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NEW 1 Tasty Chew. 3 MONTHS PROTECTION. * PROTECTION EXTEND YOUR PARALYSIS TICK AND FLEA *Refer to label for full claim details. 4 MONTHS AGAINST PARALYSIS TICKS 3 MONTHS AGAINST FLEAS

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Page 1: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

NEW

1 Tasty Chew. 3 MONTHS PROTECTION.*

PROTECTION

EXTEND YOURPARALYSIS TICK AND FLEA

*Refer to label for full claim details.

4 MONTHS AGAINST PARALYSIS TICKS

3 MONTHS AGAINST FLEAS

Page 2: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto
Page 3: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

FLEA AND TICK MANAGEMENT MAYBE A CHALLENGE FOR DOG OWNERS

FLEA AND TICK TREATMENT COMPLIANCE AMONGST DOG OWNERS

4% 4%

39% 34%

31%

28%

13%

12%

6%

9%

4%7%

3% 6%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Flea Tick

Never Less often Annually Every 6 months

Every 3 months Every month Fortnightly

57% of owners treat their dog for fleas every 3

months or less frequently1

62% of owners treat their dog for ticks every 3 months

or less frequently1

NOW IS THE TIME FOR A SMART NEW SOLUTION.

• Monthly and fortnightly treatments require diligent reapplication.

• Inconsistently applied treatments can leave dogs vulnerable to parasite risks.

• The majority of dog owners only treat for fleas and ticks every 3 months or less frequently.1

• Protection gaps can lead to reinfestation.

• Topically applied products may wash or rub o�.

Per

cent

age

of d

og o

wne

rs t

reat

ing

at v

ario

us f

requ

enci

es (n

= 1

,00

9)

Page 4: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

UNIQUE MODE OF ACTION

• Fluralaner is a potent inhibitor of parts of the arthropod nervous system.2,3

• It acts antagonistically on two di�erent ligand-gated chloride channels (GABA-receptor and glutamate-receptor).2

• Fluralaner has selective inhibitory activity on insecticidal/acaricidal targets.3

- Fluralaner has less pronounced activity on the tested mammalian GABA-receptor indicating a high safety margin.4

- Inhibitory glutamate-gated chloride channels exist in arthropods, not in mammals.3

NOT IMPACTED BY KNOWN RESISTANCES

• studies show high e�cacy against flea strains which are resistant to several classes of ectoparasiticides including the phenyl pyrazole class (e.g. fipronil).2,4,5

• An study also showed Bravecto is e�ective against fipronil-resistant strains of fleas.4

• In a recent study, fluralaner also exhibited higher parasiticidal activity compared with fipronil, imidacloprid and other agents with di�erent modes of action.2

EXCLUSIVE TO ANIMAL HEALTH

• Developed specifically for veterinary use and has not been used in crop protection.

INTRODUCING NEW BRAVECTO A QUANTUM LEAP FORWARD IN PET SCIENCE

BRAVECTO (FLURALANER) IS A MEMBER OF THE ISOXAZOLINE CLASS OF PARASITICIDES - A NEW, INNOVATIVE CLASS

In vitro

in vitro

in vivo

Page 5: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

UNIQUE PHARMACOKINETICS

TIME (DAYS)

PHARMACOKINETIC CURVE6

0

100

10

1

1000

10000

14 28 48 56 70 84 98 112

FLU

RA

LAN

ER P

LASM

A C

ON

CEN

TRAT

ION

( ng

/mL)

• Oral administration of fluralaner achieves rapid anti-parasitic activity and has extended duration.

- Rapid absorption (Tmax - 1 day).6

- Long elimination half-life (T½ 12-15 days).6

- Quantifiable plasma concentrations for ≥ 12 weeks.6

- High distribution to tissues and low clearance, explains the long-lasting systemic availability of fluralaner in dogs.6

- No major metabolism and excretion mainly via faeces.5

- Feeding increases the bioavailability of fluralaner.7

Plasma concentrations of fluralaner in dogs following a single oral administration (25mg/kg BW)

Page 6: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

• Treatment and prevention of flea (Ctenocephalides felis) infestations for three months.

• Treatment and control of paralysis tick (Ixodes holocyclus) for four months.

• Treatment and control of brown dog tick (Rhipicephalus sanguineus) for eight weeks.

EXTENDED PROTECTION

BRAVECTO DELIVERS CONSISTENT AND LONG-LASTING EFFICACY AGAINST BOTH FLEAS AND TICKS FROM A SINGLE TASTY CHEW.4,11,12

• Reasearch indicates most pet owners don’t use insecticides year-round.1

• Flea and tick treatments are often applied infrequently by dog owners, with some treating only every 3 months or less.1,9,10

• Once a flea infestation has been established it can take up to 8 or more weeks to eradicate it.8

• The Bravecto treatment program means dog owners have little to think about and less to remember, when protecting against fleas and paralysis ticks.

Page 7: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

RAPID AND CONSISTENT FLEA EFFICACY4,13

• Provides e�ective control within 8 hours after treatment.4,13

• Continues to e�ectively kill newly arriving fleas within 8 hours of infestation, throughout the entire 3 month treatment interval.4,13

• Rapid onset of action kills newly emerged adult fleas before they lay eggs.

- An study has demonstrated that very low concentrations of fluralaner have been shown to stop the production of viable eggs by fleas.4,14

A field study4 conducted in South East Queensland, during the active flea season included 23 dogs of various breeds and weights from 17 households. The arithmetic mean flea count was 64 (range 9-259). No other insecticides on the pet or in the environment were allowed.

A single treatment with Bravecto on visit 1 (day 0) achieved 100% e�cacy at 4 weeks post-treatment. This was maintained until the end of the study, at 12 weeks post-treatment.

PROVEN PERFORMANCE IN AUSTRALIAN CONDITIONS4

An Australian pen study4 assessing the performance of Bravecto to e�ectively control artificial infestations of adult cat fleas on dogs, displayed ≥ 99.9% e�cacy throughout the 3 month trial.

3 10 17 24 31 45 59 73 87

PEN STUDY - FLEA EFFICACY(% reduction versus control)

% E

�ca

cy

Day

100

80

60

40

20

0

99

.9

99

.9

99

.9

10

0

10

0

10

0

99

.9

10

0

10

0

FIELD STUDY - FLEA COUNTS

4 weeks 8 weeks 12 weeks

70

60

50

40

30

20

10

0Pre-

treatmentN

umbe

r of

fleas

(arit

hmet

ic m

ean)

in vitro

Page 8: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

CONSISTENTLY MORE FLEA FREEDOGS SEEN WITH BRAVECTO

Comfortis + Preventic

Bravecto

100%

80%

60%

40%

20%

0%

91

.1%

95

.4%

95

.3%

84

.4%

88

.2%

44

.7%

In a US field study12 of 157 households with 294 client owned dogs in which flea control was assessed, pet dogs received either one dose of Bravecto (25-56mg/kg fluralaner) or three monthly doses of Comfortis® (30-60mg/kg spinosad) combined with a Preventic® (9% amitraz) collar.

FLEA CONTROL WITH BRAVECTOVS COMFORTIS + PREVENTIC

BRAVECTO% FLEA REDUCTION

CONTROL GROUPCOMFORTIS + PREVENTIC

% FLEA REDUCTION

WEEK 4 99.7 96.1WEEK 8 99.8 99.5WEEK 12 99.8 99.6

A randomised, blinded, multi-site European field study11, compared the e�cacy of a single oral dose of Bravecto with three sequential topical treatments of fipronil at four week intervals.

The proportion of flea-free households in the Bravecto group was significantly superior to the fipronil-treated households at all time points.

WEEK 2 WEEK 4 WEEK 8 WEEK 12

100%

80%

60%

40%

20%

0%

% FLEA-FREE HOUSEHOLDS** OVER 12 WEEKS

*

*

*

**

*

Fipronil (n=61)

Bravecto (n=115)

*p<0.0001 vs Fipronil

**Households = households withALL dogs in the household recordedas flea-free.

Note: Fipronil reapplied on day 28 andagain on day 56, per EU label claim.

*statistically significant

® Comfortis is a registered trademark of Elanco. Preventic is a registered trademark of Virbac.

EUROPEAN AND US FIELD STUDIES11,12

ONE DOSE DOES WHAT SOME OTHER PRODUCTS DO WITH THREE

WEEK 4 WEEK 8 WEEK 12

Per

cent

age

flea

fre

e ho

useh

olds

Per

cent

age

of fl

ea f

ree

dogs

62

.3%

63

.9%

94

.9%

70

.5%

95

.7%

82

.0%

97.

4%

89

.6%

Page 9: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

BRAVECTO REDUCES THE INCIDENCEOF FLEA ALLERGY DERMATITIS (FAD)4,11,12

*Canine Atopic Dermatitis, Extent and Severity Index

• Australian, US and European field studies demonstrated that one dose of Bravecto provided substantial reduction in clinical signs of flea allergy dermatitis.4,11,12

• Additionally, Bravecto was used in an Australian dermatologist-run study4 with 20 client-owned dogs, where no additional flea or flea premise products, corticosteroids or antihistamines were used.

- At Week 4, only one flea was found on one of the enrolled dogs.

- No fleas were found on any dogs at the Week 8 and Week 12 flea counts.

- At week 12, after 1 administration of Bravecto, all dogs were flea free and there was 100% resolution of FAD. CADESI and pruritus scores were also significantly reduced.

WEEK 1 WEEK 12 WEEK 1 WEEK 12

100%flea free

100% FADresolution

94.5%reductionin pruritus

96.3%reductionin CADESI*

score

Page 10: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

• Toxin secretion from ticks has a specific timing during the engorgement process and is associated with major physiological changes in tick salivary glands occurring on the third day.15,16

• Laboratory dogs infested with 3 to 4 ticks had an onset of clinical signs of toxicity between 5.5 and 7 days (mean = 6.2 days) with death occurring in a mean of 23.3 hours after the onset of signs.17

• Therefore, to prevent the occurrence of fatal paralysis in tick infested dogs, it is critical to kill the ticks within 72 hours post infestation and prior to the onset of clinical signs.

TREATS AND CONTROLS PARALYSIS TICKFOR 4 MONTHS4

• Bravecto provides e�ective control of pre-existing paralysis ticks (Ixodes holocyclus) within 24 hours of treatment.4

• Bravecto also controls brown dog tick (Rhipicephalus sanguineus) for 8 weeks.

• In tick season daily searching for and removal of any ticks found is recommended.

• Due to the systemic nature of action of Bravecto, dead attached ticks can still be seen on animals following treatment. These ticks will often appear partially engorged. Dead ticks can be easily removed as opposed to live ticks which take some force to dislodge from the skin of the animals.

LIVE ATTACHEDENGORGED TICK

DEAD ATTACHEDUNENGORGED

Ixodes holocyclus

Page 11: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

• Fluralaner e�cacy against was >99.2 % at 48 hours and 100% at 72 hours after tick infestation at all time-points post treatment, for 115 days delivering unmatched, extended protection in dogs against paralysis ticks from a single oral treatment.

• The di�erences between mean live tick counts on treatment and control groups were significant (P < 0.00l) at all assessment time points.

TREATS AND CONTROLS PARALYSIS TICKFOR 4 MONTHS4

• In an Australian study4, 24 healthy Foxhound and Foxhound cross dogs immunized against holocyclotoxin were randomly allocated to receive Bravecto treatment or no treatment.

• All dogs were penned individually and 30 adult unfed female were individually attached 1 day before treatment and 14, 28, 42, 56, 70, 84, 112 and 140 days following treatment.

• Ticks were counted and assessed at 24, 48 and 72 hours after the initial treatment and after each subsequent infestation.

• Ticks were not removed at the 24 and 48 hour assessments, but were removed after the 72 hour assessments.

BRAVECTO

E�ca

cy %

(Mea

n To

L)

- 1 1 2 3 14 15 16 17 28 29 30 31 42 43 44 45 56 57 58 59 70 71 72 73 84 85 86 87112

113114

115140

141142

143

100.

0

100.

0

99.6

100.

0

99.6

100.

0

100.

0

97.0

100.

0

100.

0

99.6

100.

0

100.

0

99.2

100.

0

100.

0

99.6

99.2

100.

0

99.2

99.2

100.

0

45.4

78.0

95.7

100.090.080.070.060.050.040.030.020.010.0

0.0

Paralysis tickre-treatment

period

Study Day

87.1

99.6

100.

0

Ixodes holocyclus

Ixodes holocyclus

Page 12: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

REASSURANCE FOR YOU AND YOUR CUSTOMERS

• Bravecto can be used in puppies from 8 weeks of age weighing greater than 2kg.

• Bravecto has been shown to be well tolerated in puppies when tested at up to 5X the highest recommended treatment dose (280 mg fluralaner/kg BW) on 3 occasions at 8-weeks intervals.4,18

• Bravecto can be used in breeding, pregnant and lactating dogs.

• Bravecto is well tolerated in MDR1 gene deficient collies. Following a single administration at 3 times the highest recommended treatment dose in clinical use (168 mg/kg BW), no treatment–related clinical signs were observed.19

• During clinical field testing, no interactions between Bravecto and routinely used medicinal products were observed.4,11,12

• In the US field trial the most common adverse event in the Bravecto treated group was vomiting, seen in a small number of dogs (7.1%) over a 26 week period, compared with 14.3% over a 12 week period in the oral Comfortis plus Preventic collar treated control group.12 In the EU field study, adverse events were limited to mild and transient gastrointestinal signs such as diarrhoea and vomiting in 1% of Bravecto treated dogs. 2.3% of Frontline treated dogs had primarily dermal adverse events.11

Page 13: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

EASY TO GIVE, LESS TO THINK ABOUT

• A highly palatable, easy to administer chew - studies show more than 91.7% of dogs accept Bravecto voluntarily.4,12

• Bravecto's extended protection periods* mean clients have few treatments to remember each year, therefore less to forget.

• No mess to administer, no liquids to spill or transfer.

• Full year flea protection in just four tasty doses - protection at every season. Fits easily into gastrointestinal worming programs where treatments occur every 3 months.

1 Tasty Chew. 3 MONTHS PROTECTION.*

*3 months protection against fleas, 4 months protection against paralysis ticks and 8 weeks protection against brown dog ticks. Refer to label for full claim details.

Bravecto is ideal for active dogs with a love of swimming, or dogs with skin conditions that require frequent bathing, due to its systemic activity.

Page 14: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

SIMPLE DOSING FOR INCREASED CONVENIENCE

EASY TO MERCHANDISE IN SINGLE DOSE PACKS

• Within each weight range, a whole tablet must be used. For dogs weighing more than 56kg use a combination of tablets that most closely matches the bodyweight.

• Administer Bravecto at or around the time of feeding for maximum bioavailability.7

• In dogs older than 8 weeks, treatment every 8 weeks has been shown to be well tolerated.

Bodyweightof dog

(kg)

2 - 4.5

>4.5 - 10

>10-20

>20-40

>40-56

Just one tasty chew for 2 to 56 kg

BRAVECTO®112.5 mg

BRAVECTO®250 mg

BRAVECTO®500 mg

BRAVECTO®1000 mg

BRAVECTO®1400 mg

1

1

1

1

1

Page 15: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto
Page 16: PARALYSIS TICK AND FLEA PROTECTION - · PDF file*Canine Atopic Dermatitis, Extent and Severity Index • Australian, US and European field studies demonstrated that one dose of Bravecto

NEW

THE ONLY ORAL CHEW TO DELIVER 3 MONTHS FLEA AND

4 MONTHS PARALYSIS TICK PROTECTION FOR DOGS IN A SINGLE DOSE.

For further information or to order Bravecto® contact your MSD Animal Health representative or call the Bravecto Hotline on 1800 230 833.

1. Project Hound Market Research Study, MSD Animal Health 2014. 2. Gassel M, Wolf C, Noack S, Williams H, Ilg T. The novel isoxazoline ectoparasiticide �uralaner: elective inhibition of arthropod g-aminobutyric acid- and L-glutamate-gated chloride channels and insecticidal/acaricidal activity. Insect Biochem Mol Biol. (2014) 45:111-124. 3. Ozoe Y, Asahi M, Ozoe F, Nakahira K and Mita T. The antiparasitic isoxazoline A1443 is a potent blocker of ligand-gated chloride channels. Biochemical and Biophysical Research Communications (2010) 391:744-749. 4. MSD data on �le 5. Bravecto EPAR Summary of Product Characteristics MA No. EU/2/13/158/001-015, 11/02/2014. 6. Klip S, Ramirez D, Allan MJ, Roepke R and Nuernberger MC. Pharmacokinetics of �uralaner in dogs following a single oral or intravenous administration. Parasites & Vectors (2014) 7:85. 7. Walter FM, Allan MJ, Roepke R and Nuernberger MC. The e�ect of food on the pharmacokinetics of oral �uralaner in dogs. Parasites & Vectors (2014) 7:84. 8. Ross DH, Arthur, et al. Evaluation of the e�cacy of topically administered imidacloprid + pyriproxyfen and orally administered spinosad against cat �eas (Ctenocephalides felis): Impact of treated dogs on �ea life stages in a simulated home environment. Parasites & Vectors (2012), 5:192. 9. Beck S, Schein E et al. Tick infestation and tick prophylaxis in dogs in the area of Berlin/Brandenburg - results of a questionnaire study. Berliner und Mϋnchener Tieraztliche Wochenschrift 126, Heft 1/2 (2013), Seiten 69-76. 10. Atwell RB, Campbell FE, Evans EA. Prospective survey of tick paralysis in dogs. Aust Vet J (2001) 79:412–418. 11. Rohdich N, Roepke R, Zchiesche E. A randomized, blinded, controlled and multi-centered �eld study comparing the e�cacy and safety of BravectoTM (�uralaner) against FrontlineTM (�pronil) in �ea- and tick-infested dogs. Parasites & Vectors 2014 7:83. 12. Meadows C, Geurino F and Sun F. A randomized, blinded, controlled USA �eld study to assess the use of �uralaner tablets in controlling canine �ea infestations. Parasites & Vectors (2014) 7:375. 13. Taenzler J, Wengenmayer C et al. Onset of activity of �uralaner (BravetcoTM) against Ctenocephalides felis on dogs. Parasites & Vectors (2014) 7:567. 14. Williams HW, Young DR, Qureshi T et al. Fluralaner, a novel isoxazoline, prevents �ea (Ctenocephalides felis) reproduction in vitro and in a simulated home environment. Parasites & Vectors (2014), 7:275. 15. Goodrich BS and Murray MD. Factors in�uencing the toxicity of salivary gland extracts of Ixodes holocyclus Neumann. lnt J Parasitol (1977). 8: 313-320. 16. Masina, S and Broady, K.W. Tick paralysis: development of a vaccine Int. J. Parasitol (1999) 29, 535–541. 17. llkiw JE, Turner DM, and Howlett CR. Infestation in the dog of the paralysis tick Ixodes holocyclus. Clinical and histological �ndings. Aust Vet J (1987) 64: 137-139. 18. Walther, Allan et al. Safety of �uralaner chewable tablets (Bravecto™), a novel systemic antiparasitic drug, in dogs after oral administration. Parasites & Vectors (2014) 7:87. 19. Walther FM, Allan AJ, Allam MJ et al. Safety of �uralaner, a novel systemic antiparasitic drug, in MDRI(-/-) Collies after oral administration. Parasites & Vectors (2014) 7:86.Intervet Australia Pty Limited trading as MSD Animal Health ABN 79 008 467 034. Toll free: 1800 033 461. www-msd-animal-health.com.au AU/BRV/0215/0004