VACCINES: India’s Strength

VACCINES: India’s Strength B IO A SIA 2009 FEBRUARY 3, 2009 MARTIN GOETTING VP MARKETING, SALES AND SUPPLY

Safe Harbour Statement ,[object Object],[object Object],[object Object],FEBRUARY 3, 2009 BIO ASIA 2009 PAGE

Agenda FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],[object Object],[object Object]

Microbial infections – key threat to human life FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],OVERVIEW Worldwide approx. 500,000 people killed by the annual flu epidemic Estimated 50,000,000 people killed by pandemic flu 1918 ,[object Object],Egon Schiele, 1890 - 1918

Infectious diseases: a continuous threat for the developed and less developed world FEBRUARY 3, 2009 BIO ASIA 2009 PAGE EXAMPLES INFECTIOUS DISEASES >300m people infected 1.5m deaths per year Malaria 2bn people latently infected 3m 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

Drastic decrease of HIB Meningitis after introduction of new vaccine in US FEBRUARY 3, 2009 BIO ASIA 2009 PAGE Vaccine doses in m Cases per 100,000 VACCINES WORK

FEBRUARY 3, 2009 BIO ASIA 2009 PAGE 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 Celebrating 10 years continuous success INTERCELL IN A NUTSHELL History: Spin off from the Campus Vienna Biocenter, IMP and University 1998 Today 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

Vaccine innovation FEBRUARY 3, 2009 BIO ASIA 2009 PAGE OUR VALUE PROPOSITION IC31 ® New vaccine adjuvants AIP ® Technology generating novel vaccine and antibody products Vaccine patch Technology for vaccine delivery with patch ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],* Strategic Partnerships Products Technologies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Innovative biotech company for vaccines, antibodies and delivery technology

Significant areas of unmet medical need FEBRUARY 3, 2009 BIO ASIA 2009 PAGE  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],VACCINES ON THE MARKET NO EFFECTIVE VACCINES AGAINST

Late stage products for Japanese Encephalitis and Travelers’ Diarrhea FEBRUARY 3, 2009 BIO ASIA 2009 PAGE * Focused on ETEC strain – the cause of 40-50% of all TD cases ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],JAPANESE ENCEPHALITIS ,[object Object],[object Object],[object Object],TRAVELERS' DIARRHEA ,[object Object],[object Object],[object Object],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 FEBRUARY 3, 2009 BIO ASIA 2009 PAGE SKIN PRETREATMENT AND VACCINE PATCH

Needle-free vaccination – a new paradigm FEBRUARY 3, 2009 BIO ASIA 2009 PAGE VACCINE PATCH TECHNOLOGY – IC-VEP* Vaccine Delivery via a patch Immune Response Migration APCs* Epidermis Draining Lymph Node Activated APCs Dermis Vaccine +/- Adjuvant Vaccine patch TCI technology allows large proteins to move through skin into lymphatic system Vaccine Enhancement Better Delivery Potential applications Partner HHS Travelers’ Diarrhea Patch (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 * V accine E nhancement P atch

Japanese Encephalitis – high unmet medical needs FEBRUARY 3, 2009 BIO ASIA 2009 PAGE Military deployed to endemic areas Expatriates in rural areas Travelers Key risk groups ,[object Object],[object Object],[object Object],[object Object],Residents of rural areas in endemic locations

FEBRUARY 3, 2009 BIO ASIA 2009 PAGE DEVELOPMENT AND REGULATORY PATHWAY 2005 2006 2008/2009 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],            Execution on "JEV to All Markets"     

Excellent results in adults and children* FEBRUARY 3, 2009 BIO ASIA 2009 PAGE IC51** (n = 365) Adults Old Vaccine (n = 370) Day 56 Number of vaccinations 2 3 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Seroconversion (protective antibodies) * Total number of subjects in Phase III studies about 4,000 Safety: 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 %

First Clinical trial in Children with IC51 FEBRUARY 3, 2009 BIO ASIA 2009 PAGE Population ,[object Object],[object Object],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 JenceVac TM 0.5 ml, days 0/7/28, sc 12 subjects TRIAL IC51-221

Excellent Immunogenicity Results for both Dosages with IC51 FEBRUARY 3, 2009 BIO ASIA 2009 PAGE IMMUNOGENICITY RESULTS Screening Day 28 Day 56 Seroconversion Rates (%) at Screening, Day 28 and Day 56 TRIAL IC51-221 N=23 N=21 N=11 GMT at Day 56 200.9 218.1 230.3

No Serious Adverse Events were reported, all Adverse Events were mild in nature FEBRUARY 3, 2009 BIO ASIA 2009 PAGE SAFETY OF IC51 IN CHILDREN * p-value = 0.2850 – no significant differences between all groups ,[object Object],TRIAL DESIGNATED AS IC51-221 IC51 Half adult dose N=24 n (%) IC51 Adult dose N=24 n (%) JenceVac TM N=12 n (%) All N=60 n (%) 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)* ,[object Object],0 (0.0) 1 (4.2) 1 (8.3) 2 (3.3) ,[object Object],2 (8.2) 3 (12.5) 3 (25.0) 8 (13.3) ,[object Object],1 (4.2) 0 (0.0) 0 (0.0) 1 (1.7) ,[object Object],0 (0.0) 1 (4.2) 0 (0.0) 1 (1.7)

Intercell partners worldwide FEBRUARY 3, 2009 BIO ASIA 2009 PAGE CSL ,[object Object],[object Object],[object Object],Intercell ,[object Object],Biological E ,[object Object],[object Object],[object Object],[object Object],Novartis ,[object Object],[object Object],[object Object],[object Object],[object Object],IC 51 IC 51 IC 51 IC 51 IC 51 JESPECT IC 52 IC 52 Biological E production

Nearly 120 years of History in Vaccines FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],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 FEBRUARY 3, 2009 BIO ASIA 2009 PAGE 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) ,[object Object],[object Object]

Positive Climate and Basis for Vaccination FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],VACCINATION IN INDIA TODAY *WHO Data 16th Dec. 08

Indian Vaccine Market - Product Mix FEBRUARY 3, 2009 BIO ASIA 2009 PAGE *WHO Data 16th Dec. 08 EPI (Govt) Private Sector ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Vaccine Market in India FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],VACCINATION IN INDIA TODAY *Data as per ORG IMS (MAT Nov 08)

A history of collaboration with the best FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],[object Object],[object Object],BIOLOGICAL E, HYDERABAD

Intercell’s Partner in India FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Aim to become a major world player in vaccines FEBRUARY 3, 2009 BIO ASIA 2009 PAGE BIOLOGICAL E, HYDERABAD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Tailored Agreement Platform for a successful Collaboration FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],INTERCELL’S COLLABORATION WITH BIOLOGICAL E ,[object Object],[object Object],[object Object]

Biological E - Intercell’s Partner in India FEBRUARY 3, 2009 BIO ASIA 2009 PAGE 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 FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ROADMAP Bulk Formulation Bulk QC incl. potency Final container QC incl. potency ,[object Object],[object Object],[object Object],[object Object],[object Object],Q1 Q2 Q3 Q4 ,[object Object],[object Object],[object Object],Q2 2010 2008 2009 Q1 Q2 Q3 Q4 ,[object Object],[object Object],[object Object],WHO Pre-qualifcation Q3 Q4 80RB Fill Fill 180RB 180RB Licensure 180RB Fill Fill Fill Fill Fill 1yr

Vaccines: India’s Strength FEBRUARY 3, 2009 BIO ASIA 2009 PAGE CONCLUSIONS ,[object Object],[object Object],[object Object],[object Object],[object Object]

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

Vaccination in India today FEBRUARY 3, 2009 BIO ASIA 2009 PAGE ,[object Object],[object Object],[object Object],* 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)

Pharmaceutical Business from Development to Distribution FEBRUARY 3, 2009 BIO ASIA 2009 PAGE BIOLOGICAL E, HYDERABAD – PHARMACEUTICALS ,[object Object],[object Object],[object Object],[object Object],[object Object]

VACCINES: India’s Strength

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VACCINES: India’s Strength

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