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NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH

BIOORGANIC RESEARCH AND SERVICES, S.A. NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH. Juan J. Infante, PhD. BIONATURIS CSO. BIOPHARMACEUTICAL PRODUCTION IN INSECTS. Mind the gaps! How do we see the future. A value proposition. Bionaturis manufacturing. Bionaturis products.

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NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH

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  1. BIOORGANIC RESEARCH AND SERVICES, S.A. NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH Juan J. Infante, PhD. BIONATURIS CSO

  2. BIOPHARMACEUTICAL PRODUCTION IN INSECTS • Mind the gaps! • How do we see the future. • A value proposition. • Bionaturis manufacturing. • Bionaturis products. • Conclusions.

  3. MIND THE GAPS!

  4. Intolerable GAP #1: USE OF MEDICINES 90 % 80 % 10 % 20 % WorldInvestment population budget use BIOLOGICAL DRUGS DRUGS

  5. Intolerable GAP #2: TECH TRANSFER Security/Efficacy/RegulatoryMarket R&I+D INSTITUTIONS BIOTECHS BIG PHARMA IP + Tech Transfer Biologicals APIs/Reagents Diagnostics Licensing-out

  6. HOW DO WE SEE THE FUTURE?

  7. WHERE THE CHALLENGES ARE? HERE! INSTITUTIONS BIOTECHS BIG PHARMA + Tech Transfer Biologicals APIs/Reagents Diagnostics Licensing-out

  8. A NEW SCENARIO 2008 6 corporations with only 10 drugs = 50% of recombinant proteins market (USD 80 billions)

  9. A NEW SCENARIO 2008 (USD billions) Avastin (mAb α-VEGFR) 4484 #6 #7 Herceptin (mAb α-HER2R) 4384 Aranesp (EPO) 3344 #8 3318 Neulasta (GCSF-PEG) #9 Lantus (insulina) 3130 #10

  10. If we add other 9 corporations, we realize that 15 corporations making “only” 83 drugs take 99% of recombinant proteins market.

  11. G. Steven Burrill, CEO of Burrill & Company (San Francisco, CA) "As the industry migrates away from an era of the one-size-fits all blockbuster, the biotechnology industry's strength at developing innovative therapies that meet unmet medical needs and target the molecular mechanisms of diseases gives it an upper hand in creating value," From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013.

  12. G. Steven Burrill, CEO of Burrill & Company (San Francisco, CA) “But as pricing pressures become an increasingly challenging prospect for pharmaceutical and biotechnology companies alike, they will need to find new ways to build relationships with payers, providers, and patients to capture value outside of their products" From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013.

  13. Big BIOvs Big PHARM Capitalization ∆: 17% USD billions ∆: 57% From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013. From15% to21% in 3 years

  14. A NEW SCENARIO distribution manufacturing

  15. A VALUE PROPOSITION

  16. BIOORGANIC RESEARCH AND SERVICES, S.A.

  17. BIOORGANIC RESEARCH AND SERVICES, S.A. What do we do? CDMO. Development & Manufacturing of BioactiveAgents. 2. Forwhom? Pharmaceutical and VeterinaryCompanies. 3. What´sourgoal? Be aninternationalreference in NICHE DISEASES.

  18. Less investment for more production in a locally sustainable model of protein production. Cabbage looperTrichoplusiani Oral infection Bionaturisheadquarters & 400 sq-mtproductionplant in Jerez de la Frontera, Cádiz, Spain.

  19. VALUE PROPOSITION • 15x decrease in up-front cost. • 10x less space. • Sustain local production.

  20. VALUE PROPOSITION Flexibility + speed + security + efficacy + SCALABILITY

  21. LARVAE ARE MASS-REARED FOR PEST CONTROL Industrial production of biologicalpesticides Brazil: velvet bean caterpillar, Anticarsiagemmatalis Embrapa-Soja. A laboratory for the large-scale production of AgMNPV was opened in 2004 with the intention of being capable of infecting 600,000 larvae per day. It yields enough virus to treat up to 1.5 million ha/year. The infected larvae are processed into a wettable powder that involves milling the infected larvae and formulating them into a mixture that contains kaolin.

  22. Baculoviruses were transformed into expression vectors

  23. FDA/EMA APPROVED BIOLOGICALS MADE IN INSECTS

  24. BIONATURIS MANUFACTURING

  25. BIONATURIS FLYLIFE STAGES OF THE PRODUCTION PROCESS Master Viral DNA Working Viral Bank Manufacturing Viral Seed UpstreamProcessing DownstreamProcessing 1 DownstreamProcessing 2 Formulation Larvaepopulationrearing Stages of the production process

  26. Animal Health Vaccine Program CANINE VISCERAL LEISHMANIASIS (BNT005) L. InfantumANTIGEN T. cruziHsp70 1274 1 595 • Predictionbasedon data: 3 million doses/day • EnteringLeishmaniamarket in Brazil: 200 K doses/year • USD 100/dose

  27. BIONATURIS PRODUCTS

  28. Aquatic Health Program BIONATURIS HDP PROGRAM C A D B

  29. Aquatic Health Program BIONATURIS ORAL DELIVERY Antigensequence LipidDropletTargetingseq. Formulation, method of preparation, and use fordeliverytoanimalsorhumans. PCT patent application filed March 2012: FORMULATIONS FOR NON-INVASIVE DELIVERY OF ACTIVE PROTEINS TO AN ANIMAL OR HUMAN. PCT/EP2012/055069. FLYPIDS strategy Antigensequence Polyprolineamphipatichelix FLYTE strategy

  30. Aquatic Health Program 1.5h 3h BIONATURIS ORAL DELIVERY C G FP FT

  31. TAKE HOME MESSAGES • Permanent creativity and innovation in biotechnology and business must lead to a boost in technology transfer. • Bionaturis proposal based on insect larvae biofactories is effectively adding value to active principles for niche diseases and promoting more access to health.

  32. THANKS FOR YOUR ATTENTION! Juan J. Infante, PhD. BionaturisChiefScientificOfficer. juanjose.infante@bionaturis.com www.bionaturis.com

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