vaccines: india’s strength

For more information be invited to: www.intercell.com

VACCINES: India’s Strength

BIOASIA 2009 FEBRUARY 3, 2009MARTIN GOETTING VP MARKETING, SALES AND SUPPLY

FEBRUARY 3, 2009BIO ASIA 2009PAGE 2

Safe Harbour StatementThese materials are not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the “Securities Act”). The shares of Intercell AG (the “Company”) have not been and will not be registered under the Securities Act and will be offered and sold in the United States only to qualified institutional buyers in reliance on Rule 144A and outside the United States in reliance on Regulation S. You should not base your decision to invest in the Company’s shares on these materials. Any decision to invest in the Company’s shares should be based solely on the information contained in the offering document (the “Offering Document”) that will be prepared in connection with the offer and sale of the Company’s shares referred to herein (the “Offering”). The Offering will be made only to qualifying investors by means of the Offering Document. These materials are strictly confidential and must not be disclosed or distributed to third parties.During the course of this presentation, the Company may make projections or other forward-looking statements regarding, among other things, the progress, timing and completion of our research, development and clinical trials for product candidates, the Company’s ability to market, commercialize and achieve market acceptance for product candidates, its ability to protect its intellectual property and operate its business without infringing on the intellectual property rights of others, the Company’s estimates for future performance and its estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing. In addition, even if the Company’s actual results or development are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of the company’s results or developments in the future. In some cases, you can identify these forward looking statements by words such as “could,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” or similar words. These forward-looking statements are based largely on the Company’s current expectations as of the date of this presentation and are subject to a number of known and unknown risks and uncertainties and other factors that may cause its actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Except as otherwise required by applicable securities laws, we disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.These materials are directed only at persons (I) who are outside the United Kingdom or (II) who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the “Order”) or (III) who fall within article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Order (all such persons together being referred to as “Relevant Persons”). Any person who is not a Relevant Person must not act or rely on this communication or any of its contents. Any investment or investment activity to which this communication relates is available only to Relevant Persons and will be engaged in only with Relevant Persons.


Agenda

» Infection and Prophylaxis

» Intercell in a Nutshell

» Japanese Encephalitis

» Vaccination in India

» A European – Indian Partnership


Microbial infections – key threat to human life

» Terminate of every 4th human life

» Three major killers: Malaria, AIDS and Tuberculosis

» Multi-drug resistant microbes

» Novel emerging pathogens

» Bioterrorism

» Pandemic influenza

OVERVIEW

Worldwide approx. 500,000 people killed by the annual flu epidemic

Estimated 50,000,000 people killed by pandemic flu 1918

» 13 million deaths per year in developing countries

Egon Schiele,1890 - 1918


Infectious diseases: a continuous threat for the developed and less developed world

EXAMPLES INFECTIOUS DISEASES

>300m people infected 1.5m deaths per year

Malaria

2bn people latently infected3m deaths per year

Tuberculosis

40m people infected>15m deaths so far

AIDS

i.e. Germany: >40,000 deaths per year, ~10% of all deaths in hospitals

Hospital infections

170m people infected>50,000 deaths per year

Hepatitis C


0

5

10

15

20

1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 19950

5

10

15

20

25

30

Drastic decrease of HIB Meningitis after introduction of new vaccine in US

Vaccine dosesin m

Casesper 100,000

VACCINES WORK


Agenda







People:

» Key Management: G. Zettlmeissl (CEO), A. v. Gabain (CSO and co-founder), T. Lingelbach (COO) & W. Lanthaler (CFO)

» Supervisory board: M. Gréco, E.G. Afting, S. Bakali, D. Ebsworth, J. Sulat,H. Wigzell

» SAB: R. Ahmed, H. Blum, S. Cohen, F.X. Heinz,S. Kaufmann, S. Normark, H. Wigzell

History:

Spin off from the Campus Vienna Biocenter, IMP and University 1998Today ca. 350 employees from 16 nations in Vienna, Austria, Livingston UK and Gaithersburg, USA

Partners:

Novartis, Merck (USA), Sanofi Aventis, Wyeth, Kirin, SSI, Biological E, EC, NIH, CDC, WRAIR, AERAS foundation, Karolinska, MPI, GBF and many academic organizations

Products:

Therapeutic & prophylactic vaccines and antibody treatments based on cutting edge R&D

Funding: 3 private VC rounds,

since 2005 listed at the ATX (ICLL): today’s Market cap: ca. $ 1.5 Bill

Celebrating 10 years continuous success

INTERCELL IN A NUTSHELL


Vaccine innovation

OUR VALUE PROPOSITION

IC31® New vaccine adjuvants

AIP® Technology generating novel vaccine and antibody products

Vaccine patchTechnology for vaccine delivery with patch

New global travelers' vaccines» Japanese Encephalitis vaccine – expected market

approval US/EU/AUS 2008, India 2009Market potential: EUR 250m – 350m

» Travelers' Diarrhea vaccine patch – expected start of Phase III early 2009Market potential: > EUR 0.5bn

Hospital-acquired infections (vaccines & antibodies)» Leading approach for vaccines & antibodies

S. aureus vaccine – in Phase IIMarket potential: > EUR 3bn

Pseudomonas vaccine – expected start of Phase II/III in 2008Market potential: > EUR 1bn

* Strategic Partnerships

ProductsTechnologies

Leading products for» Therapeutic Hepatitis C vaccine – in Phase II» Patch / Pandemic Flu vaccine – in Phase I/II» IC31® / Seasonal Flu vaccine – in Phase I/II» Protein-based Pneumococcus vaccine – expected start

of Phase I in 2009» IC31® / TB vaccine – in Phase I/IIMarket potential: > EUR 0.5-3bn per target

Innovative biotech

company for vaccines, antibodies

and delivery technology


Significant areas of unmet medical need

» Cholera» Diphtheria» H. influenza B» Hepatitis A» Hepatitis B» Influenza» Japanese Encephalitis» Measles» Meningitis C» Mumps» Papilloma» Pertussis» Pneumococcus» Polio» Rota» Rubella» Tetanus» Tick Borne Encephalitis» Typhus» Varicella

?

» Borrelia» Candida » Chlamydia» Cytomegalovirus» Dengue» Enterococcus» Group A Strep.» Group B Strep.» Hepatitis C» Herpes» HIV» Klebsiella» Legionella» Meningitis B» Mycoplasma» Otits Media» Plasmodium» Pseudomonas

» Rickettsia» SARS» Shigella» Staphylococcus» Toxoplasma» Treponema» Tuberculosis

(in adults)

VACCINES ON THE MARKET NO EFFECTIVE VACCINES AGAINST


Agenda







Late stage products for Japanese Encephalitis and Travelers’ Diarrhea

* Focused on ETEC strain – the cause of 40-50% of all TD cases

» Creation of a travelers' vaccine franchise Expands travelers'

vaccine offering Similar regional

target markets and end users (travelers and military)

Limited competing programs

» Combined Market Opportunity > EUR 750m

» Potential for first approved TD vaccine*

» Positive Phase II efficacy data for TD needle-free vaccine patch – expected start of Phase III early 2009

» Leading global JEV franchise

» Filed - expected market approval in US/EU/AUS in 2009 and India in 2010

» No competing product expected in near future

JAPANESE ENCEPHALITIS

» 30,000-50,000 cases p.a.

» 25% fatality rate

» ~28m travelers to endemic areas p.a.

TRAVELERS' DIARRHEA

» 15-20m cases p.a.

» Most significant source of morbidity for travelers

» ~55m travelers to high risk areas p.a.

Market Opportunity ~ EUR 500m

LEADING TRAVELERS' VACCINE FRANCHISE

Market Opportunity ~ EUR 250–350m


A straight forward procedure for skin delivery of vaccines with simple devices

SKIN PRETREATMENT AND VACCINE PATCH


Needle-free vaccination – a new paradigm

VACCINE PATCH TECHNOLOGY – IC-VEP*

Vaccine Delivery via a patch

Immune Response

Migration

APCs*

Ep

ider

mis

Draining Lymph Node

Activated APCs

Der

mis

Vaccine+/-

Adjuvant

Va

cc

ine

pa

tch

TCI technology allows large proteins to move through skin into lymphatic system V

acci

ne

En

han

cem

ent

Bet

ter

Del

iver

y

Potential applications Partner

HHS

Travelers’ DiarrheaPatch (Phase II)

In-house

In-house

In-house

Pneumococcus patch

Many others Also interesting because of thermo stability!

Pandemic Flu(Phase I/II)

One time application JEV patch

Reduction of injections for children

In-house

In-house, partnered* Vaccine

Enhancement Patch


Japanese Encephalitis – high unmet medical needs

Military deployed to endemic areas

Expatriates in rural areas

Travelers

Key risk groups

» 50,000 cases and 10,000 deaths reported annually worldwide» 1 in 200 infections results in severe disease - fatality 60%; 30% of the survivors suffer

from lasting damage to the central nervous system. » Annual incidence 1- 10 cases per 10,000 in endemic populations (3 billion people)» Non-local population incidence similar to non-immunized residents

Residents of rural areas in endemic locations


DEVELOPMENT AND REGULATORY PATHWAY

2005 2006 2008/2009

» Production of Phase III material

» Pivotal Phase III clinical trials started in September 2005

» Distribution partnerships Australia (CSL) India, Nepal, Bhutan

and Pakistan (Biological E.)

» Interim safety data

» Decision on orphan drug status in EU

» End of recruitment for pivotal Phase III clinical trial

» Phase III clinical efficacy data (mid-06)

» Distribution partnership for US & EU travelers' markets (Novartis)

» Phase III safety data

» Initiation of regulatory filing with FDA under IND

» Build up commercial manufacturing and supply chain

» Completion of regulatory filing processes

» Pediatric data from endemic countries

» FDA inspection of facility» Build up commercialization

to military markets» Partnership for Japanese

and Korean market» Market approval US

filed» Market approval EU

filed» Market approval AUS

» Market approval India

Execution on "JEV to All Markets"


50

55

60

65

70

75

80

85

90

95

100

IC51**(n = 365)Adults

Old Vaccine(n = 370)

Day 56

50

70

90

110

130

150

170

190

210

230

250

Number of vaccinations 2 3

Our product:» Attenuated strain,

inactivated» Virus propagation

using Vero cells» No stabilizers, no

preservatives» Excellent safety

profile» More potent» More persistent» More convenient

Excellent results in adults and children*

Seroconversion (protective antibodies)

* Total number of subjects in Phase III studies about 4,000Safety: 2,012 subjects versus 663 placebo

** 6 mcg/dose (=adult dose)

*** 3 mcg/dose(=half adult dose)

Geometric Mean Titers

Day 56

IC51**(n = 365)Adults

Old Vaccine(n = 370)

2 3

Non-inferiority baseline

IC51 / JESPECT

2 2

IC51***(n = 60)Children

IC51***(n = 60)Children

%


Population

First Clinical trial in Children with IC51

» 60 healthy children ≥1 to <3 years of age

» 1 site in India (Bangalore)

PEDIATRIC PHASE 2 DOSE CONFIRMATION STUDY

R

Safety GMT Day 56

IXIARO 0.5 ml, days 0/28, im 24 subjects

IXIARO 0.25 ml, days 0/28, im 24 subjects

JenceVacTM 0.5 ml, days 0/7/28, sc 12 subjects

TRIAL IC51-221


4,3 4,80,0

65,271,4

63,6

95,7 95,290,9

IC51 - 0.25mL IC51 - 0.5mL JenceVac 0.5mL

Excellent Immunogenicity Results for both Dosages with IC51

IMMUNOGENICITY RESULTS Screening

Day 28

Day 56

Seroconversion Rates (%) at Screening, Day 28 and Day 56

N=23 N=21 N=11

GMT at Day 56 200.9 218.1 230.3

TRIAL IC51-221


No Serious Adverse Events were reported, all Adverse Events were mild in nature

SAFETY OF IC51 IN CHILDREN

* p-value = 0.2850 – no significant differences between all groups

IC51Half adult

doseN=24n (%)

IC51Adult dose

N=24n (%)

JenceVacTM

N=12n (%)

AllN=60n (%)

Number of AEFIs(% against total events)

3 (23.1) 5 (38.5) 5 (38.5) 13 (100)

Number of Subjects with at least one AEFI

3 (12.5) 5 (20.8) 4 (33.3) 12 (20.0)*

» Fever 0 (0.0) 1 (4.2) 1 (8.3) 2 (3.3)» Injection Site

Tenderness2 (8.2) 3 (12.5) 3 (25.0) 8 (13.3)

» Skin Lesion 1 (4.2) 0 (0.0) 0 (0.0) 1 (1.7)» Skin Rash 0 (0.0) 1 (4.2) 0 (0.0) 1 (1.7)

Adverse Events Following Immunization (AEFIs)

TRIAL DESIGNATED AS IC51-221


Intercell partners worldwide

CSL

» Australia» New Zealand» Papua New Guinea

Intercell» US Military Market

for 3 years

Biological E» India» Nepal» Pakistan» Bhutan

Novartis

» US» Europe» Canada» Japan» Korea

IC 51

IC 51 IC 51

IC 51

IC 51

JESPECT

IC 52

IC 52

Biological E production


Agenda







Nearly 120 years of History in Vaccines

» History goes back to British rulers concerned about the health of their personnel

» Establishment of about fifteen institutes beginning in the 1890s» Development of the world’s first plague vaccine in 1987 in Mumbai by

Haffkine

BRIEF HISTORY OF VACCINES & VACCINATION IN INDIA

* Shanta Biotech

Source: “Vaccine Policy in India”, Yennapu Madhavi, 2005

Vaccine

Year of Introduction

India Elsewhere

Smallpox 1898 1890s

Plague 1897 1897

Cholera 1892 1892

TT,DT,DPT 1920s 1920s

OPV 1967 1962

Hep B 1997* 1980s


WHO reporting shows Japanese Encephalitis Rank 4 – high underreporting

70,729

36,900

7,005

4,017

3,354

937

873

0

0

0

Pertussis

Measles

Tetanus (total)

Japanese encephalitis

Diphtheria

NEED FOR VACCINES IN INDIA

Source: WHO webpage

Number of reported cases in 2007

Tetanus (neonatal)

Polio*

Mumps

Rubella

Rubella (CRS)

» Approx. 1,15 billion inhabitants

» Approx. 27 million birth p.a.


Positive Climate and Basis for Vaccination

Children*:» Live Birth: 27 million» Children less than 5 years: 126 million» 62% children receive DTP3 & OPV3

Parents:» Increasing Purchasing Capacity» Increasing acceptance to new Vaccines

Manufacturers:» Large Production Capabilities» WHO pre-qualified Facilities» Cost efficiency in Manufacturing.

VACCINATION IN INDIA TODAY

*WHO Data 16th Dec. 08


Indian Vaccine Market - Product Mix

*WHO Data 16th Dec. 08

EPI (Govt) Private Sector

1. BCG2. OPV3. DTPw4. DT5. TT6. Measles7. Hepatitis B8. JE (part of country)9. Hib (Q2 ‘09 onwards)

1. Rabies 2. Chickenpox3. Hepatitis A4. Hib based combinations5. IPV based combinations6. aP based combinations7. Flu 8. Meningococcal9. Pneumococcal 10. HPV


Vaccine Market in India

Total Vaccine Market – Rs. 10 billion (app. 205 million USD)» Private Market – Rs. 2.2 billion*» Institution/ EPI Market – Rs. 7.8 billion

Market Growth – 25 to 30%*

Top Vaccine Manufacturers*1. Serum Institute2. Panacea Biotec3. Biological E Ltd.4. Shanta Biotechnics5. Bharat Biotech

VACCINATION IN INDIA TODAY

*Data as per ORG IMS (MAT Nov 08)


Agenda







A history of collaboration with the best

» Originally incorporated as Biological Products Private Limited in 1953

» Partnership with Evans Medical of UK to develop pharmaceutical formulations

» Collaboration with Glaxo to focus on building the pharmaceutical business in India.

» Collaboration with Pasteur Merieux Connaught, France, and Solvay, Belgium.

» Every tie-up has sought to strengthen and advance Innovation, Expansion and Development of product lines

BIOLOGICAL E, HYDERABAD


Intercell’s Partner in India

•Biological E is India’s first private bio-pharma company, established 1953.•Expert in development & manufacture of vaccines & biologics•Innovative, strategic partnerships for worldwide development, commercialization

- Intercell, Austria – JE - NVI, Netherlands – Hib & IPV- Itero Biopharma, USA – multiple products

•Over 2 Billion doses of DTwP, DT & TT have been supplied to the Govt. of India.


Aim to become a major world player in vaccines

BIOLOGICAL E, HYDERABAD

» Market leader in the Tetanus Toxoid segment in India

» Production of a new generation of vaccines in order to also reach out to international markets

» Manufacturing facilities have been awarded with the WHO GMP certification

» The new facilities at Biotech Park Phase II, Andhra Pradesh are aimed at acquiring WHO prequalification for all the products.

» Sales offices at 23 locations and 25 depots

» Dedicated, growing vaccines sales force


Tailored Agreement Platform for a successful Collaboration

» Manufacturing Technology Transfer

INTERCELL’S COLLABORATION WITH BIOLOGICAL E

» Co-Development

» Commercialization

Three Agreements were signed in 2005


Biological E - Intercell’s Partner in India

BioE’s state-of-art manufacturing facility

commissioned at Shameerpet, Hyderabad

Intercell AG, Austria:

- BioE has exclusive manufacturing rights

for JE endemic regions

- Marketing rights for India, Pakistan,

Nepal and Bhutan


Biological E – following successful process locking consistency manufacturing will commence

ROADMAP

» Tech Transfer Analytical Methods

transfer Trial Runs

Consistency Runs

NRA Testing & Release

Q1 Q2Q3 Q4

» Phase III Clinical Trials Protocol Clinical Trial

Q220102008 2009

Q1 Q2Q3 Q4

» Licensure India

» WHO Pre-qualification WHO Pre-

qualifcation

Q3 Q4

80RB

Fill

Fill180RB

180RB

Licensure

180RB

Fill

Fill

Fill

Fill

Fill

1yr

Bulk Formulation

Bulk QC incl. potency

Final container QC incl. potency


Vaccines: India’s Strength

CONCLUSIONS

» India has a long and rich history in vaccination

» Strong need for high quality vaccines for an affordable price

» India has a strong and fast growing vaccines industry

» The Indian vaccine companies conclude win-win partnerships with vaccine players from all over the world

» India, the world’s pharmacy….

……India, the world’s vaccine manufacturer?

FEBRUARY 3, 2009BIO ASIA 2009PAGE 36 For more information be invited to: www.intercell.com


Vaccination in India today

» In 1948 India became member country of the WHO» Establishment of new Indian health care institutions» First official policy for childhood vaccination in 1978

* Part of country

Immunization schedule (2007 or latest available)

Vaccine Schedule

BCG birth

DT 5 years

DTwP 6, 10, 14 weeks; 16-24 months

HepB* 6, 10, 14 weeks

JapEnc* 1-2 years

Measles 9-12 months;

OPV birth; 6, 10, 14 weeks; 16-24 months

TT 10, 16 years (0 & 16 Y Preg. Women)


BIOLOGICAL E, HYDERABAD – PHARMACEUTICALS

Pharmaceutical Business from Development to Distribution

» From 1977 Biological E Limited has focused on building its pharmaceutical business in India.

» Core competencies are development, manufacturing and marketing of pharmaceuticals.

» Dedicated manufacturing facilities for Solid Dosage Forms, Liquid Orals and Syrups, Parenterals and Active Pharmaceutical Ingredients

» Continuous investment in world-class facilities that will be in accordance with US FDA and EMEA standards

» Sales offices at 23 locations and 25 depots. We cover around 1,00,000 doctors allover India and our products are sold by around 15,000 stockists in India

vaccines: india’s strength

Health & Medicine