[Please keep entries up to date! Items previously listed as 2008 events should be reentered as appropriate. Please see updating procedure at the end of this post.]
ACUS - Imagify PDUFA date Feb. 28, 2009; approval highly unlikely after panel rejection on 12/10/08.
AMLN – LAR: NDA submission date late 1H09. AMLN – Byetta monotherapy NDA: AMLN/LLY reported on 12/8/08 that FDA action will slip to an unspecified date in 2009.
ANDS – ANA598 (HCV non-nucleoside polymerase inhibitor) phase-1b monotherapy data from three cohorts 1Q09; start phase-2 mid 2009. ANDS – ANA773 (oral TLR7 activator) phase-1b HCV monotherapy data from 1st cohort 1Q09, all cohorts 2Q09; start phase-2 mid 2009.
ARYX – ATI-5923 (“enhanced warfarin”) phase-2/3 data mid 2009.
ELN – AAB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.) ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)
GENZ – Myozyme sBLA for second production site: PDUFA date 2/28/09. (Old PDUFA date of 11/19/08 was scrapped when FDA requested GENZ to submit protocol of a post-marketing study. The sBLA has been converted to an application under Subpart E accelerated approval.)
GILD – GS9525 HCV NS4A inhibitor: see ACHN. GILD – GS9190 HCV polymerase inhibitor: start phase-2 early 2009. (Prior guidance was late 2008; QT-prolongation deemed acceptable at 40mg BID dose, as announced on 3Q08 CC.)
GTCB – FDA advisory panel for ATryn: 1/9/07; PDUFA date 2/7/09.
HEPH - Triolex (HE3286) Phase II for type 2 diabetes should complete enrollment end of 2008, interim results Q1 2009. "TRIOLEX appears to act independently of the PPAR-gamma nuclear receptor and thereby may avoid the side effects associated with the current glitazone class of insulin sensitizing agents, such as Avandia(R) and Actos(R), which work through the PPAR-gamma pathway." Triolex Phase I/II for ulcerative colitis, complete enrollment Q1 2009, Data Q2 2009 Triolex Phase I/II Rheumatoid arthritis, complete enrollment Q1 2009.
HGSI – Albuferon: data from genotype-1 phase-3 trial Mar 2009. (Data from geno-2/3 trial were reported 12/8/08.) Submit BLA fall 2009.
INSM - MMD IIb interim analysis Q4’08. IIb ends december 2008, final data Q1 09. (opt-in moment at that time by ipsen/genentech) . INSM - NDGA phase II trial run by UCSF in prostate cancer started May 2008. Primary data May 2009. INSM - INS-19 P3 inititation Q1'09 INSM - INS-20 P1 data Q1'09
ITMN – ITMN191: see Roche. ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results Feb 2009 (72 week treatment period).
JNJ – PurTox: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)
LLY – Prasugrel FDA panel: 2/3/09.
MNTA – FDA decision on Lovenox ANDA: probably 1Q09 or early 2Q09 (response to FDA was submitted on 9/26/08). Amphastar’s 180-day exclusivity expires 4/1/09. MNTA – M118: report phase-2 data in stable angina: 2Q09; ink partnership deal: mid 2009. MNTA – Copaxone ANDA: end of 30-month stay Jan 2011.
MRK – Isentress sNDA for first-line setting: PDUFA date Jul 2009. MRK – Isentress sNDA for qD dosing: submission 2011. (Phase-3 trial called QDMRK started 4Q08: Isentress BID + Truvada vs Isentress qD + Truvada in first-line setting.)
MRX – FDA action date on Reloxin BLA: 4/13/09.
NVS – FTY720 FREEDOMS phase-3 trial: report data Jul 2009. (The FREEDOMS trial plus the TRANFORMS trial and the US subset from the FREEDOMS-2 trial will comprise the NDA package. TRANSFORMS, a 1-yr trial vs Avonex, hit its primary endpoint as reported on 12/12/08; FREEDOMS and FREEDOMS-2 have identical protocols with a 2-yr duration and a placebo control arm. Data from the US subset of FREEDOMS-2 will already be available and will be reported when FREEDOMS finishes.)
OXGN 1H 09 OXI4503 preclinical data in liquid tumors OXGN 1H 09 Initiate OXI4503 Phase 1 (AML and liver tumors) OXGN 1H 09 Initiate Zybrestat ophtamology study OXGN 1H 09 Final Phase 2 data in Zybrestat ovarian cancer OXGN 2H 09 Interim Zybrestat NSCLC Phase 2 data OXGN 2H 09 OXI4503 Phase 1 data (solid tumors)
Pharming – Rhucin submission to FDA early 2009 (?) (guidance had been late 2008); resubmission to EMEA with new data after FDA submission.
PIP – Phase-1 Protexia results 2Q09.
RDEA – Start phase-2b combination study of RDEA806 in HIV: 1Q09; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 1Q09.
Roche – INFORM-1 all-oral HCV cocktail: 2-week data at EASL 4/09. Roche – ITMN-191 data from 14-day triple- combination study: Jan 2009. Roche – R7128: phase-2a 28-day EoT data mid 2009; start phase-2b 1Q09.
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by early 1Q09) RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09) RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR for 48-week arms: early 2009. (SVR for the 28-week arms and SVR12 for the 48-week arms were reported at AASLD.) Boceprevir NDA: 2011-2012 (based on SGP’s Nov 2008 R&D Day).
SNTA - Elesclomol Phase III metastatic melanoma: Safety and Futility Interim Analysis (PFS); Complete enrollment (630) ~ early 1Q09; final PFS analysis (primary endpoint) early 2009; interim OS analysis early 2009 (secondary endpoint)
SOMX - PDUFA date of SILENOR for insomnia: 2/28/09.
UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09 UTHR - FREEDOM-M top line results End of March, 2009
VRTX – Telaprevir ph-2b PROVE-3 trial in treatment-experienced HCV: SVR data in all arms 1H09. (SVR12 for Telaprevir arms and EoT data control arm were reported at AASLD.) VRTX – Telaprevir ph-2 ‘C208’ trial testing BID vs TID dosing: EoT data: 1H09; SVR 2H09. (12-wk data were reported at AASLD). VRTX – Telaprevir ph-3 ADVANCE trial: dosing of all 1050 patients complete Jan09; SVR data 1H10. VRTX – VX-500 second-generation PI for HCV: phase-1b data 1Q09.
VRUS – R7128 & INFORM-1 all-oral HCV cocktail: see Roche. VRUS – PSI-7851 2nd-gen nuke for HCV: file IND 1Q09.
VVUS - Qnexa Pivotal trial data obesity (OB-302) Mid 2009 VVUS - Qnexa Pivotal trial data obesity (OB-3030 Mid 2009 VVUS - File NDA Qnexa obesity Late 2009
ZGEN – IFN-Lambda ph-1b: EoT data from 3mcg monotherapy cohort and 1.5mcg combination cohort at EASL Apr 2009. ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008. ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09) ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09 ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10. ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
-- Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical order.
3. Near the top of the message, list the ticker symbols of the entries you changed (e.g. “Edits: GILD IDIX MNTA”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
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