7 WHERE THE CHALLENGES ARE? INSTITUTIONSBIOTECHSBIG PHARMA+ Tech TransferBiologicalsAPIs/ReagentsDiagnosticsLicensing-out
8 A NEW SCENARIO20086 corporations with only 10 drugs = 50% of recombinant proteins market (USD 80 billions)
9 Herceptin (mAb α-HER2R) A NEW SCENARIO2008 (USD billions)#6Avastin (mAb α-VEGFR)4484#7Herceptin (mAb α-HER2R)4384#8Aranesp (EPO)3344Neulasta (GCSF-PEG)3318#9#10Lantus (insulina)3130
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 BIO vs Big PHARM Capitalization ∆: 17%USD billions∆: 57%From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013.From 15% to 21% in 3 years
17 BIOORGANIC RESEARCH AND SERVICES, S.A. What do we do?CDMO. Development & Manufacturing of Bioactive Agents.2. For whom?Pharmaceutical and Veterinary Companies.3. What´s our goal?Be an international reference in NICHE DISEASES.
18 Cabbage looper Trichoplusia ni Less investment for more production in a locally sustainable model of protein production.Cabbage looper Trichoplusia niOral infectionBionaturis headquarters & 400 sq-mt production plant in Jerez de la Frontera, Cádiz, Spain.
19 15x decrease in up-front cost. 10x less space. VALUE PROPOSITION15x decrease in up-front cost.10x less space.Sustain local production.
21 LARVAE ARE MASS-REARED FOR PEST CONTROL Industrial production of biological pesticidesBrazil: velvet bean caterpillar, Anticarsia gemmatalisEmbrapa-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 DiseaseBrand name(s)CompanyActive principleVaccines for human useCervical cancerCervarix®GSKL1 protein (VLP)Prostate cancerProvenge®DendreonPSAInfluenzaFluBlok®Protein Sciences4x HAVaccines for veterinary usePCV2Porcilis® PCVMerckPCV2 ORF2 proteinCircoFLEX®B. IngelheimClassical Swine FeverPorcilis Pesti®E2 proteinBiological for veterinary useCanine Parvovirus.Feline leukemia virus, Feline Immunodeficiency Virus.Virbagen Omega®VirbacFeline interferon Ƴ
25 BIONATURIS FLYLIFE STAGES OF THE PRODUCTION PROCESS Master Viral DNAWorking Viral BankManufacturing Viral SeedUpstream ProcessingDownstream Processing 1Downstream Processing 2FormulationLarvae population rearingStages of the production process
26 Animal Health Vaccine Program CANINE VISCERAL LEISHMANIASIS (BNT005)L. Infantum ANTIGENT. cruzi Hsp7015951274Prediction based on data: 3 million doses/dayEntering Leishmania market in Brazil: 200 K doses/yearUSD 100/dose
28 Aquatic Health Program BIONATURIS HDP PROGRAMABCD
29 Aquatic Health Program BIONATURIS ORAL DELIVERYAntigen sequenceLipid Droplet Targeting seq.Formulation, method of preparation, and use for delivery to animals or humans. PCT patent application filed March 2012: FORMULATIONS FOR NON-INVASIVE DELIVERY OF ACTIVE PROTEINS TO AN ANIMAL OR HUMAN. PCT/EP2012/FLYPIDS strategyAntigen sequencePolyproline amphipatic helixFLYTE strategy
30 Aquatic Health Program BIONATURIS ORAL DELIVERY1.5h3hCGFPFT
31 TAKE HOME MESSAGESPermanent 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.Bionaturis Chief Scientific Officer.