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VACCINES: India’s Strength


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VACCINES: India’s Strength

  2. 2. Safe Harbour Statement <ul><li>These 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. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>FEBRUARY 3, 2009 BIO ASIA 2009 PAGE
  3. 3. Agenda FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Infection and Prophylaxis </li></ul></ul><ul><ul><li>Intercell in a Nutshell </li></ul></ul><ul><ul><li>Japanese Encephalitis </li></ul></ul><ul><ul><li>Vaccination in India </li></ul></ul><ul><ul><li>A European – Indian Partnership </li></ul></ul>
  4. 4. Microbial infections – key threat to human life FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Terminate of every 4 th human life </li></ul></ul><ul><ul><li>Three major killers: Malaria, AIDS and Tuberculosis </li></ul></ul><ul><ul><li>Multi-drug resistant microbes </li></ul></ul><ul><ul><li>Novel emerging pathogens </li></ul></ul><ul><ul><li>Bioterrorism </li></ul></ul><ul><ul><li>Pandemic influenza </li></ul></ul>OVERVIEW Worldwide approx. 500,000 people killed by the annual flu epidemic Estimated 50,000,000 people killed by pandemic flu 1918 <ul><ul><li>13 million deaths per year in developing countries </li></ul></ul>Egon Schiele, 1890 - 1918
  5. 5. 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
  6. 6. 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
  7. 7. Agenda FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Infection and Prophylaxis </li></ul></ul><ul><ul><li>Intercell in a Nutshell </li></ul></ul><ul><ul><li>Japanese Encephalitis </li></ul></ul><ul><ul><li>Vaccination in India </li></ul></ul><ul><ul><li>A European – Indian Partnership </li></ul></ul>
  8. 8. 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
  9. 9. 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 <ul><li>New global travelers' vaccines </li></ul><ul><ul><li>Japanese Encephalitis vaccine – expected market approval US/EU/AUS 2008, India 2009 Market potential: EUR 250m – 350m </li></ul></ul><ul><ul><li>Travelers' Diarrhea vaccine patch – expected start of Phase III early 2009 Market potential: > EUR 0.5bn </li></ul></ul><ul><li>Hospital-acquired infections (vaccines & antibodies) </li></ul><ul><ul><li>Leading approach for vaccines & antibodies </li></ul></ul><ul><ul><ul><li>S. aureus vaccine – in Phase II Market potential: > EUR 3bn </li></ul></ul></ul><ul><ul><ul><li>Pseudomonas vaccine – expected start of Phase II/III in 2008 Market potential: > EUR 1bn </li></ul></ul></ul>* Strategic Partnerships Products Technologies <ul><li>Leading products for </li></ul><ul><ul><li>Therapeutic Hepatitis C vaccine – in Phase II </li></ul></ul><ul><ul><li>Patch / Pandemic Flu vaccine – in Phase I/II </li></ul></ul><ul><ul><li>IC31 ® / Seasonal Flu vaccine – in Phase I/II </li></ul></ul><ul><ul><li>Protein-based Pneumococcus vaccine – expected start of Phase I in 2009 </li></ul></ul><ul><ul><li>IC31 ® / TB vaccine – in Phase I/II </li></ul></ul><ul><ul><li>Market potential: > EUR 0.5-3bn per target </li></ul></ul>Innovative biotech company for vaccines, antibodies and delivery technology
  10. 10. Significant areas of unmet medical need FEBRUARY 3, 2009 BIO ASIA 2009 PAGE  <ul><ul><li>Cholera </li></ul></ul><ul><ul><li>Diphtheria </li></ul></ul><ul><ul><li>H. influenza B </li></ul></ul><ul><ul><li>Hepatitis A </li></ul></ul><ul><ul><li>Hepatitis B </li></ul></ul><ul><ul><li>Influenza </li></ul></ul><ul><ul><li>Japanese Encephalitis </li></ul></ul><ul><ul><li>Measles </li></ul></ul><ul><ul><li>Meningitis C </li></ul></ul><ul><ul><li>Mumps </li></ul></ul><ul><ul><li>Papilloma </li></ul></ul><ul><ul><li>Pertussis </li></ul></ul><ul><ul><li>Pneumococcus </li></ul></ul><ul><ul><li>Polio </li></ul></ul><ul><ul><li>Rota </li></ul></ul><ul><ul><li>Rubella </li></ul></ul><ul><ul><li>Tetanus </li></ul></ul><ul><ul><li>Tick Borne Encephalitis </li></ul></ul><ul><ul><li>Typhus </li></ul></ul><ul><ul><li>Varicella </li></ul></ul>? <ul><ul><li>Borrelia </li></ul></ul><ul><ul><li>Candida </li></ul></ul><ul><ul><li>Chlamydia </li></ul></ul><ul><ul><li>Cytomegalovirus </li></ul></ul><ul><ul><li>Dengue </li></ul></ul><ul><ul><li>Enterococcus </li></ul></ul><ul><ul><li>Group A Strep. </li></ul></ul><ul><ul><li>Group B Strep. </li></ul></ul><ul><ul><li>Hepatitis C </li></ul></ul><ul><ul><li>Herpes </li></ul></ul><ul><ul><li>HIV </li></ul></ul><ul><ul><li>Klebsiella </li></ul></ul><ul><ul><li>Legionella </li></ul></ul><ul><ul><li>Meningitis B </li></ul></ul><ul><ul><li>Mycoplasma </li></ul></ul><ul><ul><li>Otits Media </li></ul></ul><ul><ul><li>Plasmodium </li></ul></ul><ul><ul><li>Pseudomonas </li></ul></ul><ul><ul><li>Rickettsia </li></ul></ul><ul><ul><li>SARS </li></ul></ul><ul><ul><li>Shigella </li></ul></ul><ul><ul><li>Staphylococcus </li></ul></ul><ul><ul><li>Toxoplasma </li></ul></ul><ul><ul><li>Treponema </li></ul></ul><ul><ul><li>Tuberculosis (in adults) </li></ul></ul>VACCINES ON THE MARKET NO EFFECTIVE VACCINES AGAINST
  11. 11. Agenda FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Infection and Prophylaxis </li></ul></ul><ul><ul><li>Intercell in a Nutshell </li></ul></ul><ul><ul><li>Japanese Encephalitis </li></ul></ul><ul><ul><li>Vaccination in India </li></ul></ul><ul><ul><li>A European – Indian Partnership </li></ul></ul>
  12. 12. 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 <ul><ul><li>Creation of a travelers' vaccine franchise </li></ul></ul><ul><ul><ul><li>Expands travelers' vaccine offering </li></ul></ul></ul><ul><ul><ul><li>Similar regional target markets and end users (travelers and military) </li></ul></ul></ul><ul><ul><ul><li>Limited competing programs </li></ul></ul></ul><ul><ul><li>Combined Market Opportunity > EUR 750m </li></ul></ul><ul><ul><li>Potential for first approved TD vaccine* </li></ul></ul><ul><ul><li>Positive Phase II efficacy data for TD needle-free vaccine patch – expected start of Phase III early 2009 </li></ul></ul><ul><ul><li>Leading global JEV franchise </li></ul></ul><ul><ul><li>Filed - expected market approval in US/EU/AUS in 2009 and India in 2010 </li></ul></ul><ul><ul><li>No competing product expected in near future </li></ul></ul>JAPANESE ENCEPHALITIS <ul><ul><li>30,000-50,000 cases p.a. </li></ul></ul><ul><ul><li>25% fatality rate </li></ul></ul><ul><ul><li>~28m travelers to endemic areas p.a. </li></ul></ul>TRAVELERS' DIARRHEA <ul><ul><li>15-20m cases p.a. </li></ul></ul><ul><ul><li>Most significant source of morbidity for travelers </li></ul></ul><ul><ul><li>~55m travelers to high risk areas p.a. </li></ul></ul>Market Opportunity ~ EUR 500m LEADING TRAVELERS' VACCINE FRANCHISE Market Opportunity ~ EUR 250–350m
  13. 13. A straight forward procedure for skin delivery of vaccines with simple devices FEBRUARY 3, 2009 BIO ASIA 2009 PAGE SKIN PRETREATMENT AND VACCINE PATCH
  14. 14. 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
  15. 15. 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 <ul><ul><li>50,000 cases and 10,000 deaths reported annually worldwide </li></ul></ul><ul><ul><li>1 in 200 infections results in severe disease - fatality 60%; 30% of the survivors suffer from lasting damage to the central nervous system. </li></ul></ul><ul><ul><li>Annual incidence 1- 10 cases per 10,000 in endemic populations (3 billion people) </li></ul></ul><ul><ul><li>Non-local population incidence similar to non-immunized residents </li></ul></ul>Residents of rural areas in endemic locations
  16. 16. FEBRUARY 3, 2009 BIO ASIA 2009 PAGE DEVELOPMENT AND REGULATORY PATHWAY 2005 2006 2008/2009 <ul><ul><li>Production of Phase III material </li></ul></ul><ul><ul><li>Pivotal Phase III clinical trials started in September 2005 </li></ul></ul><ul><ul><li>Distribution partnerships </li></ul></ul><ul><ul><ul><li>Australia (CSL) </li></ul></ul></ul><ul><ul><ul><li>India, Nepal, Bhutan and Pakistan (Biological E.) </li></ul></ul></ul><ul><ul><li>Interim safety data </li></ul></ul><ul><ul><li>Decision on orphan drug status in EU </li></ul></ul><ul><ul><li>End of recruitment for pivotal Phase III clinical trial </li></ul></ul><ul><ul><li>Phase III clinical efficacy data (mid-06) </li></ul></ul><ul><ul><li>Distribution partnership for US & EU travelers' markets (Novartis) </li></ul></ul><ul><ul><li>Phase III safety data </li></ul></ul><ul><ul><li>Initiation of regulatory filing with FDA under IND </li></ul></ul><ul><ul><li>Build up commercial manufacturing and supply chain </li></ul></ul><ul><ul><li>Completion of regulatory filing processes </li></ul></ul><ul><ul><li>Pediatric data from endemic countries </li></ul></ul><ul><ul><li>FDA inspection of facility </li></ul></ul><ul><ul><li>Build up commercialization to military markets </li></ul></ul><ul><ul><li>Partnership for Japanese and Korean market </li></ul></ul><ul><ul><li>Market approval US filed </li></ul></ul><ul><ul><li>Market approval EU filed </li></ul></ul><ul><ul><li>Market approval AUS </li></ul></ul><ul><ul><li>Market approval India </li></ul></ul>            Execution on &quot;JEV to All Markets&quot;     
  17. 17. 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 <ul><li>Our product: </li></ul><ul><ul><li>Attenuated strain, inactivated </li></ul></ul><ul><ul><li>Virus propagation using Vero cells </li></ul></ul><ul><ul><li>No stabilizers, no preservatives </li></ul></ul><ul><ul><li>Excellent safety profile </li></ul></ul><ul><ul><li>More potent </li></ul></ul><ul><ul><li>More persistent </li></ul></ul><ul><ul><li>More convenient </li></ul></ul>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 %
  18. 18. First Clinical trial in Children with IC51 FEBRUARY 3, 2009 BIO ASIA 2009 PAGE Population <ul><ul><li>60 healthy children ≥1 to <3 years of age </li></ul></ul><ul><ul><li>1 site in India (Bangalore) </li></ul></ul>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
  19. 19. 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
  20. 20. 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 <ul><ul><li>Adverse Events Following Immunization (AEFIs) </li></ul></ul>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)* <ul><li>Fever </li></ul>0 (0.0) 1 (4.2) 1 (8.3) 2 (3.3) <ul><li>Injection Site Tenderness </li></ul>2 (8.2) 3 (12.5) 3 (25.0) 8 (13.3) <ul><li>Skin Lesion </li></ul>1 (4.2) 0 (0.0) 0 (0.0) 1 (1.7) <ul><li>Skin Rash </li></ul>0 (0.0) 1 (4.2) 0 (0.0) 1 (1.7)
  21. 21. Intercell partners worldwide FEBRUARY 3, 2009 BIO ASIA 2009 PAGE CSL <ul><ul><li>Australia </li></ul></ul><ul><ul><li>New Zealand </li></ul></ul><ul><ul><li>Papua New Guinea </li></ul></ul>Intercell <ul><ul><li>US Military Market for 3 years </li></ul></ul>Biological E <ul><ul><li>India </li></ul></ul><ul><ul><li>Nepal </li></ul></ul><ul><ul><li>Pakistan </li></ul></ul><ul><ul><li>Bhutan </li></ul></ul>Novartis <ul><ul><li>US </li></ul></ul><ul><ul><li>Europe </li></ul></ul><ul><ul><li>Canada </li></ul></ul><ul><ul><li>Japan </li></ul></ul><ul><ul><li>Korea </li></ul></ul>IC 51 IC 51 IC 51 IC 51 IC 51 JESPECT IC 52 IC 52 Biological E production
  22. 22. Agenda FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Infection and Prophylaxis </li></ul></ul><ul><ul><li>Intercell in a Nutshell </li></ul></ul><ul><ul><li>Japanese Encephalitis </li></ul></ul><ul><ul><li>Vaccination in India </li></ul></ul><ul><ul><li>A European – Indian Partnership </li></ul></ul>
  23. 23. Nearly 120 years of History in Vaccines FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>History goes back to British rulers concerned about the health of their personnel </li></ul></ul><ul><ul><li>Establishment of about fifteen institutes beginning in the 1890s </li></ul></ul><ul><ul><li>Development of the world’s first plague vaccine in 1987 in Mumbai by Haffkine </li></ul></ul>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
  24. 24. 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) <ul><ul><li>Approx. 1,15 billion inhabitants </li></ul></ul><ul><ul><li>Approx. 27 million birth p.a. </li></ul></ul>
  25. 25. Positive Climate and Basis for Vaccination FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><li>Children*: </li></ul><ul><ul><li>Live Birth: 27 million </li></ul></ul><ul><ul><li>Children less than 5 years: 126 million </li></ul></ul><ul><ul><li>62% children receive DTP3 & OPV3 </li></ul></ul><ul><li>Parents: </li></ul><ul><ul><li>Increasing Purchasing Capacity </li></ul></ul><ul><ul><li>Increasing acceptance to new Vaccines </li></ul></ul><ul><li>Manufacturers: </li></ul><ul><ul><li>Large Production Capabilities </li></ul></ul><ul><ul><li>WHO pre-qualified Facilities </li></ul></ul><ul><ul><li>Cost efficiency in Manufacturing. </li></ul></ul>VACCINATION IN INDIA TODAY *WHO Data 16th Dec. 08
  26. 26. Indian Vaccine Market - Product Mix FEBRUARY 3, 2009 BIO ASIA 2009 PAGE *WHO Data 16th Dec. 08 EPI (Govt) Private Sector <ul><li>BCG </li></ul><ul><li>OPV </li></ul><ul><li>DTPw </li></ul><ul><li>DT </li></ul><ul><li>TT </li></ul><ul><li>Measles </li></ul><ul><li>Hepatitis B </li></ul><ul><li>JE (part of country) </li></ul><ul><li>Hib (Q2 ‘09 onwards) </li></ul><ul><li>Rabies </li></ul><ul><li>Chickenpox </li></ul><ul><li>Hepatitis A </li></ul><ul><li>Hib based combinations </li></ul><ul><li>IPV based combinations </li></ul><ul><li>aP based combinations </li></ul><ul><li>Flu </li></ul><ul><li>Meningococcal </li></ul><ul><li>Pneumococcal </li></ul><ul><li>HPV </li></ul>
  27. 27. Vaccine Market in India FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><li>Total Vaccine Market – Rs. 10 billion (app. 205 million USD) </li></ul><ul><ul><li>Private Market – Rs. 2.2 billion* </li></ul></ul><ul><ul><li>Institution/ EPI Market – Rs. 7.8 billion </li></ul></ul><ul><li>Market Growth – 25 to 30%* </li></ul><ul><li>Top Vaccine Manufacturers* </li></ul><ul><ul><li>Serum Institute </li></ul></ul><ul><ul><li>Panacea Biotec </li></ul></ul><ul><ul><li>Biological E Ltd. </li></ul></ul><ul><ul><li>Shanta Biotechnics </li></ul></ul><ul><ul><li>Bharat Biotech </li></ul></ul>VACCINATION IN INDIA TODAY *Data as per ORG IMS (MAT Nov 08)
  28. 28. Agenda FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Infection and Prophylaxis </li></ul></ul><ul><ul><li>Intercell in a Nutshell </li></ul></ul><ul><ul><li>Japanese Encephalitis </li></ul></ul><ul><ul><li>Vaccination in India </li></ul></ul><ul><ul><li>A European – Indian Partnership </li></ul></ul>
  29. 29. A history of collaboration with the best FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Originally incorporated as Biological Products Private Limited in 1953 </li></ul></ul><ul><ul><li>Partnership with Evans Medical of UK to develop pharmaceutical formulations </li></ul></ul><ul><ul><li>Collaboration with Glaxo to focus on building the pharmaceutical business in India. </li></ul></ul><ul><ul><li>Collaboration with Pasteur Merieux Connaught, France, and Solvay, Belgium. </li></ul></ul><ul><ul><li>Every tie-up has sought to strengthen and advance Innovation, Expansion and Development of product lines </li></ul></ul>BIOLOGICAL E, HYDERABAD
  30. 30. Intercell’s Partner in India FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><li>Biological E is India’s first private bio-pharma company, established 1953. </li></ul><ul><li>Expert in development & manufacture of vaccines & biologics </li></ul><ul><li>Innovative, strategic partnerships for worldwide development, commercialization </li></ul><ul><li>- Intercell, Austria – JE </li></ul><ul><li>- NVI, Netherlands – Hib & IPV </li></ul><ul><li>- Itero Biopharma, USA – multiple products </li></ul><ul><li>Over 2 Billion doses of DTwP, DT & TT have been supplied to the Govt. of India. </li></ul>
  31. 31. Aim to become a major world player in vaccines FEBRUARY 3, 2009 BIO ASIA 2009 PAGE BIOLOGICAL E, HYDERABAD <ul><ul><li>Market leader in the Tetanus Toxoid segment in India </li></ul></ul><ul><ul><li>Production of a new generation of vaccines in order to also reach out to international markets </li></ul></ul><ul><ul><li>Manufacturing facilities have been awarded with the WHO GMP certification </li></ul></ul><ul><ul><li>The new facilities at Biotech Park Phase II, Andhra Pradesh are aimed at acquiring WHO prequalification for all the products. </li></ul></ul><ul><ul><li>Sales offices at 23 locations and 25 depots </li></ul></ul><ul><ul><li>Dedicated, growing vaccines sales force </li></ul></ul>
  32. 32. Tailored Agreement Platform for a successful Collaboration FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>Manufacturing Technology Transfer </li></ul></ul>INTERCELL’S COLLABORATION WITH BIOLOGICAL E <ul><ul><li>Co-Development </li></ul></ul><ul><ul><li>Commercialization </li></ul></ul><ul><ul><li>Three Agreements were signed in 2005 </li></ul></ul>
  33. 33. 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
  34. 34. 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 <ul><ul><li>Tech Transfer </li></ul></ul><ul><ul><ul><li>Analytical Methods transfer </li></ul></ul></ul><ul><ul><ul><li>Trial Runs </li></ul></ul></ul><ul><ul><ul><li>Consistency Runs </li></ul></ul></ul><ul><ul><ul><li>NRA Testing & Release </li></ul></ul></ul>Q1 Q2 Q3 Q4 <ul><ul><li>Phase III Clinical Trials </li></ul></ul><ul><ul><ul><li>Protocol </li></ul></ul></ul><ul><ul><ul><li>Clinical Trial </li></ul></ul></ul>Q2 2010 2008 2009 Q1 Q2 Q3 Q4 <ul><ul><li>Licensure India </li></ul></ul><ul><ul><li>WHO </li></ul></ul><ul><ul><ul><li>Pre-qualification </li></ul></ul></ul>WHO Pre-qualifcation Q3 Q4 80RB Fill Fill 180RB 180RB Licensure 180RB Fill Fill Fill Fill Fill 1yr
  35. 35. Vaccines: India’s Strength FEBRUARY 3, 2009 BIO ASIA 2009 PAGE CONCLUSIONS <ul><ul><li>India has a long and rich history in vaccination </li></ul></ul><ul><ul><li>Strong need for high quality vaccines for an affordable price </li></ul></ul><ul><ul><li>India has a strong and fast growing vaccines industry </li></ul></ul><ul><ul><li>The Indian vaccine companies conclude win-win partnerships with vaccine players from all over the world </li></ul></ul><ul><ul><li>India, the world’s pharmacy…. ……India, the world’s vaccine manufacturer? </li></ul></ul>
  36. 36. FEBRUARY 3, 2009 BIO ASIA 2009 PAGE For more information be invited to: www.intercell. com
  37. 37. Vaccination in India today FEBRUARY 3, 2009 BIO ASIA 2009 PAGE <ul><ul><li>In 1948 India became member country of the WHO </li></ul></ul><ul><ul><li>Establishment of new Indian health care institutions </li></ul></ul><ul><ul><li>First official policy for childhood vaccination in 1978 </li></ul></ul>* 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)
  38. 38. Pharmaceutical Business from Development to Distribution FEBRUARY 3, 2009 BIO ASIA 2009 PAGE BIOLOGICAL E, HYDERABAD – PHARMACEUTICALS <ul><ul><li>From 1977 Biological E Limited has focused on building its pharmaceutical business in India. </li></ul></ul><ul><ul><li>Core competencies are development, manufacturing and marketing of pharmaceuticals. </li></ul></ul><ul><ul><li>Dedicated manufacturing facilities for Solid Dosage Forms, Liquid Orals and Syrups, Parenterals and Active Pharmaceutical Ingredients </li></ul></ul><ul><ul><li>Continuous investment in world-class facilities that will be in accordance with US FDA and EMEA standards </li></ul></ul><ul><ul><li>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 </li></ul></ul>