Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep these entries up to date! See
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Edits: BMY (Sprycel approved in 1st-line CML—entry deleted); VVUS (FDA issues CRL for Qnexa—entry deleted).


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-ADL5849 and 5747 (osteoarthritis) p2a 3q10
ADLR-ADL5747 (post-herpetic neuralgia) p2a early 2011

AGN – LapBand label expansion: FDA advisory panel 12/3/10.
AGN – Botox for OAB: sBLA submission 2H10; data presentation at urology conference in 2011 (no PR).
AGN – Next-gen neurotoxin for pain: start phase-2 trial 2H10(?).
AGN – Latisse for androgenetic alopecia: formulation work in progress; start phase-1 trial 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 enrollment target reached 10/18/10, triggering first unblinding of safety data to ascertain if further enrollment is needed to get enough safety events.

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

CORT – Corlux: last patient will be dosed next week, efficacy results 4Q10, timeline slip for NDA submission to 1Q11: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=51692765
CORT - CORT 108297 Phase I initiated in February, original guidance was for 2Q10 completion. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46958126

ELN – Bapineuzumab: see JNJ.

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: advisory panel 11/16/10, PDUFA date 12/9/10.

HRBR – Triolex for obese insulin resistant patients: data from obese cohort released and notice of new studies on specific effects on liver and muscle glucose uptake:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=49963156

IDIX – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=55627515 .

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.

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 – 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 – Xarelto: reply to FDA’s CRL in VTE prevention (received May 2009) expected in late 2010 (source: 2Q10 CC). Phase-3 data in AF/stroke prevention expected Nov 2010.

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).

JNJ – Telaprevir: see VRTX.

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.)

MNTA – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=55781224 .

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 - MPC4326 (HIV) p2b complete 1q11

NVS – Gilenya: EU approval likely in late 2010 or early 2011 based on Dec 2009 MAA submission. (FDA approved Gilenya 9/21/10.)

NVAX – H1N1 VLP vaccine 1,000 patient “stage A” trial in Mexico data complete and submitted to Mexican authorities. 3500 patient “stage B” completed enrollment in early March: http://finance.yahoo.com/news/NOVAVAX-Announces-Positive-prnews-4040674703.html?x=0&.v=1
NVAX – BARDA funding decision awaits site inspection… update in conference call, site inspection complete.
http://finance.yahoo.com/news/NOVAVAX-Notified-by-prnews-1260458837.html?x=0&.v=1
NVAX – seasonal trivalent head to head phaseIIb vs. Fluzone. see:
http://finance.yahoo.com/news/Novavaxs-Seasonal-Influenza-prnews-3904001081.html/print?x=0

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 – RG7128 + SoC: EoT data at AASLD from phase-2b PROPEL study that tests ‘12+12” and ‘8+16’ regimens in geno-1/4. Separate phase-2b 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, may be dead—see http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53150504 .)

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) p2 data by ye10
SPPI - Belinostat (PTCL monotherapy) NDA 2011

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.

TRBN - TRU015 (RA) 1st p2b re-treatment add'l data 11/10 at ACR
2nd p2b final data 11/10 at ACR

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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