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SYNTARA LIMITED AGM Information 2007

Nov 4, 2007

65830_rns_2007-11-04_b96d656b-5410-4ff7-b959-6386736bb035.pdf

AGM Information

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Therapeutic products Therapeutic products for respiratory and for respiratory and autoimmune diseasesautoimmune diseases

November 2007Annual General Meeting

Summary Summary……

Objitecev Thdlfdfidttteeeopmenoprocsorrespraoranvuyiditaommneseasesuu
Lddteaproucs fCOAidlhdPDttromanagemenoasmaan:COBhilhififibidPDttttroncoerapecorcscrossan:uy
Discoervy PXSlilli64tmpescerossu-
Liitsngs S()SSQ()SAXN2003PXNADAA200PXL5ogv:;u:
Litocaon SdNSWAlitnesraayyu,,
Filitacy GffMPMlddttanuacureoeaproucs
Elmpoeesy 70
Ch(//)30607as $Ailli78mon
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Ktteypaens Aidl&BhildiUSAAliAiditttroroncogranenusraasa;penng,,CiEUddJnanaaanapan,
Altnayscoverage

Development Pipeline Development Pipeline

Milestones achieved FY2007 Milestones achieved FY2007…..

1 AidlMkiAliiFildiSitttroarengppcaonenerwz ldan Jl2006uy
2 USAidlTilClroraoses
3 fGPhiAiAidlDiibtttarmaxspponsrosruororr eece O2006tc
4 fCUKAlPh3iFibiTitpprovaoraseyscrossra lidreceve O2006tc
5 fAidlDiibIlAidttttrosruororayppone O2006tc
6 SifidhAlAdlespproaorrowv O2006tc
7 GGAidlEddilblidlironorsenoauenes N2006ov
8 SUAidlPhIIIltroaseresus N2006ov
9 SBhilRiFTkttttroncoecevesasracaus N2006ov
10 DhDiibfAidlAidttttcsrororopponeuu D2006ec
11 SihDiibfAidlAidtttpanssrororopponeu J2007an
12 CPhIIIBhilTillEttaseroncoraompeesnro ltmen Fb2007e
13 PhIICFSdClEllttaseosesnromenuy Fb2007e
14 PhIIAidlCOPDRlRdttaseroesseporeu M2007ar
51 PhIIICiFibiTilBitasescrossraegnsy A2007pr
16 AidlCOPDSdElFiPittttronrosrsaenuy M2007ay
17 iiAdlGEAlroansropeanpproauv J2007nu

Milestones achieved since end FY2007Milestones achieved since end FY2007…….

1 CPhIIIBhiiTillttaseroncecassraompee Jl2007uy
2 KNDAfildfAidloreaneorro Jl2007uy
3 iiiiffiPhIIITlFdPh'BhlEttaseransarmasroncoecexv A2007gu
4 SPldhPhPltacemenanarercaseanu O2007tc
5 KDiibidfAidltttoreansrorapponeorrou O2007tc
6 fAhddiittttgreemenreaceoepanmanacrngcapacxuuy N2007ov

Bronchitol Bronchitol

Mucus clearance:Mucus clearance:

Cystic fibrosis Cystic fibrosis Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease BronchiectasisBronchiectasis

Osmotic clearance of abnormal mucusOsmotic clearance of abnormal mucus……

Before treatment

Lung surface dehydrated Lung hydrated

Airway surface fluid layer impaired Airway surface liquid restored Lung defense and hygiene compromised Normal lung clearance

After Bronchitol administration

Bronchitol Bronchitol – cystic fibrosis cystic fibrosis

•Background

  • •Genetic disorder affecting 75,000 worldwide (30,000 in US)
  • •Poorly hydrated, tenacious, thick mucus
  • •Current life expectancy is 37 years (US)
  • • Current treatments: rhDNase and tobramycin
    • •Delivered by nebulizer (preparation, sterilization)
    • •rhDNase (pulmozyme): US$265mm @ ~30% penetration
    • •Tobramycin: US$233mm

  • • Clinical
    • •Phase II proof of concept studies completed
    • •Dose range finding study in progress (Canada/Argentina)

Bronchitol Bronchitol – cystic fibrosis registration (I)....... cystic fibrosis registration (I).......

  • Phase III trial (Aus, NZ, EU):
    • •90 out of 250 subjects enrolled
    • •Primary endpoint: - lung function (FEV1)
    • •Placebo-controlled, 6 month dosing, 400mg bd
    • •First data expected end 2008
    • •Market - 2009
  • Orphan Drug designation in the EU

Bronchitol Bronchitol –cystic fibrosis registration (II)....... cystic fibrosis registration (II).......

  • •US Phase III trial design being finalised with FDA
  • •Expected to commence 1Q 2008
  • •Similar size, design to EU trial
  • •Scheduled completion 2H 2009
  • •Orphan drug designation – EU and U.S.
  • •Fast track designation – U.S.

Bronchitol Bronchitol - bronchiectasis bronchiectasis

  • •Abnormal, irreversible dilation of the lower airways
  • • Daily mucus production, constant coughing, breathlessness, recurrent acute bronchitis with infective exacerbations : low quality of life
  • •In 30-50% of cases, the cause is unknown
  • •Normal lung clearance impaired
  • •Current treatments: bronchodilators, antibiotics
  • Nodrugs proven effective to clear mucus

Number of patients seeking treatment Number of patients seeking treatment

EU Alitsraau SUA Aisa Tltoa
f%ltoppooseenibtrespraoryyilitspecass Average14% 9% /NA Average%5
Tdren Sbltaeoriincreasng Sbltae Iincreasng Sbltaeordiecreasng
Md/Soeerev %55 0%7 %55 %75
Pikittaensseengtttreamen 210000, 18000, 110000, 250000++, 600000+,
PlMhhihBhiiifidbhbdtttreaencecger.roncecasssoenmsseaseenmeasreasv:uuu

10% of COPD patients in a US patient cohort ~ 800k

Note: US Data comes from Datamonitor research, other data from Frost & Sullivan research

Bronchitol Bronchitol – bronchiectasis Phase III trial completed bronchiectasis Phase III trial completed….

  • Phase III trial (Europe, Australia, NZ)
    • • 363 patient, placebo controlled, double blind, randomised 12 week treatment. 12 month Open Label Extension
    • •320mg twice a day

  • • Primary endpoints
    • •quality of life – validated Patient Reported Outcome
    • •mucus clearance – 24hr sputum volume
  • •Primary Analysis
  • •Mucus Clearance

Quality of Life SGRQ, p<0.001 versus baseline SGRQ, p<0.05 versus placebo ↑28%, p<0.001 versus placebo Adverse Events not significant versus placebo

Bronchitol Bronchitol – second bronchiectasis PIII trial second bronchiectasis PIII trial….

•Phase III trial (USA)

  • • 375 patient, placebo controlled, double blind, randomised, 26 week treatment
  • •400mg twice a day
  • • Primary endpoints
    • •quality of life – validated Patient Reported Outcome
    • •mucus clearance – 24hr sputum volume
  • • Status
    • •Special Protocol Assessment discussion with FDA
    • •Orphan Drug designation
    • •Target first patient enrolment Q1 2008
    • •Target last patient enrolment Q4 2008
    • •Data 2H 2009

Impact of Bronchitol on people living with bronchiectasis Impact of Bronchitol on people living with bronchiectasis

AridolTM

A rapid and simple test for airways inflammation that facilitate A rapid and simple test for airways inflammation that facilitates diagnosis and management of asthma. diagnosis and management of asthma.

Clinical applications for Aridol Clinical applications for Aridol

An easy to use, 'point of care' test with a high degree of sensitivity (85%) and specificity (95%) for airway inflammation

  • 1.Asthma diagnosis and assessment of disease severity Asthma diagnosis and assessment of disease severity1
  • 2. Monitor patient Monitor patient's disease / managing ef s disease / managing effectiveness of treatment fectiveness of treatment 2
  • 3. Identification of COPD patients Identification of COPD patients who will respond to steroids who will respond to steroids 3

NOTES: 1 = Evidence available from phase III study 2 = Proof of concept only; definitive studies ongoing 3 = Evidence available from phase II study

International Regulatory Status International Regulatory Status

  • Australia
    • •Launched June 2006
  • Europe
    • • Approved for marketing (Sweden) October 2006
    • • Approved European Union (MRP) May 2007
    • •Submitted – Switzerland
    • •Regional marketing partners appointed
  • South East Asia
    • •Submitted - Korea
  • USA

•Phase III completed. NDA to be filed 1Q08

Launched January 2007 1st Launch September 2007

Aridol distribution agreements to date Aridol distribution agreements to date …

Ctonruy Ptarner iReevw ilNtaona
Sd•ween Nidgaar dapprove 9
Fild•nan Nidgaar dapprove
G•ermany TBA dapprove
Ildrean• Phiarmasx dapproev 9
Norway• Nidgaar dapprove
Pltorga•u TBA dapproev
UK• Phiarmasx dapproev
F•rance dapprove
G•reece Allterec dapprove
Ilta•y Ilhiiitacmc dapproev
Hlldoan• Rdiomec dapproev 9
Sipan• AldUionon- dapproev
Dkenmar• Nidgaar dapprove 9
Sildteran•wz Tidlrmea Udinerreevw
ShKt•ouorea BH&L Udinerrevew

Worldwide development of Aridol Worldwide development of Aridol……

Aridol in Australiain Australia…..

Quarter Sales

Steady growth in Australia

  • Price sensitivities
  • Aridol challenges current practice
  • Sales by education
  • Australia represents
  • ~1% global opportunity
  • Slow EU approvals have had an impact

Research and Development activities Research and Development activities …..

  • • PXS25 for immune disease
    • • Reduces lung inflammation
      • •Acute lung injury (ARDS), chronic lung injury (COPD)
    • • Preclinical work completed
      • •1st human exposure Q1 2008
  • • Research group in North Ryde
    • •Target protein identified
    • •Potent, selective inhibitors discovered
    • •Research in progress

Near term catalysts ahead Near term catalysts ahead …..

Miltesone 4Q07- 1Q08- 2Q08- 3Q08-
Bhilbhiittroncoroncecass-
FiliUSlihFDAttnaseproocow
CPhIII(US)ommencease
Filt mkil(A)1tsearengappnus
Bhil –ifibittroncocyscross
PIIdiild(C/A)ttosngraaaanrg
ClEUPIIIilitttoserarecrumen
CUSPhIIIiltommenceasera
iAdlro
(S)FilNDAUe
Filiitaces
Nfiliibitttewacyconsruconegns
PXS25/64
Clliildittompeeprecncasesu

Financial Statements Financial Statements – Australian GAAPAustralian GAAP

Ydd30Jeareneune
2005 2006 2007
SItttncomeaemens $A'000 $A'000 $A'000
ffRldevenueromsaeogoos - 8 205
Cfltososaes - ()2 ()49
Gfitrosspro - 6 165
Ohiterncome
Ittneres 1702, 4282, 5278,
Gitranncome 1219, 1299, 2125,
Ohter - - -
Expenses
Rh&dltesearceeopmenv ()9269, ()16978, ()23840,
Cilommerca ()963 ()1946, ()3240,
Adiiittmnsraon ()3134, ()4391, ()4666,
Tltoaexpenses ()13366, ()23315, ()31746,
fNlbtteosseoreax ()10445, ()12877, ()24160,
Itncomeaepensexx - ()5 ()19
Nlfttteossaerax ()10445, ()13377, ()24197,
$()Biddildilhtascanueearnngsosspersare- ()0084 ()0111 ()0136
Dii&iittteprecaonamorsaon 646 947 939
fFilliidtarvaueoempoyeoponsssue 260 1488, 1488,

Financial Statements Financial Statements – Australian GAAP Australian GAAP

Atsa
30J05un-- 30J06un-- 30J07un--
BlShtaanceees $A'000 $A'000 $A'000
Chdhiltasancaseqaensuv 33390, 97840, 76182,
Pl&ittanequpmen 2477, 3205, 3215,
Iiblttnangeasses 1106, 1195, 1239,
Tlttoaasses 39377, 104267, 82648,
Tllibiliittoaaes ()2407, ()3957, ()6089,
Tlhhld'ittoasareoersequy 34657, 98888, 76559,
ShDtareaa '000 '000 '000
Odihirnarsaresonsseyu 134770, 169047, 194977,
Oiitponsonsseu 10914, 9692, 9836,

Share Capital Capital –post 2007 equity issue post 2007 equity issue

(including options)