SYNTARA LIMITED — AGM Information 2009

Oct 20, 2009

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“Building a Healthy Future”

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Annual General Meeting October 2009

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Company Overview
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Objective The development of products for respiratory and inflammatory diseases Lead products Aridol: management of asthma and COPD Bronchitol: therapeutic for cystic fibrosis and COPD Discovery PXS25 (M6P receptor blocker). PXS4159 (VAP1 inhibitor) Listing ASX (Nov 2003): PXS Locations Sydney, NSW, Australia // Exton, PA, USA // Luton, UK Facility GMP Manufacture of lead products Employees (FTE) 108 Cash (30/09/09) A$113 million Shares outstanding 218m Options outstanding 15m Key patents Aridol & Bronchitol granted in USA, Australia, Asia, Canada, Japan; pendingin EU,Japan. Analyst coverage

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Year in review - milestones passed
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1.	Phase 2 CF dose trial results positive	Aug 2008
2.	Phase 3 CF trial completes recruitment	Aug 2008
3.	12 month Phase 3 trial finds Bronchitol safe in bronchiectasis	Aug 2008
4.	Second CF Phase 3 trial (under SPA) commences recruitment	Sep 2008
5.	Bronchiectasis marketing application filed with TGA	Sep 2008
6.	Aridol approved in Switzerland	Oct 2008
7.	New drug application for Aridol submitted to US FDA	Feb 2009
8.	Dr Howard Fox joins senior management team	Feb 2009
9 .	Richard van den Broek appointed director	April 2009
10.	Phase 3 CF trial demonstrates Bronchitol safe and effective	May 2009
11.	PXS25 presented at 2009 American Thoracic Society meeting	May 2009
12.	New factory and headquarters completed and occupied	May 2009
13.	European marketing application review timetable agreed with EU	June 2009
14.	Completion of $54 million capital raising	June 2009
15.	Pharmaxis delists from Nasdaq	July2009
16.	Second CF Phase 3 trial completes recruitment	Sept 2009
17.	Phase 1 trial of PXS25 commences recruitment	Oct 2009

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Pharmaxis Global Operations 2009
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D
Luton
-- 7 clinical7 marketing D
Pennsylvania D D D D - Shanghai2 commercial
- 4 commercial D
- 4 clinical/reg
Frenchs Forest
- 87 employees
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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/Korea) – Aridol asthma (US)

– Bronchitol bronchiectasis (Aus) – Bronchitol bronchiectasis (US/EU) – Bronchitol cystic fibrosis (EU/Aust) – Bronchitol cystic fibrosis (US) – Bronchitol acute indications PXS25 – lung fibrosis 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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Living with CF (Kate Smith)
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“My life expectancy is 31. I'm 29. So that's two years of parties, extreme sports and ” romance…

• The worst part of her disease:

• “I’d h ave o say t th e ex h aus ti on. Th e r gorous i exercise and physiotherapy regime required to help loosen the mucus on the lungs would tire anyone.

• It includes swimming, yoga, gym and physiotherapy where the rib cage is beaten with cupped hands. The reduced lung capacity makes it harder still to cope with everyday life let alone a full time job.

• The effect of absorbing a cocktail of drugs – up to 50 pills per day – plus inhalers also saps the energy ”

Daily Mail (UK); 24[th] June 2009

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Cystic Fibrosis market research
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The time commitment to treatment is the bi est challen e to h sicians and atients gg g p y p

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Time
Adherence
Financial
/discipline
Obstacles
to CF
treatment
Drug
Compliance
resistance
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•Time requirements and adherence to t h erapy are pervas ve c i h a ll enges -”the treatments take time. Although the payback is longevity and QOL, at the moment the treatments can take up a large part of the day.”

-”patients feel very pressed for time.” -”Because of the time requirement, you have to prioritise meds sometimes. Do the biggest bang for the commitment buck.” -”The time element is the key to adherence.”

-”Therapy gets in the way of daily activities – 50 minutes two times a day!”

• •Treatin g resistance to antibiotics is another challenge for physicians

Source: Willowdale market research

Bronchitol – the first CF specific dry powder

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CF-202 Dose Response 400 mg Selected
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• 48 subjects • Open label p<0.01 multidose study • 400mg twice a day, then 40, 120, 240mg t i d f w ce a ay or 14 days in a random order • Washout between doses

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DPM-CF-202
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Pharmaxis –Data on File [DPM-CF-202]

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CF-301 Absolute mean change (mL) in FEV1
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Bronchitol v Placebo over 26 weeks, p<0.001
160
∆118.9 mL (6.5%) for Mannitol
baseline to week 26
140
120
100 ∆77.7 mL ∆92.9 mL
(p<0.001) (p<0.001 )
80 ∆81.6 mL
(p<0.001)
60
40
20
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Weeks of Treatment
Least square means ( + SE) , adjusted for treatment group , age , week of study , rhDNase , baseline FEV1 , sex , baseline FEV1 predicted , region and treatment week
Bronchitol Placebo
(ml)
change in FEV1
Mean
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DPM-CF-301
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Pharmaxis –Data on File [DPM-CF-301]

The Children’s Hospital at Westmead unveil CF trial results

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Bronchitol story receives international attention

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Bronchitol: Target Product Profile
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Bronchitol:

• An easy, quick, portable dry powder inhaled drug that won’t interrupt cystic fibrosis patient’s daily schedules.

• Suitable for all ages and stages of cystic fibrosis

• Acts quickly to help clear mucus, producing a lasting benefit to lung function, reducing exacerbations and improving quality of life.

Market access Milestones:

• Phase 3 delivers Target Product Profile – May 2009

• Presentation of clinical trial results

  • Oral presentation at EU CF meeting

  • Oral presentation at Au CF meeting

  • Oral presentation at European Respiratory Society meeting

  • Oral presentation at North American CF meeting (October)

– EMEA submission

• Re q uest for accelerated review submitted – Se p tember 2009

• Marketing application submission – October 2009

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Bronchitol: commercial reality in CF
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Market access:

• Core Pricing & Reimbursement dossier – Q4 2009 (complete)

• National Pricing & Reimbursement dossier preparation - 2010

• EU National marketing specialists recruited - 2H 2009 / 1H 2010

• Sales team recruitment - Mid 2010

• NICE technolo a raisal rocess com lete – 2H 2010 gy pp p p

• Scientific advisory board consultation

• Patient advocacy group consultation

• Launch in German and UK after a roval y pp

• UK infrastructure in place

• Reimbursement discussion for rest of EU

Market

• Top 5 countries (including UK and Germany) – 27,000 CF patients • Addressable market is $350 million

• 350 CF Centres

• Required field force: 25 sales reps

• 15,500 CF patients in Germany and UK

• Addressable market is $200 million (at $13k/pt/yr)

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Bronchitol – commercialisation in the U.S.
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Clinical….

• Second pivotal Phase 3 trial closed to recruitment

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• 319 subjects recruited and data due 1H 2010

• same end point as first pivotal Phase 3 trial reported in May 09

Regulatory….

• tr a i l d i d w t i h FDA un d S i l P rotoco l A ssessment es gn agree er pec a

• fast track designation allows submission of rolling NDA

• opportunity for priority review

• response rom f FDA on NDA expec e t d m id 2011

• orphan drug provides 7 years market exclusivity

Marketing….

• promotion by PXS out of existing Philadelphia office

• unified approach to pricing and reimbursement

• 150 CF centres requires 15 person field force

• 30,000 people in the US with CF

• addressable market >$400 million

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Treatment Progression – CFF Guidelines
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Grade of recommendation Mild Moderate/Severe A rhDNase Benefit is substantial - Tobi(ifp.a.present) B Benefit is moderate rhDNase Tobi (if p.a. present) Hypertonic Saline Azithromycin (if p.a. present) Azithromycin (if p.a. present) Hypertonic Saline Ibuprofen (FEV1>60%) Inhaled B2 agonists Ibuprofen (FEV1>60%) Inhaled B2 agonists Insufficient evidence Other inhaled antibiotics Oral corticosteroids (18+ yr olds) Leukotriene inhibitors / cromolyn sodium. Anticholinergic bronchodilators N-acetylcysteine Against Inhaled corticosteroids (if asthma / ABPA absent) Oral corticosteroids(6-18yr olds)

There remains a lack of good quality long term studies evaluating existing treatments used in CF

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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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Number of bronchiectasis patients seeking treatment
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EU Australia USA Asia Total
% of t l A 9% N/A A
p poo seen verage 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
Note: US Data comes from Datamonitor research, other data from Frost & Sullivan research
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Bronchitol – bronchiectasis registration (I)…
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• 1[st] Pivotal Phase III trial

• 363 patient, placebo controlled, double blind, randomised 12 week +

• treatment (twice per day) 12 month open label extension

• Primary endpoints

• quality of life – validated Patient Reported Outcome

• mucus clearance – 24hr sputum volume

• Primary Analysis

• quality of Life

SGRQ, p<0.001 versus baseline SGRQ, p<0.05 versus placebo

• mucus clearance

• antibiotic use reduction

• adverse events (52 wks)

• 30%, p<0.001 versus placebo p<0.05 versus placebo

• cough 9%, sore throat 5% no SAE attributed to treatment

• First marketing application filed (Aus) in Sep 2008

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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

• Second d i ts ary en po n

• Exercise, mucus clearance, antibiotic use

• Status

• Special Protocol Assessment concluded with FDA

• Orphan Drug designation

• Tar et commencement g

• Data

USA October 2009 2011

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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 strong for proof of concept study

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

Objective

• acute care p ilot stud y ( investi g ator led )

Q 4 2009

• study in ventilated patients (PXS sponsored)

Q2 2010

Market opportunity

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

• Price $200 per day  $500 million per year

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

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Aridol™
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• Identifies airway reactivity (active airway inflammation ) which helps physicians in the diagnosis and management of asthma

• An easy-to-use test kit provides rapid results and doesn’t re q uire s p ecialized e q ui p ment

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International regulatory status - Aridol
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• Australia

• First market to launch

• 50% penetration in 2 years

June 2006

• Europe

• Approved European Union (MRP)

May 2007

• Regional marketing partners appointed

• Launches underwa y

• South East Asia

• Approved for marketing – Korea

Jan 2008

  - Pricing approval completed Sep 09

• USA

• NDA submitted. Complete response expected

Dec 2009

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Aridol – growth markets
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	USA KOREA GERMANY ExistingMarket 200,000 testsp.a. 120,000 testsp.a. 660,000 testsp.a. size Pricing +++ + ++ Market drivers Physician Physician Physician reimbursement reimbursement reimbursement Private physician market. Private physician market Entryroute Pharmaxis Distributor Distributor	USA KOREA GERMANY ExistingMarket 200,000 testsp.a. 120,000 testsp.a. 660,000 testsp.a. size Pricing +++ + ++ Market drivers Physician Physician Physician reimbursement reimbursement reimbursement Private physician market. Private physician market Entryroute Pharmaxis Distributor Distributor	USA KOREA GERMANY ExistingMarket 200,000 testsp.a. 120,000 testsp.a. 660,000 testsp.a. size Pricing +++ + ++ Market drivers Physician Physician Physician reimbursement reimbursement reimbursement Private physician market. Private physician market Entryroute Pharmaxis Distributor Distributor	USA KOREA GERMANY ExistingMarket 200,000 testsp.a. 120,000 testsp.a. 660,000 testsp.a. size Pricing +++ + ++ Market drivers Physician Physician Physician reimbursement reimbursement reimbursement Private physician market. Private physician market Entryroute Pharmaxis Distributor Distributor
		USA	KOREA	GERMANY
	ExistingMarket	200,000 testsp.a.	120,000 testsp.a.	660,000 testsp.a.
	size
	Pricing	+++	+	++
	Market drivers	Physician	Physician	Physician
		reimbursement	reimbursement	reimbursement
		Private physician market.		Private physician market
	Entryroute	Pharmaxis	Distributor	Distributor

	Steroid Management TRIAL Data ACRN ‘BASALT’ study Q1 2009, Q1 2010 EU steroid response 1H 2010 EU steroid titration 1H 2010

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Aridol Sales
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$600
$500
$400
$300
$200
$100
$0
2006 2007 2008 2009
Australia Europe Asia Clinical Trials
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R&D - Status (PXS-25)
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 Inhibits cleavage of latent TGF to active TGF

 anti-fibrotic agent with anti-inflammatory properties

 small molecule with robust pharmaceutical profile

• clinical target is pulmonary fibrosis

 500,000 cases and no approved drugs  Phase 1 trial commenced October 2009  data due end 2009

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Chief Financial Officer David McGarvey

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Manufacturing Capacity
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• Current GMP facility

• Manufactures Aridol for sale in EU, Asia & Australia

• Manufacture Bronchitol for clinical trials

• New facility

• Relocated May 2009

• Equipment installation & validation complete - Q4 2009

• Complete process validation – Q2 2010

• Capacity

  • Initial capacity - 1 spray drier:

40,000 patients p.a.

• Expanded capacity – 2nd spray drier: 80,000 patients p.a.

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Manufacturing
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Central sections of spray drier

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• M anu ac ur ng area: , f t i 4 000 sm

• Manufacturing equipment: $9m

• Initial capacity: 40 , 000 patients pa

• Double capacity ~ $10m

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Employee Headcount at September 2009
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	Australia UK USA China Total 86 16 8 1 111

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Financial Statements
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								Year ended 30 June
				2005			2006				2007			2008			2009
	Income Statements		A$'000			A$'000				A$'000			A$'000			A$'000
	R f l f d evenue rom sa e ogoo s		-			8				20 5			2 5 7			9 5 5
	Cost of sales		-			(2)				(49)			(129)			(153)
	Gross profit		-			6				156			398			442
	Other income
	Interest		1,702			4,282				5,278			7,402			5,347
	Other income		1,219			1,299				2,152			1,576			523
	Expenses
	Research & development		(9,269)		(16,978)				(23,840)			(19,996)			(29,308)
	Commercial		(963)		(1,946)				(3,240)			(4,557)			(6,202)
	Administration		(3,134)		(4,391)				(4,666)			(5,231)			(5,800)
	Finance		-		-				-			-			(122)
	Total expenses		(13 366) ,		(23 315) ,				(31 746) ,			(29 784) ,			(41 432) ,
	Net loss before tax		(10,445)		(17,728)				(24,160)			(20,408)			(35,120)
	Income tax expense		-		(5)				(19)			(32)			(51)
	Net loss after tax		(10,445)		(17,733)				(24,179)			(20,440)			(35,171)
	Earnings (loss) per share $ -		(0 084) .		(0 111) .				(0 136) .			(0 108) .			(0 180) .
	Depreciation & amortisation		646		947				939			1,024			1,265
	Fair value of employe options issued		260		1,488				1,488			3,434			2,432

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Financial Statements
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																		30-Jun-09 A$'000 124,993 32,698 163,997 (26,306) 245,958 137 691 , '000 217,659 15 075 ,	30-Jun-09 A$'000 124,993 32,698 163,997 (26,306) 245,958 137 691 , '000 217,659 15 075 ,	30-Jun-09 A$'000 124,993 32,698 163,997 (26,306) 245,958 137 691 , '000 217,659 15 075 ,
												As at
			30-Jun-05				30-Jun-06				30-Jun-07			30-Jun-08				30-Jun-09
	Balance Sheets			A$'000				A$'000				A$'000			A$'000				A$'000
	Cash and cash equivalents				33,390			97,840				76,182		111,842				124,993
	Plant & equipment				2,477			3,205				3,521		3,668				32,698
	Total assets				37,937			104,267				82,648		125,049				163,997
	Total liabilities				(2,470)			(5,379)				(6,089)		(5,928)				(26,306)
	Contributed equity				54,716		134,745				135,108			194,680				245,958
	Total shareholders' equity				35 467 ,				98 888 ,		76 559 ,			119 121 ,				137 691 ,
	Share Data				'000				'000			'000				'000				'000
	Ordinary shares on issue			134,770			176,904				177,949			194,515				217,659
	O ti t t di p ons ou s an ng			10 914 ,			9 692 ,				9 836 ,			11 536 ,				15 075 ,

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Share Capital
(including options)
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Management – 6%

Other/retail – 33%

Institutions – 61% (68 hold over 100k shares)

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30 September 2009: 217.9m shares; 14.7m options

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END

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