THE RISE OF A NATIONAL BIOPHARMACEUTICAL INDUSTRY IN BRAZIL: CONSOLIDATION AND NEXT STEPS.

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1 An Update/Overview on Regulatory Convergence, Predictability, Transparency and Priority Reviews Reginaldo Braga Arcuri THE RISE OF A NATIONAL BIOPHARMACEUTICAL INDUSTRY IN BRAZIL: CONSOLIDATION AND NEXT STEPS. Monday, 24th of August

2 GRUPO FARMABRASIL Non-profit association of nine brazilian pharmaceutical companies focused on innovation and development of new products through international standards and high-quality research.

3 GRUPO FARMA BRASIL STRATEGIC GOALS Consolidating a National Pharmaceutical Industry based on the existing portfolio and new Products. Improving Management and Legal Framework for Innovation Expanding access to medicines Through increasing National supply I N N O V A T I O N

4 RISE AND CONSOLIDATION OF A BRAZILIAN PHARMACEUTICAL INDUSTRY

5 BUILDING ANINDUSTRY Creation, maintenance and expansion of supporting policies Creation of Anvisa Generic Drug Law Patent Law

6 VISION OF THE FUTURE OF BRAZILIAN PHARMACEUTIRCAL INDUSTRY Paths drawn by BNDES Synthetic drugs Continued path Accumulated experience and skills Certified GMP manufacturing facility Generic Drugs Incremental Innovation New Molecules Biotechnology New Path New Skills Manufacturing Plants (biologics) Biosimilars New Biologics Source: Pedro Palmeira/BNDES

7 RESPONSE OF THE BRAZILIAN PHARMACEUTICAL INDUSTRY: INVESTMENTS SYNTHETICS: Last 5 years: = R$ 2.5 billion Projection for the next 5 years: = R$ 5 billion BIOLOGICS: R$ 1,4 billion** 7.00% 6.00% 5.00% 4.00% 3.00% 2.00% 1.00% 0.00% % of net income invested in R&D: : 0.79% Brasil 2.39% Pharmachemical Produtos and pharmaceutical farmoquímicos products e farmacêuticos 6.00% Grupo FarmaBrasil Fonte: IBGE, 2011 e Grupo FarmaBrasil. Elaboração própria. *BIONOVIS R$ 739 million 7 PDP s for Biologics *CRISTÁLIA BIOTECNOLOGIA R$ 100 million 3 PDP s for Biologics HEBRON BIOTECNOLOGIA R$ 50 million *LIBBS BIOTECNOLOGIA R$500.8 million Plant will start operations in PDP s for Biologics *ORYGEN BIOTECNOLOGIA R$500 million 4 PDP s for Biologics Companies with BNDES and FINEP contribution ** Investments from 2014

8 GRUPO FARMABRASIL IN THE PDP PROGRAM PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS) Tech Transfer Partners for biotech drug manufacturing in Brazil:

9 GRUPO FARMABRASIL IN THE PDP PROGRAM PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS) 31 Partnerships for developing and manufacturing Biologic Drugs 23 biologic drugs including second and third-generation biologic drugs cancer rheumatoid arthritis diabetes surgical tissue adhesive growth hormone allergy vaccine Currently procurement of these drugs is around R$ 1,8 billion Source: Brazilian Ministry of Health Savings of R$ 225 million/year Deficit reduction on trade balance of US$ 900 million 68% Outros Others Parceiros 32% Grupo FarmaBrasil

10 FOUNDATIONS FOR THE FUTURE Expansion to American Continent Biolab Biolab Eurofarma/Melinta Libbs Hebron USA Brace Farma (EMS) Eurofarma Centro-América Eurofarma Colômbia/Fábrica MSD Eurofarma Peru Hebron Del Peru Eurofarma Chile Eurofarma Bolívia Eurofarma Uruguai Eurofarma Argentina Cristália/IMA Argentina

11 NEXT STEPS

12 NEXT STEPS TO BIOTECH DEVELOPMENT INBRAZIL IMPROVING REGULATION FOR BIOTECH DRUGS Create the opportunity for companies to discuss their Developing Plans for biotech drugs with the regulatory agency, ANVISA, guarantying more legal and regulatory certainty to the undergoing investments. Regulate Good manufacturing practices (GMP), specifically to biological drugs. Elaborate Guidelines for Registration and Post registration of biological drugs.

13 BRAZILIAN PHARMACEUTICAL INDUSTRY HAS BEEN GROWING INTO A WORLD CLASS INDUSTRY

14 THANK YOU Reginaldo Arcuri Executive President Adriana Diaferia Executive Vice President SBS, Quadra 02, Bloco E, nº 12, 15º andar, Salas nº 1501 e 1502, Edifício Prime Business Convenience, CEP Brasília/DF