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September 13 2002, Press release
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| The business of FIT Biotech is developing |
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THE BUSINESS OF FIT BIOTECH IS DEVELOPING;
1) TEKES CONTINUES TO FUND THE DEVELOPMENT OF THE NOVEL GENE TECHONOLOGY BASED DNA VACCINE PLATFORM TECHNOLOGY (GTU®) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) VACCINE PRODUCT
2) NEW GTU® TECHNOLOGY BASED HIV VACCINE TRIALS AMONG HEALTHY VOLUNTEERS STARTED IN JULY - FIRST TIME IN FINLAND
3) THE OPERATIONS RE-ORGANISED INTO THREE BUSINESS AREAS AND THE FUNDING ROUND 2002 FINALISED
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| Summary: |
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FIT Biotech Plc announced today that it has started new Phase I clinical trials in healthy volunteers to study the applicability of Gene Transport Unit (GTU®) for the development of a preventive HIV vaccine. The trial is designed to test the safety and tolerability of FIT Biotech's investigational vaccine (GTU®-Nef) among healthy volunteers. Information obtained from these studies will be enabled the further development of a preventive HIV vaccine.
The Finnish Technology Agency (Tekes) has confirmed to continue the support of the company's product development work with a new 3,9 M€ funding. "The development of a vaccine for prevention and treatment of the HI-virus infection in the group of the world leaders requires creating of a versatile biotechnology know-how in Finland. This know-how is able to exploit in many ways later on" describes technology specialist Dr. Auli Pere from Tekes the background for the funding decision.
The operations of FIT Biotech have been divided into three business areas: GTU® -technology, vaccines and diagnostics and as a consequence of that leading to an optimized and focused cost structure of the company. The latest funding round of 3,2 Million Euro has been finalized in August.
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| The finnish technology agency (tekes)continues the funding of the development of novel HIV/AIDS -vaccine and GTU® -technology products of FIT Biotech |
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Tekes has granted additional funding to FIT Biotech for the product development programs of the HIV/AIDS vaccine and GTU® -technology. The total amount of funding granted by Tekes is 3,9 Million euro. The funding is partly in the form of R&D subsidy and partly capital loan. "FIT Biotech and Tekes have been co-operating since 1998. The Tekes funding has had a significant positive impact to the technologically demanding product development work of the proprietary DNA vaccine and technology programs" says CEO and President, Pekka Sillanaukee.
"Tekes was interested to continue the funding of this very demanding development work. The development of a vaccine for prevention and treatment of the HI-virus infection in the group of the world leaders requires creating of a versatile biotechnology know-how in Finland. This know-how is able to exploit in many ways later on. With the granted funding Tekes shares the risks of the development work with a company in a project, which in success will have wide social impacts" describes technology specialist Dr. Auli Pere, PhD, from Tekes the background for the funding decision.
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| FIT Biotech has started new clinicla trials, where the safety and tolerability of FIT Biotech's investigational vaccine (GTU® -Nef) is studied in healthy volunteers |
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FIT Biotech Plc has started in Finland in July 2002 two new Phase I clinical trials in healthy volunteers to study the applicability of Gene Transport Unit (GTU®) for the development of a preventive and therapeutic DNA based HIV vaccine.
The trial is designed to study the safety and tolerability of FIT Biotech's investigational vaccine (GTU®-Nef) in healthy volunteers. These studies are expected to be finalized during summer 2003 and the information obtained from trials will enable the further product development of a FIT Biotech's preventive HIV vaccine.
The company has earlier started (Press release November 30th, 2001) the Phase I clinical trials in HIV infected volunteers in December 2001. The clinical trial is expected to be finalized at the end of year 2002 and the information obtained from these studies will enable the further development of FIT Biotech's therapeutic HIV/AIDS vaccine for HIV infected patients.
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| The year 2002 funding round is finalized |
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During the spring 2002 FIT Biotech negotiated with the investors about the future funding of the operations. As a result of the negotiations the investor owners of FIT Biotech Sitra, the funds managed by Bio Fund Management Oy, the funds managed by Concordia Capital Oy, the funds managed by Aboa Venture Management Oy, the funds managed by Sentio Invest Oy and Thomproperties Oy and a new investor, Niemi Foundation (Niemi-säätiö) subscribed totally 3,2 million euro of the convertible capital loan issued by the company.
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| The priority areas and organisation of FIT Biotech |
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FIT Biotech Plc focuses on the development and commercialization of the GTU®-technology and preventive and therapeutic HIV/AIDS-vaccines.
The operations of the company have been divided into three different business areas:
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Development and commercialization of the GTU® -technology (Tartu, Estonia), |
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Development and commecialisation of the GTU® -technology based vaccines (HIV/AIDS, HCV and Melanoma) (Tampere, Finland), and |
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Latex Allergy Diagnostics (Tampere, Finland). |
At the General Annual Meeting of FIT Biotech held on 5th June 2002 the following persons were elected as the members of the Board of the Directors:
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CEO Rabbe Slätis, Karyon Ltd (Chairman of the Board) |
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Director Hannu Hanhijärvi, Sitra Ltd (Vice Chairman of the Board) |
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CEO Erkki Pekkarinen, Bio Fund Management Ltd (Member of the Board) |
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Director Aki Prihti, Concordia Capital Ltd (Member of the Board) |
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Professor Kai Krohn, FIT Biotech Plc (Member of the Board) |
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CEO Pekka Sillanaukee, FIT Biotech Plc (Member of the Board) |
The management team members of FIT Biotech Plc since 15.08.2002 are:
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CEO & President - Dr. Pekka Sillanaukee, PhD, eMBA |
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Senior Vice President, Vaccine Business Area - Prof. Kai Krohn, PhD, MD |
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Vice President, GTU Business Area - Prof. Mart Ustav, PhD |
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Vice President, Diagnostic Business Area - Ms. Tytti Kärkkäinen, Phil Lis |
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Vice President, Operations, Quality and Regulatory Affairs - Ms. Ioana Stanescu, MSc |
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Vice President, Finance & Administration - Mr. Erkki Räty |
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Vice President, Clinical Development - Ms. Ilse Piippo, MD, MSc |
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| The co-operative negotiations finalised |
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In order to optimize the cost structure of business focus, FIT Biotech started the co-operative negotiations in August concerning the company's operations in Finland. After finalizing the negotiations the total number of the personnel will change by ending four permanent employment agreements until the end of 2002. The company estimates that these actions will enable the achievement of the actual business targets of the company.
FIT Biotech Plc employs at present ca. 45 persons from which 10 persons are employed in Tartu, Estonia, 34 persons in Tampere, Finland and one person working in the sales office in Bangkok, Thailand.
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| FIT Biotech Plc |
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FIT Biotech Plc is an innovative global medical biotechnology company engaged in the development and commercialization of novel DNA -vaccines and diagnostic products for unmet clinical needs. These products are based on the company' s Gene Transport Unit (GTU®), recombinant protein and antibody technology platforms. FIT Biotech established its current operations in 1998.
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Tampere, 13th of September 2002
FIT Biotech Plc
Pekka Sillanaukee
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| Further Information |
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CEO & President Pekka Sillanaukee, PhD, eMBA
Tel. +358 3 3138 7000
Fax +358 3 3138 7050
Mobile +358 40 833 1313
pekka.sillanaukee@fitbiotech.com
www.fitbiotech.com
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