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

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Presentation on theme: "NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH Juan J. Infante, PhD. BIONATURIS CSO BIOORGANIC RESEARCH AND SERVICES, S.A."— Presentation transcript:

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

2 BIOPHARMACEUTICAL PRODUCTION IN INSECTS 1.Mind the gaps! 2.How do we see the future. 3.A value proposition. 4.Bionaturis manufacturing. 5.Bionaturis products. 6.Conclusions.

3 MIND THE GAPS!

4 DRUGS BIOLOGICALDRUGS 90 % 10 % 80 % 20 % World Investment population budgetuse Intolerable GAP #1: USE OF MEDICINES

5 + Tech Transfer Security/Efficacy/Regulatory Market Licensing-out BiologicalsAPIs/ReagentsDiagnostics Intolerable GAP #2: TECH TRANSFER R&I+D IP INSTITUTIONS BIOTECHS BIG PHARMA

6 HOW DO WE SEE THE FUTURE?

7 INSTITUTIONS BIOTECHS BIG PHARMA + Tech Transfer Licensing-out BiologicalsAPIs/ReagentsDiagnostics WHERE THE CHALLENGES ARE? HERE!

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

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

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 USD billions From “Big Biotech Outpaces Big Pharma”. Biopharm International, Apr 17, 2013. ∆: 57% ∆: 17% From 15% to 21% in 3 years

14 A NEW SCENARIO distribution manu factur ing

15 A VALUE PROPOSITION

16 BIOORGANIC RESEARCH AND SERVICES, S.A.

17 1.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. 1.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. BIOORGANIC RESEARCH AND SERVICES, S.A.

18 Cabbage looper Trichoplusia ni Oral infection Bionaturis headquarters & 400 sq-mt production plant in Jerez de la Frontera, Cádiz, Spain. Less investment for more production in a locally sustainable model of protein production.

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

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

21 LARVAE ARE MASS-REARED FOR PEST CONTROL Industrial production of biological pesticides Brazil: velvet bean caterpillar, Anticarsia gemmatalis 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 DiseaseBrand name(s)CompanyActive principle Vaccines for human use Cervical cancerCervarix®GSKL1 protein (VLP) Prostate cancerProvenge®DendreonPSA InfluenzaFluBlok®Protein Sciences4x HA Vaccines for veterinary use PCV2Porcilis® PCVMerckPCV2 ORF2 protein PCV2CircoFLEX®B. IngelheimPCV2 ORF2 protein Classical Swine FeverPorcilis Pesti®MerckE2 protein Biological for veterinary use Canine Parvovirus. Feline leukemia virus, Feline Immunodeficiency Virus. Virbagen Omega®VirbacFeline interferon Ƴ FDA/EMA APPROVED BIOLOGICALS MADE IN INSECTS

24 BIONATURIS MANUFACTURING

25 BIONATURIS FLYLIFE STAGES OF THE PRODUCTION PROCESS 1.Master Viral DNA 2.Working Viral Bank 3.Manufacturing Viral Seed 4.Upstream Processing 5.Downstream Processing 1 6.Downstream Processing 2 7.Formulation 8.Larvae population rearing Stages of the production process

26 CANINE VISCERAL LEISHMANIASIS (BNT005) 1595 1274 L. Infantum ANTIGENT. cruzi Hsp70 Animal Health Vaccine Program  Prediction based on data: 3 million doses/day  Entering Leishmania market in Brazil: 200 K doses/year  USD 100/dose

27 BIONATURIS PRODUCTS

28 BIONATURIS HDP PROGRAM Aquatic Health Program A B C D

29 BIONATURIS ORAL DELIVERY Aquatic Health Program FLYTE strategy FLYPIDS strategy Antigen sequence Lipid Droplet Targeting seq. Antigen sequence Polyproline amphipatic helix 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/EP2012/055069.

30 1.5h3h C G FP FT BIONATURIS ORAL DELIVERY Aquatic Health Program

31 TAKE HOME MESSAGES 1.Permanent creativity and innovation in biotechnology and business must lead to a boost in technology transfer. 2.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. juanjose.infante@bionaturis.com www.bionaturis.com


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