ABT – Certriad (Crestor+TriLipix): response to FDA’s CRL (issued 3/30/10) expected any day (source: 2Q10 CC).
ABT – Bioresorbable DES: EU launch expected 2013 (pending successful pivotal trial); no guidance yet on US launch.
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 advisory panel 12/3/10. AGN – Botox for OAB: sBLA submission made Oct 2010; no word yet on priority review; data presentation at urology conference in 2011. AGN – Latisse for androgenetic alopecia: formulation work in progress; start phase-1 trial late 2011.
AIS - Anturol NDA file by ye10, partnership timing? AIS - Methotrexate autoinjector file IND 2010, clinical studies early 2011 AIS - First TEVA undisclosed pen injector ANDA file late 2011
AMGN – Denosumab: Already approved by FDA and EU for treatment of osteoporosis; PDUFA date for BLA in treatment of bone mets 11/18/10; data from phase-3 trial to prevent bote mets in HRPC (http://clinicaltrials.gov/ct2/show/NCT00286091 ) 4Q10; BLA submission for bone health in non-metastatic cancer 2012-2013.
AMLN – Bydureon (exenatide LAR) second-pass PDUFA date 10/22/10. (Original CRL issued by FDA 3/15/10.)
ANDS – ANA598 phase-2a trial: SVR12 data for patients re-randomized to 12 weeks of SoC: 3Q10 (200mg cohort), 4Q10 (400mg cohort); SVR12/SVR data for patients re-randomized to 24 weeks of SoC: 1H11.
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 vs warfarin in AF/stroke prevention: data from phase-3 ARISTOTLE study Apr 2011. 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 12/25/10; 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 – Standalone Elvitegravir: report phase-3 Elvitegravir-vs-Isentress primary-endpoint (48-week) data early 2011.
GILD – TMC278+Truvada combo pill: submit NDA/MAA 4Q10. GILD will submit the NDA as soon as the FDA accepts JNJ’s TMC278 NDA for review; bioequivalence studies were completed 4/27/10. (See JNJ for further TMC278 info.)
HGSI – Benlysta in SLE: PDUFA date 12/9/10. (FDA advisory panel endorsed approval by 13-2 vote on 11/16/10.)
INHX – INX-189 HCV polymerase inhibitor: start phase-1b 3-day monotherapy trial early 4Q10; prelim data from phase-1b late 4Q10; final data from phase-1b 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: FDA issued a CRL requesting a new trial on 5/4/10; EMEA initial response to MAA soon (MAA submitted 3/2/10, initial response had been expected early Jul 2010).
JNJ – Xarelto: reply to FDA CRL in VTE prevention (received May 2009) expected in late 2010; initial NDA submission in AF (based on ROCKET-AF data reported 11/15/10) expected late 2010.
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 4Q10 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 NDA submission late 2010. MRK – Isentress sNDA submission for qD dosing in treatment-experienced setting: 2011. 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
NVS – Gilenya: EU approval likely in late 2010 or early 2011 based on Dec 2009 MAA submission. (FDA approved Gilenya 9/21/10.)
ONTY – Phase-3 trial in Stage III NSCLC: first interim analysis (at 50% of deaths relative to trigger for final analysis): 2H10.
OREX – Contrave NDA: FDA advisory panel 12/7/10, PDUFA date 1/31/11.
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: results from ph-3 trials in AMD 4Q10.
Roche – Ritonavir-boosted Danoprevir (RG7127) with SoC: phase-2b was supposed to start in 4Q10 (recently delayed from 3Q10); however, a new phase-1 PK study makes it doubtful that the phase-2b trial will actually start in 2010 (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53624063 ).
Roche – INFORM-3 trial of Donoprevir + RG7128 with SVR endpoint: start 1H11; it was delayed from a 2H10 start on ITMN’s 2Q10 CC 7/27/10 (I’m skeptical that it will start at all—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 patent litigation: see MNTA. TEVA –“Low-volume” Copaxone: PDUFA date 1/1/11. TEVA – Thrice-weekly formulation of Copaxone: study to start recruiting patients soon (http://clinicaltrials.gov/ct2/show/NCT01067521 ).
TEVA – Laquinimod for MS: potential US launch in mid 2012.
VRTX – Telaprevir+SoC: Complete Telaprevir NDA submission in first- and second-line settings: 4Q10.
VRTX – Telaprevir + VX-222: report phase-2 interim safety, efficacy, and PK data 2H10; SVR data 1H11. (Low-dose all-oral arm was dropped 10/25/10.)
VRTX – VX-509 JAK3 inhibitor: phase-2 interim data 2H10 (trial started Jan 2010).
VRUS – RG7128 and INFORM-n series of trials: see Roche. VRUS – PSI-7977: present final phase-2a data at conference in 2H10, presumably AASLD (top-line results were reported via presented 5/4/10); start 12-week phase-2b trial 4Q10. VRUS – PSI-938: report phase-1 data 3Q10. VRUS – PSI-661 (f/k/a PSI-879): file IND/CTA 4Q10.
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