STATE SCIENTIFIC CENTER STATE RESEARCH INSTITUTE OF HIGHLY PURE BIOPREPARATIONS

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, todayone 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 Maintenance and Auxiliary Departments INSTITUTE MANAGEMENT Dept. of Biochemical Control Scientific and Technical Board Department for Organization of Research • Molecular Immunology Dept. • - Lab. of • Protein • Biochemistry • Lab. of Immunophar-macology • - Lab. of Adsorbents and Carriers • 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 Lab. of Peptide Chemistry Lab. of Immu- nobiotechnology Center of Clinical Immunology Technical Dept. of Marketing

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