Fit Biotech to develop an improved vaccine
against tuberculosis

Press Release, free for publication on February 9th at 12.00

FIT to lead a European TB-vaccine consortium

FIT Biotech's CEO comments TBVI's (Tuberculosis Vaccine Initiative) press release (attached) about the need of new TB-vaccines and FIT's participation in a new project.

TBVI is the leading European non-profit organization that stimulates and coordinates the development of new, globally accessible and affordable vaccines based on novel technologies. Tuberculosis still remains a global public health threat. Growing incidence in developing as well as developed countries calls for preventive measures. Also Finland has seen an increase of new TB-infections and there is an epidemic in Russia.

The current BCG-vaccine is suboptimal in terms of safety as well as efficacy. It is not any more widely used in immunization programs in western countries creating possibilities for new epidemics. The technology developed by FIT features several advantages like cost and speed of manufacturing and an improved safety profile. Based on this TBVI has entered into a collaboration agreement with FIT to capitalize the new technology.
Bill and Melinda Gates Foundation and the EC 7th - framework program have been instrumental in supporting the initiation of this European endeavor based on European technologies. FIT's GTU-technology is the most advanced new DNA-technology.

" It goes without saying that we're excited to be elected in TBVI's vaccine project. We take it as proof of the great potential of our technology. We are also proud of the progress made with our HIV-vaccine that is now moving to several new clinical trials in US and Europe supported by public funding. In US an application will be submitted to FDA this spring. FIT is primarily developing a therapeutic HIV-vaccine which is now also being tested as a preventive vaccine. FIT and its patents remain in Finnish ownership and the investments made can be commercialized to benefit local industry."

Clinical development of the vaccine will commence when TBVI has raised the funds needed from a broad group of donors. Public funding is pivotal when developing vaccines against neglected diseases such as TB and HIV. FIT is the coordinator in the new EU-TB-vaccine project with recognized collaborators from Holland and Belgium. Mr. Jelle Thole, TBVI's director appreciates FIT's technology and FIT's commitment in the project representing a unique opportunity for Finnish know-how. FIT expects the project to result in licensing fees as well as a royalty based on future sales. In addition to TB and HIV-vaccine development FIT has targeted also other diseases such as malaria, dengue-fewer and pandemic flu. FIT manufactures all the test vaccines for clinical trials and there are plans to expand manufacturing to meet commercial needs.

For additional information

Please contact CEO Kalevi Reijonen,
tel.+358 40 843 5695
e-mail: kalevi.reijonen@fitbiotech.com

About FIT Biotech Ltd

FIT Biotech is an innovative medical biotechnology company engaged in the development and commercialisation of its proprietary Gene Transport Unit (GTU®) technology and GTU® product applications in DNA vaccination as well as in immuno- and gene therapies.

Attachment
1 Feb 2010

Lelystad - TuBerculosis Vaccine Initiative (TBVI) welcomes the recent Bill & Melinda Gates Foundation's call on governments and the private sector to increase investment in vaccines. "European governments and investors should take their responsibility in filling critical financing gaps in the research and development of urgently needed new vaccines against tuberculosis", says Jelle Thole, director of TBVI.

"We have now seen a historical commitment from the Gates Foundation for universal development of new vaccines. TBVI believes that Europe has to take the leadership in the development of new tuberculosis vaccines as our network proves that developing these vaccines is feasible", continues Thole. "Europe is at the top of science, discovery and knowledge in this field. Expected returns will be huge: millions of lives saved, including in Europe, and maintenance and reinforcement of the capacity of knowledge and innovation."

There are many advanced technologies in Europe that in global perspective have high potential for improved vaccines with lower production costs. TBVI's consortium includes companies which are involved in these advanced vaccine technologies, such as FIT Biotech and Institut Mérieux. Other companies will also join the unique network of around 40 renowned research institutes and universities. "The collaboration of these research institutes with vaccine companies is a guarantee that discoveries will be translated in affordable, effective and safe vaccines."

The European Commission is already strongly committed to research and development of new tuberculosis vaccines. TBVI hopes that individual member states will soon join in supporting its very promising projects.

Note

NOTE TO EDITORS
For more information, please contact:
TuBerculosis Vaccine Initiative: Ms. Erna Balk, Director Communications & Advocacy Relations, Tel: +31 320 29 32 65, erna.balk@wur.nl, www.tbvi.eu

About TBVI

TuBerculosis Vaccine Initiative (TBVI) is an independent non-profit foundation that facilitates the development of safe, more effective vaccines to protect future generations against tuberculosis. Since its formation in 2008, TBVI has brought together an integrated network of European universities, institutes and the private sector in the development of new vaccines that are globally accessible and affordable. Research conducted by TBVI's network has already resulted in new vaccine discoveries, proving that new vaccine approaches can be developed. The organization aims to raise 200 million euros over the next 10 years in its pursuit of eliminating the disease, which currently accounts for 1.8 million deaths annually.

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