Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep entries up to date! See
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Edits: MRK (Isentress sNDA’s for first-line setting and for qD dosing); SGP (Boceprevir NDA submission date).


ACHN – ACH-1095 (a.k.a. GS9525) HCV NS4A inhibitor: start phase-1 4Q08.
ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.

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.

Bayer – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)

BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.

CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.

DNDN – Provenge 9902b study: final analysis (304 deaths) mid 2009.

DYAX – DX-88 for HAE: PDUFA date 3/23/09.

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 by end 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.

IDIX – See #msg-32683478.

ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.

INSM - ALS update Q4'08 expanded access program in italy (likely before end of nov)
INSM - MMD IIb interim analysis Q4’08. IIb ends december 2008, final data Q1 09.(optin 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 INS submission Q4'08 (neupogen generic)
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 January 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.)

MAXY – See Bayer.

MNT – See JNJ.

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: 1Q09 (no further detail provided by co).

NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).

NVAX - Pandemic (bird) flu Phase IIa, final safety data complete 2008.

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 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
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)

PFE – Apixaban program: see BMY

Pharming – Rhucin submission to FDA late 2008; resubmission to EMEA with new data early 2009.

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 4/08.
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
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or 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: late 2008/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) late 4Q08; 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

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