1. 1 Global Health Research How the private sector contribute Bergen, 22. September 2004 Birger Sørensen, President CEO Bionor Immuno AS

2. 2 Private sector – a summary Norway has a number of exciting and promising SMEs –Strong scientific basis –R&D can be directed to diseases that are a priority for developing countries –If public capital is invested private capital is likely to follow SMEs are capable of taking new products and services through clinical trials to the market The typical ”market” for Norwegian SMEs is –In-Licensing companies – normally this will be international pharmaceutical or biotechnological companies Down payment Annual royalty

3. 3 Private sector – added value SMEs have greater flexibility than the large international pharmaceutical companies –Private-Public Partnerships (PPP) can be formed on R&D, production and implementation of technology, and services to support the fight against poverty related diseases Improved aid and aid capacity –A better and more constructive aid can be provided to developing countries by utilizing the resources that are available within the Norwegian scientific community and SMEs A number of new and exiting job opportunities can be created in the SME sector

4. 4 Private sector; incentives Financing and implementation of PPPs –Projects must have a realistic time horizon –SMEs must be give a more active role –Implementation / clinical trials in developing countries must be fully financed SMEs access to equity for GHR require –Grants –Limited restrictions on patents –Acceptable Rate of Return on Equity An alternative ”in-licensing partner” must be defined

5. 5 Concluding remarks Global Health Research Program will be highly welcomed to the private sector given that certain mandatory conditions are met A GHRP encompassing PPP will strengthen –National health research (Norway) –the network to developing countries A GHRP should also as a consequence –Utilize the R&D capacity in Norwegian institutions to evaluate and improve international aid programs

6. 6 Bionor Immuno – an example HIV immunotherapy Aim; Combine HAART with Immunotherapy to obtain longer drug-free periods –Immunization of infected individuals to maintain effective immune responses to HIV-1 that can control the infection in the absence of HAART Reduce exposure to HAART and minimise HAART side effects Impact on the development of resistant viruses by prolonging the stability and efficacy of HAART regimens Improve the quality of life of infected individuals Alleviate the financial burden on health care services –Delay the onset of continuous HAART regimens Immunotherapies will give a valuable insight that can provide a basis for the development of a successful preventative vaccine

7. 7 Bionor Immuno – an example Results as of September 2004 Vacc-4x –Safe –Immunogenic (proliferation, DTH) –Those with high DTH responses have improved CD4 counts and lower viral load compared those with low DTH responses –Significant HAART-free periods attained for the majority of patients (>12 months) As of August 2004, 26 of 40 patients remain off HAART –Those that have resumed HAART were HAART-free for an average of 8 months (3 -14 months) –Patients that remain off HAART have been off HAART for an average of 17 months (13 -20 months) Vacc-5q –Safe and immunogenic