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NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH

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Presentation on theme: "NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH"— Presentation transcript:

1 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

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 % World Investment population budget use DRUGS BIOLOGICAL 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?
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 Herceptin (mAb α-HER2R)
A NEW SCENARIO 2008 (USD billions) #6 Avastin (mAb α-VEGFR) 4484 #7 Herceptin (mAb α-HER2R) 4384 #8 Aranesp (EPO) 3344 Neulasta (GCSF-PEG) 3318 #9 #10 Lantus (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

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 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 ni Oral infection Bionaturis headquarters & 400 sq-mt production plant in Jerez de la Frontera, Cádiz, Spain.

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

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

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 FDA/EMA APPROVED BIOLOGICALS MADE IN INSECTS
Disease Brand name(s) Company Active principle Vaccines for human use Cervical cancer Cervarix® GSK L1 protein (VLP) Prostate cancer Provenge® Dendreon PSA Influenza FluBlok® Protein Sciences 4x HA Vaccines for veterinary use PCV2 Porcilis® PCV Merck PCV2 ORF2 protein CircoFLEX® B. Ingelheim Classical Swine Fever Porcilis Pesti® E2 protein Biological for veterinary use Canine Parvovirus. Feline leukemia virus, Feline Immunodeficiency Virus. Virbagen Omega® Virbac Feline interferon Ƴ

24 BIONATURIS MANUFACTURING

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

26 Animal Health Vaccine Program
CANINE VISCERAL LEISHMANIASIS (BNT005) L. Infantum ANTIGEN T. cruzi Hsp70 1 595 1274 Prediction based on data: 3 million doses/day Entering Leishmania market in Brazil: 200 K doses/year USD 100/dose

27 BIONATURIS PRODUCTS

28 Aquatic Health Program
BIONATURIS HDP PROGRAM A B C D

29 Aquatic Health Program
BIONATURIS ORAL DELIVERY Antigen sequence Lipid 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 strategy Antigen sequence Polyproline amphipatic helix FLYTE strategy

30 Aquatic Health Program
BIONATURIS ORAL DELIVERY 1.5h 3h 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. Bionaturis Chief Scientific Officer.


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