1. STATE SCIENTIFIC CENTER STATE RESEARCH INSTITUTE OF HIGHLY PURE BIOPREPARATIONS Dr. E.N. SVENTITSKY, INSTITUTE DIRECTOR 7 Pudozhskaya, Saint-Petersburg 197 110, Russia Phone: 235-12-25, 230-48-00, Fax: 230-49-48 E.mail: sv@inshpb.spb.ru

2. Research Institute of Highly Pure Biopreparations Founded in 1974, today one of the leading biotechnological institutions in Russia. Attached to the Russian Ministry of Public Health Owns over 200 inventor’s certificates and patents Collaboration with Russian and foreign research centers and pharmaceutical companies

3. Institute Personnel Institute staff - 154 researchers: 62 candidates and doctors of science 6 members of sectional academies 60 technical support personnel includes biologists, physicists, chemists, physicians, mathematicians Over the last 3 years institute researchers have: published more than 300 articles in national and foreign journals, participated in more than 44 international and 20 national scientific conferences and symposia

4. Institute Activities Development of new biopharmaceuticals based on recombinant proteins, microorganisms and synthetic peptides Development of the efficient drug delivery systems with targeted and prolonged effects Development of HIV-vaccines Development of technologies for production of biochemicals for medicine, veterinary and protection of the environment Manufacture of gene-engineered and bacterial biopharmaceuticals

5. Participation in State Programs Medical industry development and improvements in drug supply Industrial biotechnology development Mother and child health Human genome Vaccines and medical diagnostics of the future Space biotechnology

6. Pilot-Production Section Dept. of Biochemical Control Maintenance and Auxiliary Departments Molecular Immunology Dept. - Lab. of Protein Biochemistry -Lab. of Immunophar- macology - Lab. of Adsorbents and Carriers Departme nt for Organization of Research Molecular Biology Dept. -Lab. of Molecular Genetics - Lab. of Molecular Virology - Electron Microscopy Group Dept. of Completed Formulations - Lab. of New Drug Formulations -Lab. of Applied Microbiology - Lab. of Aerobiology - Group of Drying Scientific and Technical Board Lab. of Peptide Chemistry Lab. of Immu- nobiotechnology Center of Clinical Immunology Technical Dept. of Marketing INSTITUTE MANAGEMENT

7. PRODUCTS B E T A L E U K I N The world’s first drug based on recombinant human interleukin-1 . The preparation is approved to clinical application: as the hemopoiesis recovery drug in cancer patients after the intensive chemo- and radiotherapy courses as an immunostimulant in secondary immunodeficiencies E P O C R I N TM The new domestic drug based on recombinant human erythropoietin. The preparation is approved to clinical application for: treatment of anemias of different origin including those associated with chronic kidney failure, AIDS, chemo- and radiotherapy of oncologic patients treatment of radiation sickness

8. INTERAL Drug formulation based on recombinant human interferon-  2a for therapy of oncologic diseases and infections V I T A F L O R New bacterial preparation based on the original strains of acidophilic bacteria for therapy of dysbacteriosis and accompanying diseases: enhance the body immunological status phase I-II clinical trials

9. Products under Development ARIL Drug based on recombinant interleukin-1 receptor antagonist for therapy of inflammations and autoimmune diseases Phase I-II clinical trials MICROFERON Microencapsulated interferon-alpha for aerosol application in therapy of infections Phase I-II clinical trials

10. BIODESTRUCTIBLE WOUND COVERINGS For treating dermal diseases, trophic ulcers, burns and wounds Chitoskin-IL - wound covering containing liposomal interleukin-1  Chitoskin-Super - wound covering containing superoxide dismutase SELECTIVE HEMOADSORBENTS For efferent medicine Spherocell LP-M - for removing of cholesterol and lipoproteins from plasma and whole blood

11. New Product Ideas Angiogenesis regulating drugs based on recombinant chemokines and their peptide analogs to treat malignant tumors, inflammations, autoimmune diseases Combined medicines based on interleukin-1 and antioxidants Medicines based on synthetic antibacterial peptides Aerosol and liposomal medicines New highly efficient bioinsecticides Development of a new therapy of acute and chronic inflammatory lung lesions using human recombinant interleukin-1 receptor antagonist Development of a combination immunotherapy for chronic viral hepatitis c with interferon alpha and interleukin-1 beta Catalytic antibodies towards TNF-alpha as candidates for treatment of systemic inflammatory reaction syndrome (sirs) and autoimmune diseases

12. Technical Capabilities Research and development of new biopreparations, including new forms and methods for application Production of recombinant cytokines Production of monoclonal antibodies to desired antigens Analytical works Joint manufacture of biopreparations

13. ISTC Funded Projects Development and testing of new effective bioinsecticide formulations and equipment for their aerosol application ISTCDevelopment of the technology for production of new bioinsecticide and aerosol equipment for its effective utilization (2000-2002) #1163 ISTC Development of new highly efficient drugs for treatment of oncologic and infectious diseases, wounds, ulcers, burns ISTCDevelopment of technologies for production of drugs on the base of recombinant and natural proteins (1997-2000) #421 Design of new effective drug delivery systems, high selective hemosorbents, drug aerosols for inhalations, wound healing coverings Development of the technologies for production of new drug delivery systems (1996-1999) #420 PurposePartnerProject Title/DurationNumber Development of the local interleukin-1 therapeutic strategy and study of the mechanisms of interleukin-1 biological activity after local application #1770ISTC Development of IL-1  drug forms for local therapy of patients with pyo-inflammatory processes and tissue lesions