ZOETIS VACCINE LINE. A Full Line of Companion Animal Vaccines to Suit Your Needs

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1 ZOETIS VACCINE LINE A Full Line of Companion Animal Vaccines to Suit Your Needs 1

2 MAKE THE SHIFT TO AN ALL ZOETIS BIOLOGICALS PORTFOLIO S Serology, Studies, Single Source H High Titer and Low Passage, Helps Protect Against All Strains of Parvovirus I ISG Companion Animal Immunization Support Guarantee F Four Way Lepto; Free Syringes T The #1 Vaccine Franchise 1 Generate Savings Across Zoetis Therapeutic Areas Leveraging the Zoetis Advantage Program 1 GfK Doane Data MAT 01/2016 Total Market MAT Doses 99M 2

3 3 AGENDA BRONCHICINE CAe VANGUARD RAPID RESP VANGUARD B ORAL VANGUARD B (IN) CANINE INFLUENZA VIRUS (H3N2 AND H3N8) VANGUARD L4 VANGUARD PLUS 5 (DHPP) VANGUARD CRLYME LYMEVAX FELOCELL PORTFOLIO LEUKOCELL 2 DEFENSOR VACCINATION ASSURANCE FROM ZOETIS

4 5 THINGS EVERY VETERINARIAN SHOULD KNOW ABOUT ZOETIS CANINE VACCINES Non-infectious Bordetella bronchiseptica vaccine 1 the only subcutaneous Bordetella bronchiseptica (Bb) vaccine on the market Several CIRD vaccines to support Prime Boost Protocols a vaccination concept demonstrated to help maximize vaccine-induced immunity in dogs and people First to market with a conditionally licensed CIV H3N2 vaccine 4 Low reactive Leptospira vaccine uses diafiltration to help remove extraneous protein and delivers an industry-leading lepto vaccine with low reactivity 5 Only core vaccine with 48 months of serology data available AAHA Canine Vaccine Guidelines. Accessed February 28, Source: GfK Doane MAT 01/2016.

5 5 BRONCHICINE CAe

6 THE USE OF BOTH INTRANASAL AND PARENTERAL VACCINES MAY HELP PROVIDE THE BEST PROTECTION SERONEGATIVE DOGS Sequential vaccination with IN prime followed by parenteral boost vaccination was shown to give the best protection 1 BRONCHICINE CAe The booster shot! Monovalent Parenteral Non-infectious 3 Non-adjuvanted SEROPOSITIVE DOGS It has been demonstrated that parenteral vaccination of seropositive dogs leads to a faster and more robust rise in IgG and IgA antibodies. IN vaccination may not be the most effective route as a booster in seropositive dogs due to immune exclusion 2 1 Ellis J, Haines D, West K, et al. Effect of vaccination on experimental infection with Bordetella bronchiseptica in dogs. JAVMA. 2001;218(3): Ellis J, Krakowka GS, Dayton A, et al. Comparative efficacy of an injectable vaccine and an intranasal vaccine in stimulating Bordetella bronchiseptica-reactive antibody responses in seropositive dogs. JAVMA. 2002;220(1): AAHA Canine Vaccine Guidelines. Accessed December 15,

7 DR. ELLIS OFFERS A PEER REVIEWED AND PUBLISHED STUDY EVALUATING THE EFFECT OF BORDETELLA BRONCHISEPTICA VACCINES IN SERONEGATIVE PUPPIES Study 1 Effect of vaccination on experimental infection with Bordetella bronchiseptica in dogs John A. Ellis, DVM, PhD, DACVP, DACVM; Deborah M. Haines, DVM, PhD; Keith H. West, DVM, PhD; J. Hilty Burr, DVM; Arthur Dayton, PhD; Hugh G. G. Townsend, DVM, MSc; Edward W. Kanara, DVM, DABVP; Carrie Konoby, BS; Ann Crichlow, BS; Karen Martin; Garland Headrick, BS JAVMA, Vol 218, No. 3, February 1, Presentation Title 00/00/12 (Optional)

8 PRIME/BOOST STRATEGY HELPED PROVIDE A LOW LEVEL OF COUGHING DOGS FOLLOWING CHALLENGE WITH BORDETELLA BRONCHISEPTICA PERCENTAGE OF DAYS DOGS COUGHED FOLLOWING CHALLENGE WITH B. bronchiseptica 8 Presentation Title 00/00/12 (Optional)

9 DR. ELLIS OFFERS THE ONLY PEER REVIEWED AND PUBLISHED STUDY EVALUATING THE EFFECT OF BORDETELLA BRONCHISEPTICA VACCINES IN ADULT SEROPOSITIVE DOGS Study 2 Comparative efficacy of an injectable vaccine and an intranasal vaccine in stimulating Bordetella bronchiseptica-reactive antibody responses in seropositive dogs John A. Ellis, DVM, PhD, DACVP, DACVM; G. Steven Krakowka, DVM, PhD, DACVP; Arthur D. Dayton, PhD; Carry Konoby, BS JAVMA, Vol. 220, No. 1, January 1, Presentation Title 00/00/12 (Optional)

10 PARENTERAL VACCINATION HELPED PROVIDE THE HIGHEST CONCENTRATIONS OF IgG AFTER VACCINATION SERUM B. bronchiseptica-reactive IgG CONCENTRATIONS AFTER VACCINATION 10 Presentation Title 00/00/12 (Optional)

11 PARENTERAL VACCINATION HELPED PROVIDE THE HIGHEST CONCENTRATIONS OF IgG AFTER VACCINATION 11 Presentation Title 00/00/12 (Optional)

12 PARENTERAL VACCINATION HELPED PROVIDE A HIGH CONCENTRATION OF SERUM IgA AFTER VACCINATION SERUM B. bronchiseptica-reactive IgA CONCENTRATIONS AFTER VACCINATION 12 Presentation Title 00/00/12 (Optional)

13 PARENTERAL VACCINATION HELPED PROVIDE A HIGH CONCENTRATION OF SERUM IgA AFTER VACCINATION 13 Presentation Title 00/00/12 (Optional)

14 DR. ELLIS CONDUCTED A 2014 STUDY THAT SUPPORTS THE USE OF BRONCHICINE CAe AS A BOOSTER SHOT AND REINFORCE EXISTING INFORMATION ON THE DIFFERING IMMUNE RESPONSES SEEN WITH EXPOSURE TO A NOVEL PATHOGEN VS. RE-EXPOSURE. Study 3 Antibody responses to Bordetella bronchiseptica in vaccinated and infected dogs John Ellis, Carrie Rhodes, Stacey Lacoste, Steven Krakowka Can Vet J 2014;55: September, Presentation Title 00/00/12 (Optional)

15 CONFIRMING THE CONCLUSIONS OF ELLIS STUDY #2, A SINGLE DOSE OF PARENTERAL VACCINE (BRONCHICINE CAe) GIVEN TO SEROPOSITIVE DOGS CONSISTENTLY STIMULATED AN INCREASE IN IgG. All of the vaccinated beagles had variably increased concentrations of Bb-reactive IgG antibodies in serum after the first dose of the acellular vaccine, and variable, but usually less, further increased response after the second immunization (Figure 1). 15

16 A SINGLE DOSE OF BRONCHICINE CAe IN SEROPOSITIVE DOGS ALSO STIMULATED A MEASURABLE INCREASE IN SERUM IgA. Similarly, 5 of the 7 vaccinated beagle dogs had variable increases in Bb-reactive IgA antibodies in serum that were less pronounced than the IgG responses (Figure 2). 16

17 ELEVATED IgG Bb-REACTIVE ANTIBODY CONCENTRATIONS IN POST-VACCINATION SERA RESULTED IN INCREASED BACTERICIDAL ACTIVITY IN VITRO. Bactericidal activity of post-vaccination sera (from the beagle dogs) was markedly increased (20 to 56%) compared with pre-vaccination bactericidal values (Figure 3). 3 17

18 PARENTERAL VACCINATIONS ARE STANDARD FOR MEMBERS OF THE FAMILY Bronchicine CAe is the only parenteral Bordetella bronchiseptica vaccine for dogs. Bordetella pertussis and Bordetella bronchiseptica are closely related. 1 The presence of vaccine-induced serum antibodies is a good correlate of immunity against B. pertussis in children 2 and against B. bronchiseptica in dogs. 3 1 Parkhill J, Sebaihia M, Preston A, et al. Comparative analysis of the genome sequences of Bordetella pertussis, Bordetella parapertussis and Bordetella bronchiseptica. Nat Genet. 2003;35(1): Cherry JD, Gombein J, Heininger U, Stehr K. A search of serologic correlates of immunity to Bordetella pertussis cough illnesses. Vaccine. 1998:16(20): Ellis JA, Hanes DM, West KH, et al. Effect of vaccination on experimental infection with Bordetella bronchiseptica in dogs. JAVMA. 2001;218(3):

19 ALL ROUTES OF BORDETELLA BRONCHISEPTICA VACCINE ADMINISTRATION ARE NOT EQUAL BIVI MERCK ZOETIS Mucosal Administration YES YES YES Subcutaneous Administration NO NO YES Killed (Non-Infectious) Option Available 1 NO NO YES Routes of Administration Studies with Puppies / Adults?? YES Prime/Boost Protocol Available NO NO YES AAHA Canine Vaccine Guidelines. Accessed December 15, Return to Agenda 19

20 20 VANGUARD RAPID RESP

21 VANGUARD RAPID RESP OVERVIEW 0.5 ml Mucosal response HIGHLY EFFICIENT Intranasal Respiratory Vaccines Flexible antigenic options: Bb / CPiV / CAV-2 Bb / CPiV Bb Demonstrated safe and efficacious via field safety and immunogenicity studies VANGUARD RAPID RESP 3 LABEL For vaccination of healthy dogs at 8 weeks of age or older as an aid in preventing respiratory disease caused by canine adenovirus Type 2 (CAV-2), canine parainfluenza caused by canine parainfluenza virus (CPiV), and disease caused by Bordetella bronchiseptica Administer a single 0.5 ml-dose intranasally Annual revaccination with a single dose is recommended SYRINGE AND SYRINGE FREE OPTIONS Syringe Free Applicator To help reduce the potential for accidental injections 21

22 VANGUARD RAPID RESP VACCINES ARE THE FIRST MUCOSAL BORDETELLA BRONCHISEPTICA VACCINES WITH A 1 YEAR DURATION OF IMMUNITY CLAIM GROUP VACCINE n T01 none 16 T02 Vanguard Rapid Resp 16 VACCINATION B. bronchiseptica STUDY DAY ROUTE CHALLENGE 0 IN Day 370 Aerosol challenge RESULTS The vaccine reduced the duration of coughing in dogs by 84% The vaccine reduced B. bronchiseptica shedding by 96% An antibody response was induced upon vaccination in all dogs and maintained until challenge A stronger antibody response was seen in vaccinated dogs after challenge Data on file, Study Report No R , Zoetis Inc. 22

23 VANGUARD RAPID RESP VACCINES DEMONSTRATED TO BE EFFECTIVE IN LABORATORY STUDY GROUP VACCINE n T01 none 16 T02 Vanguard Rapid Resp 16 VACCINATION B. bronchiseptica STUDY DAY ROUTE CHALLENGE 0 IN Day 42 Aerosol challenge RESULTS The vaccine significantly reduced the duration of nasal shedding of the challenge organism by 80% with a p-value < Challenge resulted in cough in 100% of the controls indicating challenge was successful Vaccine reduced cough in vaccinates post-challenge compared to controls 2 consecutive observations: 93.8% controls coughed, 0% of vaccinates coughed Data on file, Study Report No. 3161R , Zoetis Inc. 23

24 VANGUARD RAPID RESP VACCINES DEMONSTRATED TO BE SAFE IN FIELD SAFETY STUDY A FIELD SAFETY STUDY USING VANGUARD RAPID RESP 3 WAS CONDUCTED IN 614 CLIENT OWNED DOGS CLINICAL SIGNS ASSOCIATED WITH ABNORMAL HEALTH EVENT PERCENT OF ANIMALS (n=614) 15:00 No abnormal health events or reactions were reported in the immediate 15-minute post-vaccination period Observed abnormal health events for up to 14 days after vaccination: Anorexia 0.16% Cough 1.14% Emesis 0.49% Lethargy 0.49% Pruritus 0.16% Pyrexia 0.33% Rhinitis 0.33% Sneezing 1.30% Data on file, Study Report No. B961-R-US , Zoetis Inc. 24

25 ZOETIS PROVIDES MULTIPLE OPTIONS FOR YOUR PRACTICE ZOETIS BIVI MERCK Bb, CPiV, CAV-2 IN Bb, CPiV IN Bb IN x x Bb PO x Subcutaneous boosting options for Bb, CPiV, CAV-2 x x 0.5 ml IN x Traditional syringe option Syringe-free option x Return to Agenda 25

26 26 VANGUARD B ORAL

27 VANGUARD B ORAL 1 ml Mucosal response CONVENIENT Oral Vaccine for Bordetella bronchiseptica Zoetis offering for those who prefer to administer B. bronchiseptica vaccines orally Demonstrated safe and efficacious via field safety and immunogenicity studies VANGUARD B ORAL LABEL For vaccination of healthy dogs at 8 weeks of age or older as an aid in preventing canine infectious tracheobronchitis (kennel cough) caused by Bordetella bronchiseptica Administer a single 1mL-dose orally into the buccal pouch Annual revaccination with a single dose is recommended SYRINGE AND SYRINGE FREE OPTIONS Syringe Free Applicator To help reduce the potential for accidental injections 27

28 VANGUARD B ORAL DEMONSTRATED TO BE EFFECTIVE IN LABORATORY STUDY GROUP VACCINE n T01 none 16 T02 Vanguard B Oral 16 VACCINATION STUDY DAY ROUTE 0 PO B. bronchiseptica CHALLENGE Day 21 Aerosol challenge RESULTS 28 The vaccine significantly reduced coughing, p= in comparison to the controls Challenge resulted in two consecutive coughs in 75% of the controls, indicating challenge was successful 100% of control dogs coughed in multiple (not necessarily consecutive) periods after the challenge No adverse events were noted during the study Data on file, Study Report No. B862R-US , Zoetis Inc.

29 VANGUARD B ORAL VACCINE WAS DEMONSTRATED TO BE SAFE IN FIELD SAFETY STUDY A FIELD SAFETY STUDY USING VANGUARD B ORAL WAS CONDUCTED IN 321 CLIENT OWNED DOGS 15:00 ONE dog was reported to have a brief episode of vomiting in the immediate 15-minute post-vaccination period Observed abnormal health events for up to 14 days after vaccination: CLINICAL SIGNS ASSOCIATED WITH ABNORMAL HEALTH EVENT PERCENT OF ANIMALS (n=321) Alopecia 0.31% Anorexia 0.62% Dermatitis 0.31% Diarrhea 2.49% Emesis 1.56% Fungal Skin Infection 0.31% Lethargy 1.93% Pyrexia 0.62% Retching 0.62% Skin Edema 0.31% Data on file, Study Report No. B961R-US , Zoetis Inc. Return to Agenda 29

30 30 VANGUARD B (IN)

31 VANGUARD B (IN) AIDS IN PREVENTING KENNEL COUGH CAUSED BY BORDETELLA BRONCHISEPTICA Vanguard B (IN) contains an avirulent live culture of Bordetella bronchiseptica (Bb) for intranasal (IN) vaccination of healthy dogs and puppies at least 3 weeks of age or older as an aid in preventing kennel cough (canine infectious tracheobronchitis) caused by B. bronchiseptica The intranasal administration of Vanguard B is designed to promote a strong mucosal antibody response 1 Vanguard B (IN) is safe for use in puppies as young as 3 weeks of age A key part of a PRIME (Vanguard B (IN)) / BOOST (Bronchicine CAe) Protocol of Care 31 1 Ellis J, Haines D, West K, et al. Effect of vaccination on experimental infection with Bordetella bronchiseptica in dogs. JAVMA. 2001;218(3): Return to Agenda

32 CANINE INFLUENZA VIRUS H3N2 H3N8 32

33 CIV CLINICAL SIGNS CAN BE SEVERE CIV IS A DISEASE THAT IS: Highly contagious 1 A risk for dogs of any breed, age, sex, or health status 1 Difficult to diagnose Associated with symptoms that can be severe in some cases Best to prevent Multiple outbreaks seen across U.S. 1 Accessed February 27,

34 CIV CAN BE A RISK TO YOUR PRACTICE RISK TO YOUR PRACTICE The hospital s reputation can be at stake Boarding may be closed from days to weeks Waiving various fees and product charges Lost revenues CONTAMINATION COULD MEAN Literally following pets and owners with a mop Telling healthy patients not to come in Free exams for dogs 34

35 HERD IMMUNITY MATTERS WHEN PROTECTING POPULATIONS AGAINST THE SPREAD OF CIV Not immunized but still healthy Immunized and healthy Not immunized, sick and contagious When no one is immunized disease spreads through the population. When some of the population is immunized disease spreads through some of the population. When most of the population is immunized spread of disease is constrained.

36 36 CANINE INFLUENZA VACCINE, H3N2, KILLED VIRUS* STRAIN: CANINE INFLUENZA VIRUS H3N2, A/CANINE/ILLINOIS/12191/2015 Conditionally licensed by USDA Aids in the control of disease associated with canine influenza virus H3N2 HEALTHY DOGS 8 WEEKS OF AGE AND OLDER 2 doses, 3 weeks apart Annual revaccination with a single dose recommended 25 x 1 dose packages available A NEW VACCINE ON A TRUSTED PLATFORM TO HELP PROTECT DOGS FROM OUTBREAKS Zoetis has achieved a conditional license for this product to help swiftly address outbreaks *This product license is conditional. Efficacy and potency studies are in progress.

37 VANGUARD CIV (H3N8) KILLED WHOLE VIRUS VACCINE (H3N8) IOWA 05 STRAIN Aids in the control of disease associated with CIV Demonstrated to help reduce incidence and severity of lung lesions and incidence and duration of clinical cough and viral shedding 1 HEALTHY DOGS 8 WEEKS OF AGE AND OLDER 2 doses, 3 weeks apart Annual revaccination with a single dose recommended 25 x 1 dose packages available 1 Data on file, Study Report No. 3161R , Zoetis Inc. 2 Data on file, Study Report No. 3167R , Zoetis Inc. DEMONSTRATED SAFETY 691 client-owned dogs 2 No significant adverse events were observed Evaluation at time of vaccination (1,359 doses administered): 4.3% showed minor discomfort (vocalization), some (4%) biting or scratching at site of vaccination, no abnormal attitude was observed in any dogs Adverse events being attributed to Vanguard CIV through 10 days after the 2 nd vaccination: 1.3% of client-owned dogs experienced mild, self limiting and typical AEs associated with vaccination. None required hospitalization. DEMONSTRATED EFFICACY 1 In a CIV H3N8 challenge study, using a heterologous challenge strain from a 2008 Colorado outbreak, dogs vaccinated with Vanguard CIV (H3N8): All seroconverted Reduced CIV shedding and lung consolidation Return to Agenda 37

38 38 VANGUARD L4

39 LEPTO MAY BE A PROBLEM AS CLOSE AS YOUR OWN BACKYARD. MAKE IT A CORE VACCINE FOR AT-RISK DOGS 39

40 LEPTO CAN LURK IN THE URBAN JUNGLE AS WELL MAKE VANGUARD L4 PART OF YOUR RECOMMENDED VACCINE PROTOCOL Available in three formulations: Vanguard L4, Plus 5 L4 and Plus 5 L4 CV Each dose is microfiltered 5 times with our proprietary diafiltration process to help remove extraneous proteins with improved potential to help minimize adverse reactions Efficacy confirmed against all four of the most common Lepto serovars: icterohaemorrhagiae, canicola, grippotyphosa and pomona Return to Agenda 40

41 41 VANGUARD PLUS 5 (DHPP)

42 THE CONFIDENCE OF CLINICAL EVIDENCE VANGUARD VACCINES ARE BACKED BY SEROLOGY DATA GATHERED UNDER THE SAME CONDITIONS THAT YOUR CLIENTS PETS EXPERIENCE EVERY DAY DOCUMENTED BY PEER-REVIEWED DATA AND PUBLISHED IN THE JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION Duration of serologic response to five viral antigens in dogs Douglas E. Mouzin, MS, MBA; Marianne J. Lorenzen, DVM; John D. Haworth, DVM, PhD; Vickie L. King, PhD J Am Vet Med Assoc 2004;224:55-60 METHODS 322 client-owned dogs from 44 US and Canadian practices dogs had no disease history involving the 5 study pathogens Documented history of primary vaccination series and at least 1 revaccination 8-16 months later with Vanguard vaccines only On day 0 blood samples were collected and the dogs were revaccinated 5-7 days later blood samples were taken again and samples were sent to the Cornell University Veterinary Diagnostics Laboratory (CUVDL) for evaluation Serologic response was measured for 5 key antigens in assays by CUVDL 42

43 DURATION OF SEROLOGIC RESPONSE TO FIVE VIRAL ANTIGENS IN DOGS 1 In most dogs vaccination induced a response that lasted up to and beyond 48 months for all 5 antigens (CDV, CAV-1, CAV-2, CPV, and CPiV*) An animal was classified a responder if: Antibody levels for a specific antigen were at or above predetermined levels (CUVDL) on day 0 2 OR The antibody level increased 4-fold during the week between vaccination at day 0 and the 2 nd blood sample PERCENT RESPONDERS OVER TIME CANINE CANINE SEROLOGIC RESPONSE BY ANTIGEN PERCENTAGE AT 6-MONTH INTERVALS SINCE LAST VACCINATION ANTIGEN OVERALL MONTHS MONTHS MONTHS MONTHS MONTHS MONTHS >48 MONTHS CDV 98.1% 99.2% 95.2% 100% 97.6% 100% 100% 94.7% CAV % 96.6% 100% 100% 97.4% 100% 100% 100% CAV % 99.2% 98.3% 100% 100% 100% 90.9% 100% CPiV 100% 100% 100% 100% 100% 100% 100% 100% CPV 98.1% 98.3% 100% 97.9% 95.2% 100% 90.9% 100% CDV=Canine Distemper Virus, CAV=Canine Adenovirus, CPiV=Canine Parainfluenza Virus, CPV=Canine Parvovirus *Protective value of circulating antibodies for CPiV have not been established. 1 Mouzin DE, Lorenzen MJ, Haworth JD, et al. Duration of serologic response to five viral antigens in dogs. J Am Vet Med Assoc. 2004;224: Cornell University Veterinary Diagnostic Laboratory standards for minimum positive serologic response were SN titers 1:32 for CDV, 1:16 for CAV-1, CAV-2, and CPiV, and HI titer 1:80 for CPV. 43

44 HIGH TITER, LOW PASSAGE PARVOVIRUS: VANGUARD PLUS 5 (DHPP) Titers: Contains the highest labeled viral titers in the industry (At least 10 million parvovirus particles per dose) Passages: Only passed through cell culture 37 times. This represents the fewest labeled passages in the industry Vanguard Plus 5 has been demonstrated to narrow the window of susceptibility in young dogs with maternally derived antibody 1 1 Coyne MJ. Seroconversion of puppies to canine parvovirus and canine distemper virus: A comparison of two combination vaccines. J Am Anim Hosp Assoc 2000; 36:

45 VANGUARD PLUS 5 L4 IS ALSO AVAILABLE Vanguard Plus 5 L4 helps protect against canine distemper, canine adenovirus type 2 (CAV-2), (and helps cross protect against infectious canine hepatitis, also known as canine adenovirus type 1), canine parainfluenza virus, parvovirus and 4 serovars of Leptospira For dogs 6 weeks of age or older Give 1 ml Vanguard Plus 5 L4 IM or SQ Give 2 doses, each 3 weeks apart If primary vaccination is given before 9 weeks of age, give 3 doses, 3 weeks apart 45

46 VANGUARD COMBINATIONS PERFORMANCE MEETS FLEXIBILITY PRODUCT BORDETELLA BRONCHISEPTICA Vanguard B (IN) + DISTEMPER VIRUS ADENOVIRUS-2 PARAINFLUENZA VIRUS PARVOVIRUS CORONAVIRUS LEPTOSPIRA 4 SEROVARS CIV MEASLES VIRUS Vanguard CIV (H3N8) + CANINE INFLUENZA VIRUS, H3N2, KILLED VIRUS* + Vanguard CV + Vanguard DA 2 MP Vanguard DA 2 P Vanguard L4 + Vanguard Plus 5 L4 CV Vanguard Plus 5 L Vanguard Plus Vanguard Plus 5 / CV Vanguard Plus CPV + *This product license is conditional. Efficacy and potency studies are in progress. Return to Agenda 46

47 LYME DISEASE VACCINES VANGUARD CRLYME LYMEVAX 47

48 LYME DISEASE: THE THREAT IS REAL FOR DOGS Lyme disease is a painful disease and can be fatal Lyme disease is highly endemic in many parts of the US Antibiotics are not always effective in clearing Borrelia burgdorferi 1 B. burgdorferi express outer surface protein A (OspA), in the tick, and outer surface protein C (OspC), in the tick and the dog OspC expression is needed for B. burgdorferi to transmit to mammalian hosts 2 1 Straubinger RK, Summers BA, Chang Y, Appel MJ. Persistence of Borrelia burgdorferi in experimentally infected dogs after antibiotic treatment. J Clin Microbiol. 1997; 35(1): Stevenson B., Schwan TG., Rosa PA. Temperature-related differential expression of antigens in the Lyme spirochete Borrelia burgdorferi. Infect. Immun. November 1995;63(11):

49 OspC IS A HIGHLY DIVERSE PROTEIN In one study, 11 types of OspC have been demonstrated in canine infections in the US 1 The predominant types of OspC appear to differ between dogs and humans 1 Each B. burgdorferi is capable of expressing only one type of OspC 1 Ticks are almost always infected with multiple B. burgdorferi organisms and therefore multiple types of OspC can be expressed after a blood meal Antibody response to OspC is type specific 1 1 Rhodes D et al., Identification of Borrelia burgdorferi OspC genotypes in canine tissue following tick infestation: implications for Lyme disease vaccine and diagnostic assay design, Veterinary Journal. 2013;198:

50 VANGUARD CRLYME: BROAD COVERAGE IS BETTER COVERAGE ROUTE 1 ml subcutaneous vaccine LABEL For vaccination of healthy dogs at 8 weeks of age or older as an aid in the prevention of clinical disease and subclinical arthritis associated with B. burgdorferi Dogs should receive an initial series of 2 doses administered 3 weeks apart Annual Revaccination Recommended EFFICACY AND SAFETY Laboratory Tick Challenge and Field Safety Study FIRST AND ONLY CHIMERIC RECOMBINANT Lyme vaccine on the market Helps provide coverage to outer surface protein A (OspA), found in the tick, and contains multiple types of outer surface protein C (OspC), found in the tick and dog Chimeric recombinant technology helps provide low reactivity 50

51 DEMONSTRATED EFFICACY IN A LABORATORY CHALLENGE STUDY USING WILD CAUGHT TICKS 1 Objective: Demonstrate the ability of VANGUARD crlyme to aid in the prevention of clinical disease and subclinical arthritis associated with Borrelia burgdorferi Methods: 36 healthy beagles (8 9 weeks of age) with negative Lyme C 6 serology were randomized in a 155-day tick challenge study. Dogs were randomly divided into three groups. Vaccinates and placebo vaccinated controls received two injections, three weeks apart. They were challenged with wild caught ticks. The third group consisted of non-vaccinated, non-challenged controls that received identical care throughout the study. Group 1: 16 dogs received placebo Group 2: 16 dogs received VANGUARD crlyme Group 3: 4 dogs in sentinel group were not vaccinated or challenged Demonstrated Performance with: C 6 Antibody Test OspA and OspC Antibody Titers Joint Histopathology 1 Data on file, Study Report No. B865R-US , Zoetis Inc. 51

52 METHODS TICK CHALLENGE LABORATORY EFFICACY STUDY TIMELINE Day /78 117/ /155 Week Vaccination Phase Challenge Phase Vaccinations (2 Doses): Vanguard crlyme (n=16) Placebo Control (n=16) Tick Challenge Infestation (10 Days) = Serum Sample = Skin Biopsy Necropsy (Histopath) 1 Data on file, Study Report No. B865R-US , Zoetis Inc. 52

53 EFFICACY DEMONSTRATED BY C 6 ANTIBODY TEST RESULTS 1 IDEXX C 6 SNAP RESULTS AT 30, 60, 90 DAYS POST-CHALLENGE There was a significant difference (P<0.0001) in the prevention of Borrelia burgdorferi infection conferred by vaccination After challenge, all dogs in the placebo (control) group tested positive All dogs in the sentinel group were negative at all time points One dog in the product treatment group tested positive on SNAP test at one time point 30 days post-challenge IDEXX SNAP is a trademark of IDEXX Laboratories, Inc. 1 Data on file, Study Report No. B865R-US , Zoetis Inc. 53

54 VANGUARD CRLYME DEMONSTRATED A ROBUST ANTIBODY RESPONSE POST-VACCINATION 1 VACCINATIONS AT DAYS 0 AND 21; WILD CAUGHT TICK CHALLENGE FROM DAYS OspA ANTIBODY TITERS 32,768.0 OspC ANTIBODY TITERS 8,192.0 Vaccine 1,024.0 Challenge Day 42 Placebo 1, Challenge Day 42 Placebo Vaccine 32.0 Day 0 Day 21 Day 35 Day 77 Day 117 Day Day 0 Day 21 Day 35 Day 77 Day 117 Day 153 No Increase in OspA or OspC Antibodies with Vanguard CRLYME Vaccinates Post-Tick Challenge, Helping Demonstrate Protection Against B. burgdorferi infection HELPS PROVIDE BROAD ANTIBODY RESPONSE 1 Data on file, Study Report No. B865R-US , Zoetis Inc. 54

55 HISTOPATHOLOGY 1 INFLAMMATION GRADED: TREATMENT 2 OR HIGHER IN SUBDERMIS 1 OR HIGHER IN AT LEAST ONE JOINT 2 OR HIGHER IN AT LEAST ONE JOINT 2 OR HIGHER IN 2 OR MORE JOINTS T01 14/16 13/16 13/16 9/16 T02 0/16 9/16 0/16 0/16 NTX 0/4 3/4 0/4 0/4 T01 = Placebo T02 = Product NTX = Sentinels Background Inflammation 1 Data on file, Study Report No. B865R-US , Zoetis Inc. 55

56 VANGUARD CRLYME FIELD SAFETY STUDY DEMONSTRATED FAVORABLE RESULTS 1 OVERVIEW 620 dogs enrolled, 3 geographic regions, 13 sites 611 dogs completed (98.5%) 1,232 vaccine doses conducted per label instructions Puppies and adult dogs were represented in the group 1/3 of dogs were 8 weeks IMMEDIATE POST-VACCINATION REACTIONS (<30 MINS POST-VACCINATION) ABNORMAL HEALTH EVENT PERCENT OF INJECTIONS (N=1231) Injection Site 0.08% Injection Site Paresthesia 0.24% Vocalization at Administration 0.73% LATE POST-VACCINATION REACTIONS (>30 MINS 14 DAYS POST-VACCINATION) ABNORMAL HEALTH EVENT PERCENT OF INJECTIONS (N=1231) Anorexia 0.08% Diarrhea 0.16% Hyperthermia 0.08% Injection Site Edema 3.81% Injection Site Pain 0.32% Lethargy 0.24% Muscle Tremor 0.08% 1 Data on file, Study Report No. B865R-US , Zoetis Inc. 56

57 KEY ADVANTAGES OF VANGUARD CRLYME VANGUARD DURAMUNE CRLYME LYMEVAX LYME NOBIVAC LYME RECOMBITEK LYME Manufacturer Chimeric X X X X Recombinant X X X OspA Antigen Number of OspC Antigens Annual Revaccination Companion Animal Immunization Support w/o Pre-vaccination Diagnostics X X X 57 Duramune Lyme is a trademark of Boehringer Ingelheim Vetmedica, Inc. Nobivac Lyme is a trademark of Intervet Canada Corp., a subsidiary of Merck & Co., Inc. Recombitek Lyme is a trademark of Merial.

58 VANGUARD CRLYME SUMMARY First and only canine Lyme disease vaccine with a recombinant OspA and OspC chimeric protein Only vaccine that considers OspC variability; includes antigenic material from seven types of OspC Reduced extraneous protein Safe, low reactivity Backed by Companion Animal Immunization Support Guarantee Return to Agenda 58

59 LYMEVAX

60 LYMEVAX HELPS INDUCE A BROAD- SPECTRUM IMMUNE RESPONSE LYMEVAX IS A MULTI-ANTIGENIC BACTERIN THAT PRODUCES ANTIBODIES TO OspA, OspC, AND OTHER VACCINE ANTIGENS 1 LymeVax is composed of killed B. burgdorferi with a non-aluminum based adjuvant. It is a two strain vaccine designed to help induce a broad antibody response Lyme vaccines like LymeVax that produce a multi-antigenic response may afford broader protection than those that limit their target to that of OspA 1 Data on file, Study Report No. B R, Zoetis Inc. 60

61 LYMEVAX IS HIGHLY EFFECTIVE; CONFIDENCE DEMONSTRATED BY MULTIPLE STUDIES Data on file, Study Report No , 22670, 22671, 22672, 22677, and 25024, Zoetis Inc. 61

62 LYMEVAX : MORE THAN A 20 YEAR TRACK RECORD OF DEMONSTRATED SAFETY In a field study including 30,201 doses of LymeVax administered to dogs, the vaccine-associated adverse event rate was only 0.44% 1 In a field study involving 4,033 doses of LymeVax, among all vaccinated dogs, only 1.9% experienced minor reactions 2 1 Moore GE, Guptill LF, Ward MP, et al. Adverse events diagnosed within three days of vaccine administration in dogs. JAVMA. 2005;227(7): Levy SA, Lissman BA, Ficke CM. Performance of a Borrelia burgdorferi bacterin in borreliosis-endemic areas. JAVMA. 1993;202(11): Return to Agenda 62

63 63 FELINE PORTFOLIO

64 5 THINGS EVERY VETERINARIAN SHOULD KNOW ABOUT ZOETIS FELINE VACCINES 1 Non-adjuvanted Felocell 3 and Felocell Intranasal, non-adjuvanted Felocell FVR C helps protect healthy cats against feline viral rhinotracheitis caused by feline herpesvirus-1 and feline respiratory disease caused by feline calicivirus Leukocell 2 has all 3 subgroups (A, B, and C) for protection Not all competitive vaccines provide this coverage Leukocell 2 contains FOCMA (feline oncornavirus associated membrane antigen) FOCMA antibodies have been shown to help confer immunity to FeLV-induced lymphosarcoma and aid in successful resistance to tumor development 1 Vaccination Assurance from Zoetis including the Companion Animal Immunization Support Guarantee up to four years for Felocell 3 and up to 2 years for Leukocell 2 1 Essex M. Horizontally and vertically transmitted oncornaviruses of cats. Adv Cancer Res. 1975;21:

65 THE CONFIDENCE OF CLINICAL EVIDENCE FELOCELL VACCINES ARE BACKED BY SEROLOGY DATA GATHERED UNDER THE SAME CONDITIONS THAT YOUR CLIENTS PETS EXPERIENCE EVERY DAY DOCUMENTED BY PEER-REVIEWED DATA AND PUBLISHED IN THE JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION Duration of serologic response to three viral antigens in cats Douglas E. Mouzin, MS, MBA; Marianne J. Lorenzen, DVM; John D. Haworth, DVM, PhD; Vickie L. King, PhD J Am Vet Med Assoc 2004;224:61-66 METHODS 272 client-owned cats from 40 US and Canadian practices cats had no disease history involving the 3 study pathogens Documented history of primary vaccination series and at least 1 revaccination 8-16 months later with Felocell vaccines only On day 0 blood samples were collected and the cats were revaccinated 5-7 days later blood samples were taken again and samples were sent to the Cornell University Veterinary Diagnostics Laboratory (CUVDL) for evaluation Serologic response was measured for 3 key antigens in assays by CUVDL 65

66 DURATION OF SEROLOGIC RESPONSE TO THREE VIRAL ANTIGENS IN CATS 1 In most cats vaccination induced a response that lasted up to and beyond 48 months for all 3 antigens (FPV, FCV, and FHV) An animal was classified a responder if: Antibody levels for a specific antigen were at or above predetermined levels (CUVDL) on day 0 2 OR The antibody level increased 4-fold during the week between vaccination at day 0 and 2 nd blood sample PERCENT RESPONDERS OVER TIME FELINE FELINE SEROLOGIC RESPONSE BY ANTIGEN PERCENTAGE AT 6-MONTH INTERVALS SINCE LAST VACCINATION ANTIGEN OVERALL MONTHS MONTHS MONTHS MONTHS MONTHS MONTHS >48 MONTHS FPV 96.7% 96.3% 100% 96.0% 100% 96.0% 92.3% 93.9% FCV 97.8% 99.1% 100% 96.0% 100% 84.0% 100% 100% FHV 88.2% 84.3% 95.9% 92.0% 94.7% 80.0% 100% 84.8% 1 Mouzin DE, Lorenzen MJ, Haworth JD, et al. Duration of serologic response to three viral antigens in cats. J Am Vet Med Assoc. 2004;224: Cornell University Veterinary Diagnostic Laboratory standards for minimum positive serologic response were SN titers 1:32 for FCV and 1:16 for FHV, and HI titers 1:40 for FPV. 66

67 FELOCELL : DEMONSTRATED PERFORMANCE, ESTABLISHED SAFETY & FLEXIBLE OPTIONS Over 30 years of clinical experience behind a feline vaccine line that helps meet your patients needs Felocell 3 and Felocell 4 are non-adjuvanted vaccines PROTECTION RHINOTRACHEITIS CALICIVIRUS PANLEUKOPENIA Felocell 3 CHLAMYDIA (CHLAMYDOPHILA PSITTACI) FELINE LEUKEMIA Product Felocell FVR C (Intranasal) Felocell P Felocell 4 Leukocell 2 67

68 ZOETIS AND MERIAL PRODUCTS ARE BOTH MODIFIED-LIVE VACCINES (NOT RECOMBINANT) WITH THE SAME ANTIGENS CALICIVIRUS CHLAMYDIA PANLEUKOPENIA RHINOTRACHEITIS Felocell 3 MLV MLV MLV Product Felocell 4 MLV ML MLV MLV PUREVAX Feline 3 MLV MLV MLV PUREVAX Feline 4 MLV ML MLV MLV 68 PUREVAX is a trademark of Merial. Return to Agenda

69 LEUKOCELL 2

70 LEUKOCELL 2 DEMONSTRATED PROTECTION AGAINST FELINE LEUKEMIA DEMONSTRATED SAFETY AND EFFICACY Robust efficacy demonstrated in immunogenicity study required for licensure All cats in the pivotal study were immunosuppressed with corticosteroids and challenged with the highly pathogenic Rickard strain of feline leukemia virus (FeLV) Pivotal immunogenicity study design included intranasal route of challenge to closely resemble natural exposure Randomized cohabitation demonstrated real-world efficacy 1 Latency testing up to 4 years post-challenge could not induce disease 2 1 Pollock RVH, Scarlett JM. Randomized blind trial of a commercial FeLV vaccine. J Am Vet Med Assoc. 1990;196(4): Haffer KN, Sharpee RL, Beckenhauer WH. Feline leukemia vaccine protection against viral latency. Vaccine. 1987;5:

71 LEUKOCELL 2 DEMONSTRATED PROTECTION AGAINST FELINE LEUKEMIA HELPS PROVIDE TUMOR PROTECTION Induces antibodies against FOCMA (feline oncornavirus-associated cell membrane antigen) FOCMA antibodies have been shown to help confer immunity to FeLV-induced lymphosarcoma and aid in successful resistance to tumor development 1 HOW FOCMA ANTIBODIES DESTROY TUMOR CELLS FOCMA Antibody Binds to FOCMA on Tumor Cell FeLV Bud FOCMA Tumor Cell Lysis Antibody Complex Produces Cytotoxic Reaction FOCMA Antibodies 1 Essex M. Horizontally and vertically transmitted oncornaviruses of cats. Adv Cancer Res. 1975;21: Return to Agenda 71

72 72 DEFENSOR

73 DEFENSOR CONTAINS INACTIVATED RABIES VIRUS FROM AN ESTABLISHED CELL LINE TO HELP PROTECT DOGS AND CATS FROM RABIES Contains a highly immunogenic, fixed strain of rabies virus that originated from Louis Pasteur s original 1882 isolate and has been extensively tested Formulated with a chemically inactivated rabies virus prepared from cell culture In a field safety study, with 2,647 doses administered, 96.2% of the doses were administered with no vocalization and 99.9% of doses were administered with no lameness, stiffness, hypersensitivity reactions, or injection site reactions for 21 days after vaccination 1 Defensor vaccines produced for sale in California meet specific potency standards required by that state 1 Data on file, Study Report June 28, 1991, Zoetis Inc. Return to Agenda 73

74 74 VACCINATION ASSURANCE FROM ZOETIS

75 Zoetis will cover reasonable diagnostic and treatment costs up to $5,000 if a pet vaccinated with one of the Zoetis antigens listed below contracts the corresponding disease after January 1, 2016 Conditions: The pet must be vaccinated by a licensed veterinarian with an established client-patient relationship. A veterinarian (or appropriate veterinary health care team member) must be the primary point of contact for the guarantee to be valid. Zoetis will direct all claims from pet owners, breeders, etc., to the vaccinating veterinarian. At the time of a claim, veterinarians must collaborate with Zoetis Veterinary Medical Information and Product Support (VMIPS) in designing an appropriate diagnostic and treatment regimen. A diagnosis must be made using criteria predetermined by VMIPS. To contact VMIPS, call At the time of a claim, veterinarians must submit a copy of medical records pertinent to EACH reported case, including vaccine brand, serial number and date of vaccination. At the time of a claim, vaccine purchase history will be verified by VMIPS. Claims involving vaccines purchased from unauthorized sources will not be supported under the Zoetis Companion Animal Immunization Support Guarantee. Claims involving animal species other than those on the product label are not covered. Claims involving puppies and kittens less than 15 weeks of age, or involving onset of disease within 3 weeks (2 weeks for Canine Influenza Virus) of completing the initial immunization series, are not covered.

76 Conditions (continued): For the core vaccine Companion Animal Immunization Support Guarantee (4 years) to be valid, the pet must have received an age-appropriate initial vaccination series as per the vaccine label. A Zoetis vaccine must be the most recent vaccine used in the series. Per AAHA/AAFP Vaccination Guidelines, a 1-year booster is recommended after the initial puppy/kitten series. When a series is required, the two vaccines should ideally be given according to the label instructions, but no sooner than 2 and no greater than 6 weeks apart. For the non-core vaccine Companion Animal Immunization Support Guarantee (1 year) to be valid, the pet must have completed an age-appropriate vaccination series as per the vaccine label. A Zoetis vaccine must be the most recent vaccine used in the series. Any animal vaccinated in accordance with the AAHA/AAFP Vaccination Guidelines, with appropriate Zoetis vaccines, is fully covered under the Zoetis Companion Animal Immunization Support Guarantee. For the Feline Leukemia support guarantee (2 years) to be valid, the medical record must document a negative FeLV test at the time of immunization. All payments made under the Zoetis Companion Animal Immunization Support Program may require a signed consent form from the veterinarian and/or pet owner.

77 Bordetella bronchiseptica Vaccines: Animals will be covered under the Companion Animal ISG for any Zoetis Bordetella bronchiseptica vaccine as long as exposure has not occurred for 1 week following completion of the vaccination series or mucosal vaccine. Zoetis is proud to support dogs who are suspected to have a Bordetella bronchiseptica infection for diagnostic and treatment (if they are in fact diagnosed) costs up to $7,500 if they have received a prime boost protocol. This protocol entails the use of a Zoetis B. bronchiseptica intranasal vaccine as the initial or priming dose. In 2-6 weeks, the dog will receive a "booster" dose of Bronchicine CAe. Thereafter, the dog will receive an annual injection of Bronchicine CAe. 1 YEAR 15* MONTHS 2 YEARS 3+1 YEARS of coverage for: Borrelia burgdorferi Bordetella bronchiseptica Canine Coronavirus Chlamydophila felis (Chlamydia psittaci) Canine Influenza Virus of coverage for: Leptospira icterohaemorrhagiae L. canicola L. grippotyphosa L. pomona * 15 month coverage applies after an appropriate initial series and a timely 1 year booster. of coverage for: Feline Leukemia Virus of coverage for: Canine Distemper Virus Canine Parvovirus Canine Parainfluenza Virus Canine Adenovirus-1&2 Feline Parvovirus (Feline Panleukopenia) Feline Herpesvirus-1 Feline Calicivirus

78 POWER FAILURE PROTECTION We realize vaccines are a significant investment for your practice If a power failure affects Zoetis companion animal vaccines in your refrigerators, contact your Zoetis territory business manager or customer service representative to request a complimentary replacement of vaccines* * Zoetis reserves the right to review claims on a case-by-case basis, and will require the return of inactivated/warmed vaccines. 78

79 VETERINARY MEDICAL INFORMATION AND PRODUCT SUPPORT (VMIPS) We offer the on-call support of a professional team of veterinarians, veterinary technicians, technical service specialists and outcomes researchers with extensive veterinary practice experience and product knowledge.* * You can contact VMIPS at Monday through Friday from 9:00 a.m. to 8:00 p.m. ET. 79

80 ADDITIONAL SUPPORT PRODUCTS AND SERVICES We support you with continuing education (CE) programs, high quality syringes with a minimum purchase, client brochures, posters, reminder cards, vaccination certificates, health records, rabies tags, complimentary diluent, a generous return program and the option of Saturday deliveries.* * Orders must be placed before 4:00 p.m. ET on Friday. Additional delivery fees apply and are contingent on carrier/area availability. 80

81 OUR COMMITMENT GOES BEYOND THE VACCINE LEARN MORE ABOUT ZOETIS VACCINATION ASSURANCE Please call 888-Zoetis1 ( ) or contact your territory business manager. All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted Zoetis Services LLC. All rights reserved. SAB Return to Agenda 81