK) CXCR2 antagonist p2 COPD is enrolled, data early 2012 LGND - Dinaciclib (MRK) CDK inhibitor, multiple cancer p2 ongoing, report late 2010 thru 2012 LGND - LGD-4033 SARM inhibitor- p1b completing, data 2q11 and partner soon thereafter
LLY – Bydureon: see AMLN.
MDVN – Dimebon: see PFE.
Merck KGaA – Cladribine NDA in RRMS: PDUFA date 12/5/10. (Rejected in Europe 9/24/10.)
OREX – Contrave PDUFA date 1/31/11. (FDA advisory panel endorsed approval by 13-7 vote on 12/7/10.)
PFE – Apixaban: see BMY.
PFE – Bapineuzumab: see JNJ.
PFE – Dimebon: AD program terminated 5/10/10 except the CONCERT study testing Aricept±Dimebon in mild-to-moderate AD. HORIZON study in HD continues.
REGN - Rilonacept in flare prevention upon initiation of allopurinol - results expected in 2010; Rilonacept in flare treatment - results expected in 2010.
REGN - Aflibercept in 3 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred)
REGN – VEGF-Trap-Eye in AMD: PDUFA date Dec 2011 assuming standard review (BLA submitted 2/22/11).
Roche – RG7128 + SoC: Phase-2b (separate from PROPEL study) testing regimens with 24w of RG7128+SoC in geno-1/4 started enrollment Feb 2010. Phase-2b in geno-2/3, originally planned to start 2H10, will supposedly start in 1H11 ( see http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58513484 ).
Roche – INFORM-SVR trial of Danoprevir (RG7127) + RG7128 with SVR endpoint will supposedly start in 1Q11. [I’m skeptical that it will start at all—Dew.]
Roche – Danoprevir + SoC: Phase-2b was supposed to start in 2010. [I think the program is probably dead—Dew.]
SPPI - Belinostat (CUP w/ chemo) complete p2 ye10 and release data 3q11 SPPI - Belinostat (PTCL monotherapy) NDA 2011 [but very little comment on enrollment, etc] SPPI - Belinostat initiate p2 NSCLC trial 4q10 SPPI - submit sNDA to remove Zevalin bioscan requirement 4q10 SPPI - Fusilev CRL response filed 10/29/10, pending acceptance by FDA
TEVA – Copaxone and Lovenox litigation: see MNTA. TEVA –“Low-volume” Copaxone: FDA issued CRL 12/23/10; no further info available. [I question whether this program has any future—Dew.] TEVA – Thrice-weekly formulation of Copaxone: phase-3 GALA study results expected Nov 2012. TEVA – Laquinimod for MS: results of phase-3 BRAVO study expected 3Q11.
VRTX – Telaprevir PDUFA date 5/23/11.
VRTX – Telaprevir + VX-222: report phase-2 interim safety, efficacy, and PK data 1Q11. (Note: this trail no longer has any arms testing Telaprevir + VX-222 without either SoC or ribavairin.)
VRTX – VX-509 JAK3 inhibitor: phase-2 interim data 2H10 (trial started Jan 2010).
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