Marine Resources & their application to healthcare Yondelis : A successful, high-value application of marine resources

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1 Marine Resources & their application to healthcare Yondelis : A successful, high-value application of marine resources 1

2 Marine Resources & Medicine 1. PharmaMar A Spanish biopharmaceutical company: leader in developing anticancer compounds of marine origin 2. Blue Biotechnology The potential of marine resources for fighting disease. 3. A success story: Yondelis A successful, high-value application of marine resources 2

3 PharmaMar: Zeltia Group Biotechnology Oncology Diagnostics RNAi Consumer Chemicals Air fresheners, Insectisides Varnish, Wood treatment Focused on biotechnology: Leader in developing and commercializing marinederived oncology drugs (since 1986). Other non-core businesses: Molecular diagnostics; targeted RNAi agents with no systemic administration; and consumer chemicals (desde 1939). 3

4 PharmaMar: Key Facts Unique, fully integrated bio-pharmaceutical company. Unique library of marine organisms (> samples). PharmaMar: the first company in the world to develop and market a drug of marine origin to fight cancer (Yondelis ) Marine samples in the collection >70 Countries where Yondelis is sold 300 Employees 110 Patent families 450 Million invested in R&D 700 New chemical entities discovered 5 Compounds in clinical development 4

5 PharmaMar: Pipeline Programa / Indicación clínica Preclínico Fase I Fase II Fase III Comercializac. Colaboradores Yondelis 2 a /3 a línea para sarcoma de tejidos blandos; UE Cáncer de ovario R/R (Yondelis +Doxil); UE Cáncer de ovario R/R (Yondelis +Doxil); EE. UU. 2a/3a para sarcoma de tejidos blandos; EE. UU. 2a/3a para sarcoma de tejidos blandos; Japón. Aplidin Mieloma múltiple R/R Linfoma de linfocitos T R/R PM01183 Cáncer de ovario resistente al platino Cáncer de mama asociado a BRCA 1/2 Estudios combinados con gemcitabina Estudios combinados con doxorrubicina Leucemia aguda Zalypsis Mieloma múltiple PM Tumores sólidos 5

6 Marine Resources & Medicine 1. PharmaMar A Spanish biopharmaceutical company: leader in developing anticancer compounds of marine origin 2. Blue Biotechnology The potential of marine resources for fighting disease. 3. A success story: Yondelis A successful, high-value application of marine resources 6

7 Sources of Bioactive Molecules BioDiversity Bio-Active Molecule Literature & Patents TARGET MEDICINE Combinatorial Chemistry (High Throughput Screening) Target-based Design 7

8 Nature: Good Track Record At least 50% of the 1355 new chemical entities that reached the market over the last 30 years have origins in nature * Vaccine 6% Biological 15 % Synthetic based on Natural 24 % Natural 4 % Natural Derived 22 % Synthetic 29 % Advantages Difficulties Structural Diversity Sourcing (political hurdles) Potency (inherent activity) Legal uncertainty (patents) Largely unexplored Technological Evolution against challenges Scientific (isolation, synthesis.) Opportunity Marine exploration for pharmaceutical purposes < 20 years old. * Newman & Cragg J. Nat. Prod. Rep. 2012, 75,

9 Marine BioDiversity Life originated from the sea 34 of 37 phyla of life in sea (compared to only 17 on land) Sea has higher biodiversity than land Higher chemical diversity Many potential applications Macro-organisms (invertebrates) Micro-organisms (bacteria) Medicines & Research Tools Personal care & Nutrition Environmental DNA (metagenomics) Biomaterials One of most exciting technology sectors. Blue Biotechnology = Marine and aquatic applications of biotechnology. 9

10 Marine Natural Products on the increase Number of marine-derived natural products reported (last 40 years) * Marine Biodiversity: 0.01% of terrestrial samples have antitumor activity vs 1% of marine samples ** Increasing numbers of exciting leads. but marine drug discovery remains largely an academic pursuit. John W. Blunt et al. Nat. Prod. Rep. 2007, 24, ** Keith Glaser & Alejandro Mayer, Biochemical Pharmacology 78 (2009)

11 Commercial Marine-derived Drugs In the last 30 years, only 4 marine medicines have been approved Elan (pain) Conus magus (Cone snail) Eisai (Breast cancer) Halicondrin B (marine sponge) PharmaMar (Cancer) E. turbinata (tunicate) ADC containing MMAE, (dolastatin analog) Seattle Genetics (Linfoma) D. auricularia (mollusc) 11

12 Marine Resources & Medicine 1. PharmaMar A Spanish biopharmaceutical company: leader in developing anticancer compounds of marine origin 2. Blue Biotechnology The potential of marine resources for fighting disease. 3. A success story: Yondelis A successful, high-value application of marine resources 12

13 Ecteinascidia Turbinata E.Turbinata is a small soft bodied marine animal (ascidian, tunicate or sea squirt). Individuals (or zooids) form colonies. Lives in shallow coastal waters (0-15m) and lagoons throughout the Caribbean and temperate regions of the Atlantic and Mediterranean 13

14 Yondelis: A success story BioDiversity Ecteinascidia turbinata: small soft bodied marine animal (sea squirt). Oncology Medicine Bioactive Molecule Approved for ST Sarcoma (July 2007) & platinum-sensitive ovarian cancer (September 2009). Authorized in 73 countries, 39 outside the European Economic Area. Lives in shallow coastal waters (0-15m) in the Caribbean & temperate regions of the Atlantic & Mediterranean. 2001: Co-development Agreement CENTOCOR ORTHO BIOTECH (J&J) outside Europe. 2009: Licence TAIHO PHARMACEUTICAL Japan. 14

15 The Supply Problem - Mariculture Advantages: Only method at start of development!! 1 Tonne = 1g ET-743 Low yielding!! Sea farms Artificial facilities (tanks containing sea-water) 2 1 Production Areas: included the Atlantic coast: - Cadiz (4) - Huelva (5) Limitations 3 Seasonal (May Oct) Cost & security of supply Low yield & variable quality Complex extraction & purification Logistics (transport of frozen organism) 15

16 The Supply Problem Solved! Total Synthesis (1996), > 50 steps 0.1-1g Pseudomonas fluorescens Hemi-synthesis > 100g First large-scale fermentation Commercial route defined (laboratory scale) First synthetic batch [2003 end of mariculture] Synthetic material used for first time in clinical study Current Industrial Process for GMP Yondelis manufacture * * Cuevas & Francesch. Nat. Prod. Rep

17 Yondelis Development Timeline Marine Organism Bioactive Molecule Drug Market E.Turbinata ET-743 Yondelis Extracts of Caribbean tunicate reported to have antitumor effect (Siegel) 1969 Chemical structure elucidated of ET-743 (Reinhart) 6 years 11 years First market approval (STS) E.Turbinata first described by Skramlick (1929) Start Phase I clinical trials (IND, US) & 1997 (EU) Start Phase II clinical trial (STS) Synthetic material used for first time in clinical study. 17

18 MaNaPro ECMNP th International Symposium on Marine Natural Products 8 th European Conference on Marine Natural Products La Toja Island, Galicia, Spain th September,

19 Summary Yondelis demonstrates the potential of the sea and provides an excellent example of a high value application of marine resources. Nature: Excellent track record for drug discovery. Sea: Higher biodiversity than terrestrial samples New compounds: New marine-derived compounds increasing each year. Marine Biodiversity has enormous potential!! 19

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