Association “Innovative Pharma” Moscow, 24 March

1. Association “Innovative Pharma”Moscow, 24 March Aram Akopyan

2. InPharma member-companies • Abbott • Amgen • Astra Zeneca • BMS • Boeringer-Ingelheim • Eli Lilly • Janssen-Cilag • MSD • Novartis • Novo Nordisk

3. “InPharma” - Mission “InPharma”'s mission is creating and/or bringing best practices and support legislative basis that provides new medicines for patients by pharma/biotech R&D companies. • 100% dedication to only R&D companies, both International and domestic • Direct public policy advocacy to State on behalf of innovative companies

4. State commitment to HC • Goals: • Improvement of patient access to overall treatment • Increase of medical care availability for all groups of population • Provide medical care in accordance to modern achievements in diagnostics and treatment • Increase of quality of life and expectancy

5. Selected Advances in the 20th Century 1900s – 1940s 1950s – 1970s 1980s – 2000 1980s 1981 – First ACE inhibitor to treat high blood pressure 1986 – First monoclonal antibody treatment 1987 – New class of depression medicines (SSRIs) – First AIDS Rx – First statins to lower cholesterol 1950s 1950 – Discovery of prednisone 1951 – First Rx for depression 1953 – First leukemia Rx 1954 – Polio vaccine 1958 – First diuretic to treat high blood pressure 1900–1929 1900 – U.S. life expectancy is 45 1908 – Tuberculosis vaccine 1922 – Insulin for diabetes 1924 – Tetanus vaccine 1928 – Discovery of penicillin 1990s 1993 – First Alzheimer’s Rx 1994 – New breast cancer Rx - Polio eradicated in the Americas 1995 – AIDS Rx advance (HAART) 1995–97 – Four new classes of oral diabetes Rxs 1997–98 – Advance in Parkinson’s Therapies 1960s & 1970s 1963 – Measles vaccine 1967 – First beta blocker 1968 – First anti-rejection medicines for organ transplants 1972 – Advances in anesthesia 1977 – First non-surgical treatment for ulcers 1978 – First biotech product (synthetic human insulin) 1930s & 1940s 1932 – First antibiotic (sulfa drugs) 1935 – Discovery of cortisone 1938 – First epilepsy Rx 1948 – First chemotherapy Rxs Sources: Innovation.org, Great Moments in Innovation, http://www.innovation.org/index.cfm/nonav/Great_Moments_in_Innovation; NIH, National Institute of Allergy and Infectious Disease, Tuberculosis (TB), Age of Optimism, http://www3.niaid.nih.gov/topics/tuberculosis/Research/researchFeatures/history/historical_optimism.htm.

6. Selected Advances Since 2000 2000–2008 2002 • New classes of blood pressure and cholesterol Rxs • New mAb Rx for rheumatoid arthritis • New class for attention deficit/hyperactivity disorder 2006 • First medicine approved for chronic chest pain in 20 years • First vaccine for the prevention of cervical cancer • New option for a rare leukemia • First once-a-day HIV medicine • 2004 • • New Rx for most common form of lung cancer • • New mAb treatment for colorectal cancer • • New class of treatment for depression • First mAb treatment for multiple sclerosis • • First anti-angiogenic medicine for cancer 2000 • First mAb-targeted chemotherapy • New class for macular degeneration • First HIV medicine approved for children as young as 6 months 2007 • U.S. life expectancy is 78 • New class to treat high blood pressure • First treatment for fibromyalgia • Two new first-in-class HIV drugs 2005 • First new kidney cancer Rx in over a decade • Advance in insomnia therapy • Three new therapies for diabetes • 2003 • First Rx for severe Alzheimer’s • • Human genome mapped • • New class of HIV treatment – • fusion inhibitors • • First biotechnology treatment for asthma 2001 • First molecular targeted cancer Rx for leukemia • First major advance in the treatment of blood poisoning in 20 years • Advance in treatment of hepatitis C * mAb = monoclonal antibody Source: Innovation.org, Great Moments in Innovation, http://www.innovation.org/index.cfm/nonav/Great_Moments_in_Innovation; FDA website, at www.fda.gov.

7. U.S. Life Expectancy Has Climbed Rapidly Over the last fifty years, life expectancy has risen by nearly a decade U.S. Life Expectancy 1950–2005 At Birth (in Years)

8. Extending Life Factors contributing to the decline in heart disease and stroke mortality include better control of risk factors, improved access to early detection, and better treatment and care, including new drugs and expanded uses for existing drugs.3 Decreasing DisabilityReduced disability associated with cardiovascular disease accounts for a significant part of the total reduction in disability – between 19 and 22 percent. The evidence suggests that improvements in medical care, including both increased use of relevant procedures and pharmaceuticals, led to a significant part of this decline.2 “ “ “ “ Medicines' Impact on Health and Quality of Life Medicines extend life, reduce suffering, and enable patients to lead more productive and fulfilling lives “ Improving Quality of Life and Health Outcomes Many examples exist of major therapeutic gains achieved by the industry in recent years… anecdotal and statistical evidence suggests that therapid increases that have been observed in drug-related R&D spending have been accompanied bymajor therapeutic gains in available drug treatments.1

9. Investments in healthcare:proven effectiveness 2008 2007 Expensive Drugs Program Federal dedicated program for socially significant diseases Project Health Federal out-patient reimbursement Hospital purchasing Federal dedicated program for socially significant diseases Project Health Federal out-patient reimbursement Hospital purchasing 2006 2005 Project Health Federal out-patient reimbursement Hospital purchasing Federal out-patient reimbursement Hospital purchasing Significant improvement in demography and health status 8,3% increase of birth rate 2006 vs 2007 3,3% decrease of mortality rate 2006 vs 2007 2 years increase of average life span 10-20% decrease of average hospitalisation rates

10. Impact of Health 2020 concept implementation on innovative industry • Opportunities where we can immediately contribute to partnership with Health 2020 owners: • Sharing best practice at drug insurance programs design other countries • Bringing expertise to treatment standards concept development and implementation • Providing support at establishment of interactive and comprehensive system of patient registration

11. Pharma 2020 Pharma 2020 Initiative, building favorable conditions for development of innovative pharmaceutical market in Russia • Develop joint industry position on priority aspects of Pharma 2020 • Develop Advocacy Plan to communicate industry position and expertise to State

12. “InPharma” – cooperation • Ros Zdrav Nadzor • Ministry of Economic Development • State Duma • Edinaya Rossiya • Ministry of Trade and Industry • Ministry of Health and Social Service

13. Necessary steps for investment climate Harmonization of the Legislation in Russia with ICH Regulations including: • Regulatory issues • IPR protection (DE) • Biologic Regulation

14. Thank You !