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Generic name(Brand orReference number)

Manufacturer Status PredictedIndication(s)

Doses Studied

(assume inadults unless

specified)

ProductPresentation

Drug Class Website / AdditionalInformation

Amadacycline(PTK -796)

Novartis /Paratek

Phase II CSSIOnce daily

dosingPO/IV Aminomethycycline

http://www.novartis.com/downloads/research/planned-

filings.pdfhttp://www.paratekpharm.com

/pt_pipeline.html

Amikacin inhaled

powder (NKTR-061/ BAY 41-6551)

Nektar/Bayer Moving intoPhase III Gram negativepneumonia 400 mg every12 -24 hours INH Aminoglycoside

http://www.nektar.com/produc

t_pipeline/all_phases.html

Amikacinliposomal(Arikace)

TransaveInhalational

BiotherapeuticPhase II

Pseudomonasinfections in cystic

fibrosis and non CFbronchiectasis

560mg oncedaily

INH Aminoglycosidehttp://www.transaveinc.com/p

roducts.shtml#amik

aztreonam lysineinhalation(Cayston)

GileadSciences

FDA approved2/13/2010.

Improve respiratory

symptoms in cysticfibrosis patients

with Pseudomonas

75 mg threetimes daily

INH Monobactam www.cayston.com

Ceftaroline Cerexa/ForestNDA submitted

in late 2009CSSI and

hospitalized CAP300-600 mg IVevery 12 hours

IVCephalosporin

with MRSAactivity

http://www.frx.com/research/pipeline.aspx

ciprofloxacin

inhaled powder(CIP, Cipro Inhale)

Nektar/Bayer Phase II

Use in cysticfibrosis patients

with recurrent P.aeruginosainfections

50 75mgCipro

PulmoSphereInhalationpowder BID x

28 days

INH Fluoroquinolone

http://www.nektar.com/produc

t_pipeline/all_phases.html

Clostridium difficileMAB

[MDX-066 (CDA-1) +MDX-1388 (CDA2)]

Medarex/BMS

Moving intoPhase III

CDAD10mg/kg eachadministered

togetherIV

MonoclonalAntibody

http://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-

781_T1.html

Antibiotic Pipeline Surveillance 2010 to mid 2011Cardinal Health Clinical Affairs

(Phase I and some early Phase II not included)

Copyright 2010 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.PROPRIETARY

1

http://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.paratekpharm.com/pt_pipeline.htmlhttp://www.paratekpharm.com/pt_pipeline.htmlhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.transaveinc.com/products.shtml#amikhttp://www.transaveinc.com/products.shtml#amikhttp://www.cayston.com/http://www.frx.com/research/pipeline.aspxhttp://www.frx.com/research/pipeline.aspxhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-781_T1.htmlhttp://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-781_T1.htmlhttp://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-781_T1.htmlhttp://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-781_T1.htmlhttp://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-781_T1.htmlhttp://www.nature.com/nbt/journal/v27/n9/fig_tab/nbt0909-781_T1.htmlhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.frx.com/research/pipeline.aspxhttp://www.frx.com/research/pipeline.aspxhttp://www.cayston.com/http://www.transaveinc.com/products.shtml#amikhttp://www.transaveinc.com/products.shtml#amikhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.nektar.com/product_pipeline/all_phases.htmlhttp://www.paratekpharm.com/pt_pipeline.htmlhttp://www.paratekpharm.com/pt_pipeline.htmlhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdf

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Generic name(Brand or

Reference number)Manufacturer Status

PredictedIndication(s)

Doses Studied(assume in

adults unlessspecified)

ProductPresentation

Drug ClassWebsite / Additional

Information

fidaxomicinpreviously Difimicin,

(OPT-80) andPAR101

OptimerPhase III

(plans to submit

NDA late 2010)

CDAD200 mg every

12 hours

PONovel Macrocycle

Antibiotic

http://www.optimerpharma.com/pipeline.asp?pipeline=1

isavaconazole(BAL8557)

Basilea/Astellas Phase III

Esophagealcandidiasis,Aspergillus,Candidiasis

Various dosesbeing studied

IV/POTriazole

Antifungal

http://www.basilea.com/Development/Isavuconazole/

peramavir Biocryst

Phase III(granted

Emergency Use

Access in 2009)

Influenza600 mg IV dailyfor 5-10 days

IV(IM trialfailed)

Neuraminidaseinhibitor

http://www.biocryst.com/peramivir

pleconaril(VP 63843)

Schering-Plough / Merck

Phase II

Cold and asthmaexacerbations

(INH), neonatalenteroviral sepsis

(PO)

Variousregimens

PO/INH Antiviral

http://www.merck.com/research/pipeline/SGP_Oct_Product

s-in-Development.pdf

prulifloxacin(OPT-99)

Optimer Phase IIIInfectious

diarrhea/travelerdiarrhea

600mg daily x 3days

PO Fluoroquinolonehttp://www.optimerpharma.co

m/pipeline.asp?pipeline=2

ramoplanin Nanotherapeutics Phase III CDAD200 or 400 mgevery 12 hours

POGlycolipodepsi-

peptide

http://www.nanotherapeutics.com/products_pipeline_ramo

planin.php

razupenem(PTZ601)

Novartis Phase IICSSI and

pneumoniaN/A IV

Carbapenem withMRSA activity

http://www.novartis.com/downloads/research/planned-

filings.pdf

SulopenemPfizer Phase II CAP

Variousregimens

PO/IV Carbapenemhttp://www.pfizer.com/files/research/pipeline/2009_0331/pip

eline_2009_0331.pdf

Copyright 2010 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.PROPRIETARY

2

Table Key:CAP = community acquired pneumonia, CDAD= Clostridium difficile-associated disease, CIAB Complicated intra-abdominal infections, CSSI = Complicated skin and structure Infection, HAP = Hospitalacquired pneumonia, MAB= monoclonal antibiody, UTI = Urinary tract infection, N/A = information not available. Information regarding future indications available at www.clinicaltrials.gov.

http://www.optimerpharma.com/pipeline.asp?pipeline=1http://www.optimerpharma.com/pipeline.asp?pipeline=1http://www.basilea.com/Development/Isavuconazole/http://www.basilea.com/Development/Isavuconazole/http://www.biocryst.com/peramivirhttp://www.biocryst.com/peramivirhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.optimerpharma.com/pipeline.asp?pipeline=2http://www.optimerpharma.com/pipeline.asp?pipeline=2http://www.nanotherapeutics.com/products_pipeline_ramoplanin.phphttp://www.nanotherapeutics.com/products_pipeline_ramoplanin.phphttp://www.nanotherapeutics.com/products_pipeline_ramoplanin.phphttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.pfizer.com/files/research/pipeline/2009_0331/pipeline_2009_0331.pdfhttp://www.pfizer.com/files/research/pipeline/2009_0331/pipeline_2009_0331.pdfhttp://www.pfizer.com/files/research/pipeline/2009_0331/pipeline_2009_0331.pdfhttp://www.clinicaltrials.gov/http://www.clinicaltrials.gov/http://www.pfizer.com/files/research/pipeline/2009_0331/pipeline_2009_0331.pdfhttp://www.pfizer.com/files/research/pipeline/2009_0331/pipeline_2009_0331.pdfhttp://www.pfizer.com/files/research/pipeline/2009_0331/pipeline_2009_0331.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.novartis.com/downloads/research/planned-filings.pdfhttp://www.nanotherapeutics.com/products_pipeline_ramoplanin.phphttp://www.nanotherapeutics.com/products_pipeline_ramoplanin.phphttp://www.nanotherapeutics.com/products_pipeline_ramoplanin.phphttp://www.optimerpharma.com/pipeline.asp?pipeline=2http://www.optimerpharma.com/pipeline.asp?pipeline=2http://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.biocryst.com/peramivirhttp://www.biocryst.com/peramivirhttp://www.basilea.com/Development/Isavuconazole/http://www.basilea.com/Development/Isavuconazole/http://www.optimerpharma.com/pipeline.asp?pipeline=1http://www.optimerpharma.com/pipeline.asp?pipeline=1

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http://www.eisai.com/pipeline.asp?ID=173http://www.pharma.novartis.com/research/pharmaceutical-product.shtmlhttp://www.advancedlifesciences.com/product.phphttp://www.acebiosciences.com/index.php?option=com_content&view=article&id=55&Itemid=65http://www.vrtx.com/current-projects/drug-candidates/telaprevir-VX-950.htmlhttp://phx.corporate-ir.net/phoenix.zhtml?c=119269&p=irol-newsArticle&ID=1350053http://phx.corporate-ir.net/phoenix.zhtml?c=119269&p=irol-newsArticle&ID=1350053http://www.pharmasset.com/pipeline/index.asphttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://media.pfizer.com/files/research/pipeline/2010_0127/pipeline_2010_0127.pdfhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.hgsi.com/albuferona.htmlhttp://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.viivhealthcare.com/en/r-and-d/our-pipeline.aspxhttp://www.tibotec.com/bgdisplay.jhtml?itemname=HIV_tmc278http://www.pharmasset.com/pipeline/racivir.asphttp://www.idenix.com/hepc/drug/http://www.gilead.com/researchhttp://www.gilead.com/researchhttp://www.pharmasset.com/pipeline/dexelvucitabine.asphttp://www.panacos.com/discovery_platforms.htmhttp://www.avexa.com.au/projects/hiv/avx754

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http://www.fiercebiotech.com/press-releases/fda-issues-ceftobiprole-complete-response-letterhttp://www.hgsi.com/abthrax-raxibacumab.htmlhttp://www.immtechpharma.com/http://www.merck.com/research/pipeline/SGP_Oct_Products-in-Development.pdfhttp://www.themedicinescompany.com/products_oritavancin.shtmlhttp://media.pfizer.com/files/research/pipeline/2010_0127/pipeline_2010_0127.pdfhttp://www.acino-pharma.com/html/uploads/media/Icla_PressRel_En_091104.pdfhttp://www.axentispharma.com/