Intercell and Statens Serum Institut Sign Cooperation and License
Vienna/ Copenhagen, March 17, 2004 - Intercell AG and Statens Serum Institut (SSI) today announced the signature of a commercial license agreement for the development of a new prophylactic tuberculosis vaccine.
Under the terms of the agreement, a new vaccine against tuberculosis will be tested in humans. The vaccine combines recombinant tuberculosis antigens developed by SSI with Intercell�'s synthetic Immunizer IC 31 as adjuvant. The new TB vaccine has demonstrated protection against tuberculosis infection in a number of relevant animal models and is planned to enter Phase 1 clinical study in 2005. The clinical, and development process will be conducted by SSI. Intercell will receive upfront and milestone payments, and share the profits from future product sales.
"This approach puts together excellent "state of the art" technology for TB vaccine antigens and 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 Infectious Disease Immunology at Statens Serum Institut.
Tuberculosis kills three million people each year. Between 2000 and 2020 almost one billion people will be newly infected, and the disease may also make a dramatic return to industrialized countries.
"One of our founding visions at Intercell was to deploy our technologies to fight this scourge. We are delighted that our earlier technical collaboration with SSI has led to this commercial agreement with Intercell�'s IC31 adjuvant," commented Intercell CEO Alexander von Gabain.
About Intercell AG
Intercell is a biotechnology company focused on the development of vaccines against infectious diseases. Intercell�'s lead products are, a therapeutic Hepatitis C vaccine, which has entered Phase II clinical testing in November 2002, and a vaccine against Japanese encephalitis that has successfully undergone a Phase II clinical study. A Phase III clinical study is planned for early 2005. IC 31 is Intercell�'s most promising synthetic adjuvant - comprising a peptide and an oligonucleotide - for stimulating both strong B cell and T cell responses. It is being developed in-house to enable the next generation of protective and therapeutic vaccines, and is an important component of Intercell�'s vaccine technology.
To date, Intercell AG has succeeded in raising venture capital totalling USD 100 million since becoming operational.
For further information on Intercell AG visit: www.intercell.com
Mag. Katharina Wieser
About Statens Serum Institute
Statens Serum Institut (SSI) is a Danish government owned company engaged in the prevention and control of infectious disease and congenital disorders. SSI is a manufacturer of vaccines and other biological products, approved by the US FDA, the European regulatory authorities and WHO. SSI is a major manufacturer of the current vaccine against Tuberculosis, the BCG vaccine. The TB research group at SSI is world leading and has made important contributions to the understanding of TB infection and immunity. This research has recently resulted in improved diagnostic tools for TB as well as recombinant antigens for the development of improved TB vaccines.
For further information on Statens Serum Institut visit: www.ssi.dk
Executive Vice President
Statens Serum Institut
Tel: +45 3268 3565
Tuberculosis (TB) kills approximately 2 million people each year. The global epidemic is growing and becoming more dangerous. The breakdown in health services, the spread of HIV/AIDS and the emergence of multidrug-resistant TB are contributing to the worsening impact of this disease.
In 1993, the World Health Organization (WHO) took an unprecedented step and declared tuberculosis a global emergency.
It is estimated that between 2002 and 2020, approximately 1000 million people will be newly infected, over 150 million people will get sick, and 36 million will die of TB - if control is not further strengthened.
The current vaccine BCG is one of the oldest presently in use throughout the world and has a limited efficacy profile.
Infection and transmission
TB is a contagious disease. Like the common cold, it spreads through the air. Only people who are sick with pulmonary TB are infectious. A person needs only to inhale a small number of TB germs to be infected.
Left untreated, each person with active TB will infect on average between 10 and 15 people every year.
Someone in the world 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 currently infected with the TB bacillus.
Global and regional incidence
Each year, more people are dying of TB. In Eastern Europe and Africa, TB deaths are increasing after 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 2 million 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-Saharan Africa. This number is rising rapidly as a result of the HIV/AIDS epidemic.
Around 3 million TB cases per year occur in south-east Asia.
Over a quarter of a million TB cases per year occur in Eastern Europe.
Movement of people is helping the spread of TB
Global trade and the number of people traveling in airplanes have increased dramatically over the past 40 years. In many industrialized countries, at least one-half of TB cases are among foreign-born people. It is difficult to treat mobile populations, as treatment takes at least six months and should ideally be supervised. As people move, they may spread TB.