[Please keep these entries up to date! See the updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: BMY (change in Apixaban submission strategy—see #msg-59322062).
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.
ADLR-ADL5747 (post-herpetic neuralgia) p2a early 2011 (failed previous trials in other pain indications, but start of p2b would trigger $15m payment)
AGN – LapBand label expansion: FDA approval likely in early 2011 (positive FDA advisory panel 12/3/10). 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 NDA file by ye10 AIS - Methotrexate autoinjector file IND 2010, clinical studies early 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.
BPAX – LibiGel: 2,500 pt enrollment 10/18/10, no safety concerns again at latest DSMB review, but low CV event vs forcast means insufficient non-inferiority statisitical power, continue enrolling and will assess after each subsequent CV event. Avg pt exposure was 10.7 months at this date, need to extend to 12 months. Would hit maximum 4000 pts enrolled early 2011.
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 – IDX899: see GSK. IDIX – IDX184/IDX320: possible lifting of FDA clinical hold 1H11. IDIX – NS5A inhibitor: select lead compound 1H11 (was supposed to be 2010).
INHX – INX-189 HCV polymerase inhibitor: start phase-1b 3-day monotherapy trial early 4Q10; data early 2011.
ISIS - Select generation 2.5 chemistry by ye10 ISIS - GSK1 [undisclosed target] start p1 late 2010 or early 2011 ISIS - Mipomersin NDA/EU filings 1h11 ISIS - CRP start p2 trials in multiple myeloma, RA, autologous BM transplant 4q10-early 2011 ISIS - Factor XI start p1 4q10 ISIS - ApoCIII start p1 4q10 ISIS - PTP1b start 26wk p2b study 1h11, HbA1c data ye11 [but have been silent on this lately] ISIS - GCGR, GCCR start p1 late 2010 or early 2011 ISIS - SGLT2 p1 data 2010 and p2 2011 ISIS - LLY218108 Survivin cancer data late 2010, potential p3 2011 ISIS - eIF4E p2 start 4q10 in mPC, NSCLC, HCC 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).
MRK – Boceprevir: PDUFA date May 2011 (NDA has priority review).
MRK – Remicade/Simponi arbitration: see JNJ.
MYRX - Azixa initiate new p2b in newly-diagnosed GBM 4q10 MYRX - complete p1 for -3100 HSP90 inhibitor by ye10 MYRX - oral anti-interferon and cancer metabolism inhibitor candidates INDs by 6/30/11
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: NDA submission 1H11 (top-line data reported 11/22/10).
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
SUPG - SGI-110 (Dacogen follow-on) start p1 trial late 10 or early 2011 in MDS and elderly AML
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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