The Business of Disease Prevention. Huw Hughes and Paul Wood Veterinary Medicine Research and Development Pfizer Animal Health

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1 The Business of Disease Prevention Huw Hughes and Paul Wood Veterinary Medicine Research and Development Pfizer Animal Health

2 Introduction Technologies & Delivery Manufacturing Challenges Endnote

animal production (cattle) Large animal production (swine) Poultry minor species Goats, sheep, exotics Huge

3 Introduction to Animal Biologicals Complex Wide Client Base Animal Health Biologicals Need to answer different customer needs Basic classes fall into classification by animal husbandry category Pets, sport animals Large animal production (cattle) Large animal production (swine) Poultry minor species Goats, sheep, exotics Huge variation in Price to consumer varying from 0.02 cents per dose to 1000 $ per dose Huge variation in technologies and platforms.

4 Global Animal Health Sales Global sales in 2009 were 18.6 BN USD W Europe E Europe ROW FarEast N.America Other Pharmas MFA Parasiticides Anti-infectives Biologicals Biologicals represent 25% of global sales

5 Veterinary Vaccine Cost Melanoma per dose US$ Cost Neospora Lyme WNV Canine line Feline line Cattle Respiratory Kennel cough BTV 0.01 Mareks Relative No of doses sold

6 Introduction Technologies & Delivery Manufacturing Challenges Endnote

7 Living up to the Promise Biotechnology applications in Animal Health have yielded over 100 new products and services Diagnostics Gene markers for genetic selection Vaccines Biomarkers Biopharmaceuticals

8 Licensed Novel Technologies TECHNOLOGY APPLICATION HOST SPECIES GEOGRAPHY Canarypox vector Distemper virus HA and F Dog, Ferret Americas Canarypox vector Rabies G Cat Canarypox vector FeLV Env, Gag/pro cat EMEA, N. America Canarypox vector Equine Flu HA Horse EMEA (Australia) Canarypox vector WNV prm- E Horse N America Fowlpox vector H5 avian flu poultry S. America Asia HVT Vector Newcastle Disease poultry N America HVT Vector Bursal Disease poultry Global Virus Deletion/truncation IBR Killed virus Cattle Europe Virus Deletion/truncation IBR MLV Cattle Europe Virus Deletion/truncation Aujesky's Pigs N America DNA Infectious haematopoietic necrosis virus Salmon N. America DNA WNV Horse N America DNA Melanoma Dog N America Peptide/protein Interferon omega Dog/Cat Europe Peptide/protein GnRH Pigs Global Peptide/protein Baculo PCV2 Pigs N America Plant NDV Poulltry N America Peptide/protein Lyme Disease (OSP A) Dog N America Fowlpox vector Avian Encephalomyelitis poultry N America HVT Vector Mareks Disease poultry N America Fowlpox vector Laryngotracheitis poultry N America Peptide/protein IFN- Omega cats Europe Chimeric viruses PCV1/2 Pigs N America Vaccinia vector Rabies G Wildllife EMEA, N. America Fowlpox vector Newcastle Disease poultry N America Peptide/protein GnRH (immunotherapeutic for BPH) canine N America Subunit technology Neonatal scours - E coli pili Pigs Global Adjuvant technologies disease prevention, immunotherapeutics All Global

Biopharmaceuticals Biopharma / Nomenclature For AH: Biological = vaccines Biopharmaceuticals = protein-based therapeutics For HH: Biological = large molecule (therapeutic or vaccine) 3 main targets:

9 Biopharmaceuticals Biopharma / Nomenclature For AH: Biological = vaccines Biopharmaceuticals = protein-based therapeutics For HH: Biological = large molecule (therapeutic or vaccine) 3 main targets: Growth enhancement, cancer and immunomodulation 3 types of products at this time with several specific characteristics Anti-peptide vaccine (hormone RF) Bioactive peptides (immunomodulator or antiinfective) Monoclonal antibodies (anti-cancer/immunomodulator/anti-infective) Diverse regulatory environment US: FDA for growth enhancement but the antiinfectives/immunomodulators could be linked to a disease and go through USDA EU: EMEA registration as vaccine (including growth enhancement) or drug

10 Upsides vs. Downsides Substitute for endogenous proteins Small molecules often cannot replace naturally occurring proteins Expand druggable targets Biologics can interact with targets not amenable to small molecules resulting in new mechanisms of action (e.g., protein-protein interactions) Less toxic (no residues) Easier to predict distribution, metabolism and elimination Suitable for EU market that is reluctant to growth inducing drugs Faster to POC Faster development cycles Provide selective targeting Biologics will always be more selective for their targets reducing side effects Reduces expensive medicinal chemistry Reduces expensive HTS No erosion of market by generics to date Immuno-privileged sites Extracellular targets Routes of administration Supply chain issues

11 Vaccine Delivery Technologies DNA Vaccination Control Release Device Rectal Suppository bait Intranasal puffer Transdermal Patch Biodegradable Implant Transgenic Plants Viral/Bacterial Vectors

12 Introduction Technologies & Delivery Manufacturing Challenges Endnote

The Animal Health Global Factory Technologies

13 The Animal Health Global Factory Technologies under the same roof: Bacterial fermentation Roller bottle Cell factory Disposables and Hard Pipe reactors Egg culture Live animals Inspected by: USDA, EMEA/VMD, FDA, JMAFF.. Over 40 products released Final product release For further manufacturing

14 Manufacturing Technologies Necrotic hepatitis of rabbits ANAPLASMOSIS NDV IB FLU IBDV COCCIDIOSIS

15 Disposable Technology Hard pipe vs. Plastic Capital cost vs. consumable cost Dedicated facility to make plastic worth while Running costs Lower running costs Environmental balance plastic disposal vs. CIP fluids Down time Troubleshooting Re-validation/qualification Media runs.. Quality Need consistency Customers need to be aware of/be integrated into change control processes of plastic suppliers

16 Disposable Technologies Cells Non-adherent Cell scale-up Wave bags SUBs (250L) Virus production SUBs (1000L) Controller Finesse Probes Finesse Optical

In Addition The Challenges of Scale Cost

expensive, time consuming and also can be a

Veterinary vaccines typically have little

17 In Addition The Challenges of Scale Cost constraints are critical Scale up should not compromise costs and yields. Inactivation often a bottleneck DSP is expensive, time consuming and also can be a bottleneck. Veterinary vaccines typically have little or no DSP Safety, particularly for pets and sport horses is critical vs. Animal Health Human Health

18 Introduction Technologies & Delivery Manufacturing Challenges Endnote

19 Case Study: Mission Impossible Active ingredient X For use in pets, production animals and wildlife COGs of >0.10 USD per dose Live presentation Stable expression over 10 passages Must pass shed/spread criteria Formulations Lyophilized for companion animals Bait for wildlife RTU for Production animals Refrigerator storage OK, RT preferred Stable for 12 (24 h preferred) hours at 25 to 30 C in bait, 24 months at 4 C

20 Multiple Regulatory Pathways

21 Animal Health Biological Regulation FDA US Biotherapeutics USDA/CFIA N. American Biologicals JMAFF Japan EMEA Europe AQIS Australia Other China, Latin America Autogenous Vaccines USDA (9CFR) Conditional license USDA, EMEA Strain swap Provisions in 9CFR and EMEA Exceptional MA EMEA Flu, FMD, BTV Provisional MA EMEA Biotherapeutics USDA, FDA and/or EMEA MUMS Minor use, minor species

Examples of Speed-to-Market Industry uses a conditional license or provisional market authorization to be First to market Provisional Market Authorizations in EU have included vaccines protecting

Allows vaccine to be available to producers in multiple countries without the rigours of a full MA Conditional licenses in the US are granted to companies with new disease entities (or new field

22 Examples of Speed-to-Market Industry uses a conditional license or provisional market authorization to be First to market Provisional Market Authorizations in EU have included vaccines protecting against PMWS in pigs through sow vaccination. Allows vaccine to be available to producers in multiple countries without the rigours of a full MA Conditional licenses in the US are granted to companies with new disease entities (or new field strains) and are renewable after one year, until a full license is granted Reasonable expectation of efficacy Industry works with regulators to answer specific and urgent needs in the field Vaccine stocks for government use Q Fever, CSF, FMD Exceptional MA BTV, FMD & Influenza Strain updates Influenza swine and equine. Executed in similar ways by both the USDA and EMEA

Timeline for an Emergency ph1n1 Influenza vaccine for pigs Outbreak USDA Policy established Strain available to industry from USDA MS, WS production

23 Timeline for an Emergency ph1n1 Influenza vaccine for pigs Outbreak USDA Policy established Strain available to industry from USDA MS, WS production Efficacy serial production Prelicense serials (field trials waived due to the use of existing technologies and formulations) Approval November Months

24 Introduction Technologies & Delivery Manufacturing Challenges Endnote

25 Basic Tenets of Animal Health Vaccines Superior Efficacy Stronger claims Prevention/reduction Infection/disease Higher proportion of protected animals Less severe clinical signs Reduced shedding Cross-protection Protection in the face of MDA Minimum age Longer DOI Onset of immunity Superior Safety Fewer smaller or no reaction Safe in pregnant/lactating animals Safe in small breeds Vaccination frequency Price COGs low Production improvements Competitive pricing Convenience Combination vaccines Single dose Mass vaccination Needle free injection Longer DOI Route(s) Husbandry compatible Other State of the art High Tech

26 ENDNOTE The Animal Health industry is a complex environment in terms of client base, product mix and technologies. Biotechnology applications have been successfully integrated into product offerings, with over 100 products registered and launched in the field. These new vaccines have been successfully integrated into combinations with conventional vaccines Production methods and registration pathways reflect the complexity of the business. The modern Animal Health factory is extremely versatile, with new manufacturing technologies being optimized to ensure maximum flexibility and speed especially when addressing emergency vaccine requests. Vaccines still need to be safe, efficacious and answer client needs. Technology by itself does not sell products

27 THANKS Pfizer Animal Health Jay Thompson Tedd Childers Hans Draayer Jim Freeman

Vaccines of today and products needed for the short-, intermediate- and longterm. OIE/FAO OFFLU Conference Beijing China December 4-6, 2013

Vaccines of today and products needed for the short-, intermediate- and longterm XU, Wei-Cheng OIE/FAO OFFLU Conference Beijing China December 4-6, 2013 1 Influenza A reservoir & transmission H3N8, (H5N1)