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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 | |||
| ShdittaresousanngOiditttponsosanngu | (S)19112AD7mm114m | |||
| 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
- • Approved for marketing (Sweden) October 2006
- 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
- • Reduces lung inflammation
- • 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)
