SYNTARA LIMITED — AGM Information 2008

Oct 22, 2008

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Therapeutic products for respiratory diseases

Annual General Meeting 23 October 2008

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Summary……
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Objective The development of products for respiratory and inflammatorydiseases Lead products Aridol: management of asthma and COPD Bronchitol: therapeutic for cystic fibrosis and COPD Discovery PXS25 (IGFII antagonist). PXS4159 (VAP1 inhibitor) Listings ASX (Nov 2003): PXS; NASDAQ (Aug 2005): PXSL Location Sydney, NSW, Australia Facility GMP Manufacture of lead products Employees 100 Cash (30/09/08) $106 million Shares outstanding 195m (12 9m ADS) Options outstanding . 13.0m Key patents Aridol & Bronchitol granted in USA, Australia, Asia, Canada, Japan; pendingin EU,Japan. Analyst coverage Lodge

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Year in review through milestones passed…..
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1.	Phase 3 bronchiectasis trial positive	Aug 2007
2.	Placement and Share Purchase Plan raised $62m	Oct 2007
3 .	Korean distributor appointed for Aridol	Oct 2007
4.	Commenced construction of new manufacturing plant	Dec 2007
5.	Concluded preclinical safety for PXS25	Dec 2007
6.	US office opened	Dec 2007
7.	First Asian Aridol approval - Korea	Jan 2008
8.	China accepts Bronchitol clinical trial application	Mar 2008
9.	Aridol for elite athletes accepted by Olympic Committee	Mar 2008
10.	CF trial in children returns positive results	Apr 2008
11.	Aridol approved in Germany	May 2008
12.	Agreement with FDA and EMEA on Phase 3 bronchiectasis trial	Jun 2008
13 .	Ph 2 CF d i l l i i ase ose tr a resu ts pos t ve	A 2008 ug
14.	Phase 3 CF trial completes recruitment	Aug 2008
15.	12 month Phase 3 trial finds Bronchitol safe in bronchiectasis	Aug 2008
16 .	Second CF Phase 3 trial (under SPA) commences recruitment	Sep 2008
17.	Bronchiectasis marketing application filed with TGA	Sep 2008
18.	Aridol approved in Switzerland	Oct 2008

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Development Pipeline
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-----------Clinical Trial Phases-----------

Research preclinical phase I phase II phase III registration market

Aridol – asthma (Aus/EU)

Aridol – asthma (USA) Bronchitol – bronchiectasis (Aus) Bronchitol – bronchiectasis (US,EU) Bronchitol – cystic fibrosis (EU) Bronchitol – cystic fibrosis (US) Bronchitol – acute indications PXS25 – lung fibrosis PXS4159 – asthma

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PXS4159 – asthma
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Bronchitol
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Mucus clearance: Cystic fibrosis Chronic Obstructive Pulmonary Disease Bronchiectasis

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Osmotic clearance of abnormal mucus……
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Before treatment

After Bronchitol administration

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representation
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representation
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Lung surface dehydrated

Lung hydrated

Airway surface fluid layer impaired

Lung defense and hygiene compromised

Airway surface liquid restored Normal lung clearance

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Bronchitol – cystic fibrosis
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• 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): global sales US$440mm (2007)

• Tobramycin: global sales US$233mm (2007)

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Bronchitol for CF – near term revenue opportunity (I)…..
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• Time line to market –

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EU PIII EU PIII EU
trial trial data dossier
closes available filed
File
Q4 08 Q4 09 • EU – Q2 09
• US – Q2 10
US PIII US trial
starts closes US trial
data
available
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• Regulatory matters addressed

• European agreement to file using Centralised Procedure

• Orphan drug status means one trial sufficient for approval (EU)

• Trial conducted under Protocol Assistance from EMEA

• US trial conducted under SPA

• Fast Track status allows filing of a US rolling NDA

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Bronchitol for CF – near term revenue opportunity (II)…..
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Commercial readiness - pre marketing commenced

• Less than 500 CF centres world wide

• 10 staff

• Top 5 countries in Europe can be covered b y

• Tight knit group (patients/carers/nurses/physicians)

• Reference p roduct in Euro p e is rhDNase (p ulmoz y me )

• ⇒ price, health economics

• 30,000 CF sufferers in Euro p e

• Year 1 target uptake – 30%

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Bronchitol for CF – commercial strategy…..
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• 2008/9

• Hand over of relationships from Clinical team (US , UK , AUS)

• Build relationships with US CF Foundation

• Boost trial participation willingness (market PXS)

• Build support for future FDA / pricing negotiations

• Build relationships with other CF associations

• 2009/10

• Intensive publication/awareness strategy

• Sales teams recruited 6 months rior to EU/AUS launch p

• Appoint distributors for non core markets (outside EU top 5)

• 2010/11

• Launch Year

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Bronchitol – cystic fibrosis registration (I).......
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• 1[st] Pivotal Phase III trial

• Multicentre, double blind, comparator controlled

• Enrollment complete and closed at 325 subjects

• 6 month treatment, 400mg twice per day

• Primary endpoint: lung function (FEV1)

• Secondary endpoint: exacerbation frequency, antibiotic use

• • Top line efficacy data expected 1H 2009

• European marketing application via centralised procedure

• Filing and dossier review plan to be agreed with EMEA

• Earliest approval 1H 2010

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Bronchitol – cystic fibrosis registration (II).......
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• 2[nd] Pivotal Phase III trial

• Protocol review throu g h S p ecial Protocol Assessment ( FDA )

• Double blind, comparator controlled

• 300 subject 6 years and older

• 400mg, twice per day for 6 months

• 1[o] endpoint - lung function by spirometry (FEV1)

• 2[o ] endpoints – antibiotic use, exacerbations, lung function

• Enrolment commenced

Sep 2008

• First data

2H 2009

• Orphan drug designation – U.S.

• Fast track designation – U.S.

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Bronchitol - bronchiectasis
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• 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

• C urrent treatments: ronc b h o dil ators, ant ibi ot cs i

• No drugs proven effective to clear mucus

1: Clin Pulm Med 2005;12:205

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Bronchitol – bronchiectasis registration (I)…
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• First Phase III trial com lete p

• Quality of life ↑: Sputum volume ↑: Antibiotic use ↓: Safe (12 months)

• Marketing Application filed in Australia

• Possible approval

Q3 2008 Q3 2009

• Available on Special Access Scheme

• One Phase III trial required for US and Europe

• Protocol agreed with Europe regulatory agency

• Protocol agreement with US FDA via SPA

• • Cost of trial - $10 million

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Bronchitol – bronchiectasis registration (II)….
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• 2[nd] Pivotal Phase III trial

• 350 patient, placebo controlled, double blind, randomised, 52 week treatment

• 400mg twice a day

• Primary endpoint

• Reduction in number of exacerbations

• Quality of life

• Secondary endpo ni ts

• Exercise, mucus clearance, antibiotic use

• Status

• Special Protocol Assessment concluded with FDA

• Orphan Drug designation

• Tar et commencement g

• Data

USA Q4 2008 2010

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Number of bronchiectasis patients seeking treatment
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EU Australia USA Asia Total
% of pt poo seen l A verage 9% N/A A verage
by respiratory 14% 5%
specialists
Trend Stable or Stable Increasing Stable or
increasing decreasing
Mod/Severe 55% 70% 55% 75%
Patients seeking
210,000 18,000 110,000 250,000 ++ 600,000+
treatment
Prevalence: Much higher. Bronchiectasis is often missed but has been measured as
>10% of COPD patients in a US patient cohort ~ 800k
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Note: US Data comes from Datamonitor research, other data from Frost & Sullivan research

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Bronchitol – acute clearance of lung secretions
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ICU, hospitalized patients and ventilated patients

• Currently supplied on request to patients with life threatening condition

• Feedback encouraging for proof of concept study

• Clinical conditions include: asthma, COPD, cystic fibrosis, secondary respiratory disease, neurogenic disorder

Objective

• acute care ilot stud p y

Q 2 2009?

• study in ventilated patients

Q2 2009?

Market opportunity

• 1 million U.S. emergency room visits every year (COPD alone)

• 60,000+ ICU beds worldwide 80 - 90% occupancy rates

• 75% patients ventilated / 75% have serious mucus problem

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

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Clinical applications for Aridol
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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[1]

2. Monitor patient’s disease / managing effectiveness of treatment[2]

3. Identification of COPD patients 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

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International Regulatory Status - Aridol
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• Australia

• Launched June 2006

• • Europe • Approved European Union (MRP) May 2007 • Regional authorizations complete

• • Regional marketing partners appointed • Europe wide launch Oct 2008

• • South East Asia • Approved for marketing – Korea January 2008 • Pricing approval expected early 2009

• • USA

• Phase III trials completed

• • New Drug Application being assembled

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Aridol: current distribution agreements…
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	Country Partner Regulatory Status
	S d Ni d d l h d • we en gaar approve aunc e • Finland Nigaard approved launched • Germany to be advised approved pricing • Ireland Pharmaxis approved launched
	• Norway Nigaard approved launched • Portugal Pulmocor approved launched • UK Pharmaxis approved launched
	• France approved planning • Greece Allertec approved launched • Italy Italchimici MRP • Holland Romedic approved launched
	• Spain Aldo-Union approved launched • Denmark Nigaard approved launched • Belgium MRP • Switzerland Trimedal approvable • Korea BLH approved pricing

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Growth Opportunities ahead: Aridol
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Timin g Portugal, Finland, Norway, Spain, Germany Q3 2008 France, Italy, Korea Q1 2009 USA Q3 2009 New data – Asthma management Q1 – Q4 2009

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Aridol revenue potential
Addressable Market
Market share
10%
20%
75%
s)
n
.a. (millio
p
Tests
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Worldwide development of Aridol……
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Sweden - 1
Norway - 9
UK - 9
Denmark - 7
Canada - 1
Germany - 1
USA - 3 Spain - 1 Greece - 1
NL - 1
Switzerland - 11
Total:
59 clinical studies
10,000 patients Australia - 15
High level of Investigator driven
interest worldwide
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R&D - Status (PXS-25)
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• Small molecule from Pharmaxis

• M6P receptor antagonist inhibiting TGFβ1 activation

• Preclinical toxicology complete

• Phase 1 trial to commence end 2008

• Development plan and partnering strategy

• d eve op l PXS 25 f or pu monary n l i di ca ti on

• out-license PXS-25 for non-core indications / territories

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R&D - Status (PXS-4159)
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• Small molecule from Pharmaxis

• Selective and potent inhibitor of SSAO/VAP-1

– potential indications include, asthma, COPD, ocular inflammation

• Highly orally bioavailable

� Preclinical development commenced

• Phase 1 trial expected mid-2009

� Development plan and partnering strategy

– develop PXS4159 for pulmonary indications

• out-license PXS4159 for non-core indications / territories

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Near term catalysts ahead…..
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Milestone 4Q-08 1Q-09 2Q-09 3Q-09
Bronchitol – cystic fibrosis
1 [st] P III trial complete
1 [st] PIII trial data
Close 2 [nd] P III trial enrollment
File MAA in EU (central)
Bronchitol – bronchiectasis
MAA decision (Aus)
Start 2nd P III trial enrollment
Complete 2 [nd] PIII enrollment
Aridol
File NDA (US)
Facilities
New facilit y com p lete ( buildin g)
PXS25
Commence Phase 1 program
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Pharmaxis target profile – June 2009
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• 1[st] Phase 3 Bronchitol cystic fibrosis study completed

• Marketing application submitted in Europe through centralised procedure

• 2[nd] Phase 3 Bronchitol CF tr ai l fully enrolled

• Pre-marketing commenced in US

• Clinical data available for Bronchitol ventilator indication

• Bronchitol approval for bronchiectasis pending in Australia

• PXS25 completed Phase I trial demonstrating safety and PK profile

• Moving into Phase II for IPF

• PXS4159 preclinical safety completed

• Moving into Phase I clinical trial

• Aridol approval pending in the US

• Marketing capability assembled and pre launch activities active

• Aridol launched throughout Europe

• New facility operational

• Bronchitol 2[nd] Phase 3 bronchiectasis trial in recruitment

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Financial Statements
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Income Statements Revenue from sale of goods Cost of sales Gross profit Other income Interest Other income Expenses Research & development Commercial Administration Total expenses Net loss before tax Income tax expense Net loss after tax Earnings (loss) per share $ - Depreciation & amortisation Fair value of employe options issued	Income Statements Revenue from sale of goods Cost of sales Gross profit Other income Interest Other income Expenses Research & development Commercial Administration Total expenses Net loss before tax Income tax expense Net loss after tax Earnings (loss) per share $ - Depreciation & amortisation Fair value of employe options issued
	Income Statements Revenue from sale of goods Cost of sales Gross profit Other income Interest Other income Expenses Research & development Commercial Administration Total expenses Net loss before tax Income tax expense Net loss after tax Earnings (loss) per share $ - Depreciation & amortisation Fair value of employe options issued		2005 A$'000 - -		2006 2007 A$'000 A$'000 Year ended 30 June 8 205 (2) (49)	2008 A$'000 527 (129)
					2006 A$'000 8 (2)
			- 1,702 1,219 (9,269) (963) (3,134)		6 156 4,282 5,278 1,299 2,152 (16,978) (23,840) (1,946) (3,240) (4,391) (4,666)	398 7,402 1,576 (19,996) (4,557) (5,231)
			(13,366)		(23,315) (31,746)	(29,784)
			(10,445) -		(17,728) (24,160) (5) (19)	(20,408) (32)
			(10,445)		(17,733) (24,179)	(20,440)
			(0 084) . 646 260		(0 111) (0 136) . . 947 939 1,488 1,488	0 108 . 1,024 3,434

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Financial Statements
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Financial Statements	Financial Statements
Balance Sheets Cash and cash equivalents Plant & equipment Total assets Total liabilities Contributed equity Total shareholders' equity Share Data Ordinaryshares on issue Options on issue										30 J 08 - un- A$'000 111,842 3,668 125,049 (5,928) 194,680 119 121 , '000 194,515 11,536
	Balance Sheets Cash and cash equivalents Plant & equipment Total assets Total liabilities Contributed equity Total shareholders' equity Share Data Ordinaryshares on issue Options on issue	30 J 0 - un- 5 A$'000 33,390 2,477 37,937 (2,470) 54,716 35 467 , '000 134,770 10,914			30 J 06 30 J 0 As at - un- - un- 7 A$'000 A$'000 97,840 76,182 3,205 3,521 104,267 82,648 (5,379) (6,089) 134,745 135,108 98 888 76 559 , , '000 '000 176,904 177,949 9,692 9,836					30 J 08 - un- A$'000 111,842 3,668 125,049 (5,928) 194,680 119 121 , '000 194,515 11,536

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Employee Headcount at June 2008
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Admin, 6
Commercial, 13
Clinical, 29
Drug Discovery,
7
Manuacturing,
35
Australia UK USA China Total
76 9 4 1 90
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Sales
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600
500
400
300
200
100
0
2006 2007 2008
Australia Euro p e Clinical Trials
$,000
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New Facility
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• Key Dates

• Construction commenced Nov 2007

• Base building complete Dec 2008

• Fit-out complete April 2009

• Manufacturing plant fully validated Q4 2009

• • D eve oper l /L an dl or d : GE R ea l E s a e us t t A t

• Lease term: 15 years + 2 x 5 year options

• • Pharmaxis cost for fit-out, manufacturing capacity: $20m

• Initial Capacity: 72,000 Bronchitol doses pa

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Share Capital
(including options)
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Management – 5%

Other/retail – 35%

Institutions – 49%

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VC’s – 2%

ADRs – 9%

30 September 2008: 194.5m shares; 12.9m options