Intercell and Statens Serum Institut Sign Cooperation and License Agreement to Develop Tuberculosis Vaccine -

17.03.2004, 10:33

Vienna/ Copenhagen, 17.3.2004 (APROTEXT) Intercell AG andStatens Serum Institut (SSI) today announced the signature of acommercial license agreement for the development of a newprophylactic tuberculosis vaccine. Under the terms of theagreement, a new vaccine against tuberculosis will be tested inhumans. The vaccine combines recombinant tuberculosis antigensdeveloped by SSI with Intercells synthetic Immunizer IC 31 asadjuvant. The new TB vaccine has demonstrated protection againsttuberculosis infection in a number of relevant animal models andis planned to enter Phase 1 clinical study in 2005. The clinical,and development process will be conducted by SSI. Intercell willreceive upfront and milestone payments, and share the profitsfrom future product sales.

"This approach puts togetherexcellent state of the art technology for TB vaccine antigensand a new superior synthetic adjuvant generating very strong T-cell responses in order to bring the best product to market,"stated Dr. Peter Andersen, Head of Department of InfectiousDisease Immunology at Statens Serum Institut. Tuberculosis killsthree million people each year. Between 2000 and 2020 almost onebillion people will be newly infected, and the disease may alsomake a dramatic return to industrialized countries. One of ourfounding visions at Intercell was to deploy our technologies tofight this scourge. We are delighted that our earlier technicalcollaboration with SSI has led to this commercial agreement withIntercells IC31 adjuvant," commented Intercell CEO Alexander vonGabain. About Intercell AG Intercell is a biotechnology company focusedon the development of vaccines against infectious diseases.Intercells lead products are, a therapeutic Hepatitis C vaccine,which has entered Phase II clinical testing in November 2002, anda vaccine against Japanese encephalitis that has successfullyundergone a Phase II clinical study. A Phase III clinical studyis planned for early 2005. IC 31 is Intercells most promisingsynthetic adjuvant - comprising a peptide and an oligonucleotide- for stimulating both strong B cell and T cell responses. It isbeing developed in-house to enable the next generation ofprotective and therapeutic vaccines, and is an importantcomponent of Intercells vaccine technology. To date, Intercell AGhas succeeded in raising venture capital totalling USD 100million since becoming operational. For further information onIntercell AG visit: www.intercell.com Contact: Mag. Katharina Wieser Corporate CommunicationIntercell AG Phone: +43-1-20620-1116 mailto:kwieser@intercell.com About Statens Serum Institute Statens SerumInstitut (SSI) is a Danish government owned company engaged inthe prevention and control of infectious disease and congenitaldisorders. SSI is a manufacturer of vaccines and otherbiological products, approved by the US FDA, the Europeanregulatory authorities and WHO. SSI is a major manufacturer ofthe current vaccine against Tuberculosis, the BCG vaccine. TheTB research group at SSI is world leading and has made importantcontributions to the understanding of TB infection and immunity.This research has recently resulted in improved diagnostic toolsfor TB as well as recombinant antigens for the development ofimproved TB vaccines. For further information on Statens SerumInstitut visit: www.ssi.dk Contact: Pia Lading Executive VicePresident Statens Serum Institut Tel: +45 3268 3565 Email:pla@ssi.dk About Tuberculosis Tuberculosis (TB) kills approximately 2 million people eachyear. The global epidemic is growing and becoming moredangerous. The breakdown in health services, the spread ofHIV/AIDS and the emergence of multidrug-resistant TB arecontributing to the worsening impact of this disease. In 1993,the World Health Organization (WHO) took an unprecedented stepand declared tuberculosis a global emergency. It is estimatedthat between 2002 and 2020, approximately 1000 million peoplewill be newly infected, over 150 million people will get sick,and 36 million will die of TB - if control is not furtherstrengthened. The current vaccine BCG is one of the oldestpresently in use throughout the world and has a limited efficacyprofile. Infection and transmission TB is a contagious disease. Like thecommon cold, it spreads through the air. Only people who aresick with pulmonary TB are infectious. A person needs only toinhale a small number of TB germs to be infected. Leftuntreated, each person with active TB will infect on averagebetween 10 and 15 people every year. * Someone in theworld is newly infected with TB every second. * Nearly 1%of the world's population is newly infected with TB each year. * Overall, one third of the world's population is currentlyinfected with the TB bacillus. Global and regional incidence Each year, more people are dyingof TB. In Eastern Europe and Africa, TB deaths are increasingafter almost 40 years of decline. In terms of numbers of cases,the biggest burden of TB is in south-east Asia. Factors contributing to the rise in TB * TB kills about 2million people each year (including persons infected with HIV).* More than 8 million people become sick with TB each year. * About 2 million TB cases per year occur in sub-SaharanAfrica. This number is rising rapidly as a result of theHIV/AIDS epidemic. * Around 3 million TB cases per year occurin south-east Asia. * Over a quarter of a million TB cases peryear occur in Eastern Europe. Movement of people is helping the spread of TB Global trade andthe number of people traveling in airplanes have increaseddramatically over the past 40 years. In many industrializedcountries, at least one-half of TB cases are among foreign-bornpeople. It is difficult to treat mobile populations, astreatment takes at least six months and should ideally besupervised. As people move, they may spread TB.

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