discover the nextgeneration of flea & tick protection NEW TASTY CHEW ONE CHEW ONCE A MONTH

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1 discover the nextgeneration of flea & tick protection KILLS FLEAS KILLS TICKS ONE CHEW ONCE A MONTH TASTY CHEW NEW

2 Now there s a new oral treatment that offers effective flea AND tick control on dogs for a full month. Containing a powerful new active ingredient developed specifically for companion animals, NEXGARD Chewables for Dogs provide effective protection against fleas and ticks, including Paralysis ticks, in an easy to administer beef-flavoured chew. It s as simple as one chew, once a month, for monthly protection against fleas and ticks. NEXGARD (afoxolaner) Soft, beef-flavoured chew that dogs readily accept. 1 Rapidly kills fleas. 2 Kills Ticks I.holocyclus, R. sanguineus and H. longicornis. 3,4,5,6 Month-long protection against ticks and fleas. Can be given with or without food. Suitable for puppies (from 8 weeks), all breeds of dog, and for dogs and puppies from 2kg in weight. Not affected by bathing, swimming or shampooing. No need to separate treated dogs from other pets in household. Excellent Merial Technical Support.

3 introducing afoxolaner Next-Generation Science Afoxolaner is a new molecule developed specifically for the control of fleas and ticks on dogs.7 Afoxolaner kills fleas and ticks by selectively binding to GABA-gated and glutamate-gated chloride channels in insect and acarine nerve cell membranes. 8 This blocks the flow of chloride ions across nerve cell membranes and produces a state of hyperexcitation resulting in uncontrolled activity of the central nervous system (CNS) and death. The target site within these nerve channels is distinct from the site targeted by other insecticide classes.7 Furthermore, the target sites in the nerve channels of fleas and ticks differ from those found in mammals, allowing for selective targeting within invertebrates. F3C F3C O N H O N Cl N O CF3 H Afoxolaner is fast acting and long lasting due to its pharmacokinetic profile: Rapidly absorbed into the bloodstream, reaching peak plasma levels in 2-6 hours.9 Absorption of afoxolaner is not affected by the prandial state of the dog, meaning that it can be given with or without food.9 Terminal half-life of approximately 15 days allows it to maintain an effective plasma concentration for the full month.9 Predictable pharmacokinetics with studies showing no significant variation in absorption, metabolism or elimination regardless of breed or age.9 Concentration of Afoxolaner versus Time in Fed and Fasted Dogs1 Concentration (ng/ml) 1, Fasted Fed 1, Time (days) 28 35

4 proven flea efficacy NEXGARD controls fleas within 8 hours of administration. One controlled study demonstrated 1% mortality of fleas within 6 hours of administration. 12 NEXGARD has demonstrated rapid control of fleas for a full month. NEXGARD is indicated for the treatment and prevention of flea infestations and for the control of newly acquired adult fleas. Two studies have examined the efficacy of NEXGARD throughout the month and have demonstrated >95% mortality of fleas within 12 hours for 3 weeks and >.9% mortality of fleas within 24 hours for 5 weeks (following weekly flea infestations) % % 1 1 % %.9% 1 % 1 1 % % 1 %.9% % 3% Fleas are obligate ectoparasites and can commence egg-laying on the host hours after the first blood meal. 11 Efficacy of NEXGARD against C.felis at 24hrs13,14 1 Geometric mean % efficacy An optimal flea control program should include both the rapid elimination of established flea infestations and the provision of long lasting protection from ongoing flea challenges. Australian Assessment The results of the above studies are consistent with the Australian local study data. There were two Australian studies conducted against Ctenocephalides felis under controlled conditions.13,14 In both studies, 1% fleas were killed within 24 hours of administering NEXGARD, and efficacy was maintained.9% for 4 weeks post administration Days 29 Flea Study 1 Flea Study 2 NEXGARD works in the real world too! All dogs had flea counts performed prior to administration of NEXGARD, and initial flea burdens varied from 11 to over 11 fleas. Monthly flea counts were conducted and efficacy was calculated by comparing the flea count at a given time point with the baseline flea count on the same dog at Day. Mean efficacy (group) of NEXGARD was % reduction in flea counts at each time point for the duration of the study. These results are in line with the results of a US field study of 186 households, in which treatment with NEXGARD reduced the flea counts on dogs by.9% over the course of 3 months, following monthly treatment Days 9 1 %.9% Dogs in households from NSW (n=14) and QLD (n=11) were treated with NEXGARD at monthly intervals for 3 months. 1 % Australian Field Study1 : Efficacy against C.felis in Australian field conditions1 Geometric mean % efficacy In addition to studying the efficacy of NEXGARD under controlled conditions, field trials have been undertaken to assess the efficacy of NEXGARD in both Australia and the USA. Field studies demonstrate how a flea product works in real world conditions where dogs may be exposed to newly emerged fleas from environments contaminated with flea eggs, larvae and pupae

5 Long-Lasting Tick Protection Geometric mean % efficacy 1.2 %.4% 1 %.4%.1 %.7%.7 98 %.7%.7 %.7%.7 1 % % Efficacy of NEXGARD against I.holocyclus at 48hrs 3,4 Market research into consumer behaviour has highlighted the considerable confusion that exists among pet owners in regards to tick protection. For example, 82% of dog owners who live in Paralysis tick areas are not treating correctly to protect their dogs from the deadly Paralysis tick.16 NEXGARD provides effective monthly protection against fleas AND ticks, including deadly Paralysis ticks, distilled in a tasty chew. NEXGARD s one chew, once a month format simplifies flea and tick treatment, leading to a dosing regimen that is regular and easy to follow for pet owners. Greater convenience for pet owners and an appealing treat for dogs, NEXGARD is the simple solution for flea and tick control for your clients There are a number of species of ticks that dogs in Australia can be exposed to. These ticks can cause a variety of diseases ranging from skin irritation to anaemia, to tick paralysis. Some tick species can act as vectors for diseases such as babesiosis Days 3 37 Paralysis Tick Study 1 Paralysis Tick Study 2 Paralysis tick, Ixodes holocyclus, a unique Australian parasite Ixodes holocyclus is present along the east coast of Australia and poses a serious health risk to dogs. Each year thousands of dogs present to veterinary hospitals with signs of tick paralysis caused by this parasite.17 Two Australian studies were performed to assess the efficacy of NEXGARD against this potentially deadly parasite. 3,4 In each study, 5 ticks were infested onto each dog on day 1, 7, 14, 21, 28 and 35. Geometric mean % efficacy 96.4% 95.7%.4%.3% 98.1% % Efficacy of NEXGARD against R.sangineus at 48hrs 5 NEXGARD was administered on day. Tick counts were conducted on Days 1,2,3 (24, 48 and 72 hours after administration of NEXGARD ) and thereafter at 24, 48 and 72 hours post each subsequent tick infestation. 8 In both studies, there was significant mortality of ticks within 24 hours at all time-points and >98.5% of ticks were killed within 48 hours after NEXGARD administration and weekly infestations. 6 Other tick species 4 The efficacy of NEXGARD has also been assessed against two other tick species commonly found in Australia. 2 A study assessing the efficacy of NEXGARD against Brown Dog ticks ( Rhipicephalus sangineus) in Australia, showed that NEXGARD achieved >95% efficacy at 48 hours post-treatment and postinfestation for 5 weeks after treatment Days 3 37 A study assessing the efficacy of NEXGARD against Bush ticks ( Haemaphysalis longicornis) in Japan, showed that NEXGARD achieved >95% efficacy by 72 hours post-treatment.6

6 Designed to be safe, Proven to be safe Before developing the final formulation of NEXGARD, numerous studies were conducted with an experimental oral solution of afoxolaner during which all dogs were evaluated for adverse reactions.7 The results of these studies confirmed the potential for afoxolaner as a safe ectoparasiticide and led the way to additional target animal safety studies using the final formulation of the product. A margin of safety study was conducted in healthy puppies as young as 8 weeks of age. 18 NEXGARD was administered at approximately 1x, 3x and 5x the exposure dose of 6.3mg/kg for 3 monthly treatments followed by 3 fortnightly treatments. NEXGARD was well tolerated throughout the study period. A total of six studies were conducted on dogs in Australia confirming the efficacy and safety of NEXGARD against fleas and ticks. There were no treatment related adverse events seen in any of these studies including in the field trial conducted in real homes across Australia. 1,3,4,5,13,14 Safety data from a large scale US field study involving 415 dogs treated with NEXGARD and 2 dogs treated with Comfortis (spinosad) showed that the most frequently reported adverse event in both groups was vomiting, which tended to be self-limiting and of short duration. 15 The incidence of vomiting was 3x higher in the spinosad-treated group. Use with other medications: Safety in Collie breeds: Afoxolaner was well tolerated in Collies with a deficient multidrugresistance-protein 1 (MDR1-/-) following single oral administration at 1 times the recommended dose.19 Breeding, Pregnancy and Lactation: Studies with NEXGARD have not been conducted in pregnant and lactating female dogs. Incidence of vomiting in US field trial15 14 % of dogs in treatment group In the Australian and US field trials, NEXGARD was given to dogs that were being treated with other medications such as vaccines, anthelmintics, antibiotics (including topicals), steroids, NSAIDS, anaesthetics and antihistamines. No adverse reactions were observed from the concomitant use of NEXGARD with these medications. 1, % % 2 NEXGARD Comfortis

7 Flea & tick protection never tasted so good NEXGARD tasty chews are designed for ease of administration. Created with soy protein and braised beef flavouring, NEXGARD is a treat that your dog will love. Superior Palatability In two studies, of dogs that showed a preference, 19-1 preferred NEXGARD over Comfortis. 2 NEXGARD Dogs COMFORTIS 1 Dog Simplified dosing can be given with or without food Studies show that there is no significant difference in plasma levels of afoxolaner between fed and fasted dogs.9 This means that, unlike Comfortis, there is no need to administer NEXGARD with food. Dogs can take NEXGARD as a monthly treat, whether it is dinnertime or not. The NEXGARD Range NEXGARD is available in 4 weight ranges: Chew Size Active Ingredient Dog Weight Range Afoxolaner Dosing Range.5g chew 11.3mg afoxolaner 2-4kg mg/kg 1.25g chew 28.3mg afoxolaner 4.1-1kg mg/kg 3g chew 68mg afoxolaner kg mg/kg 6g chew 136mg afoxolaner kg mg/kg

8 NEW For more product information, contact Merial Customer Solutions on See NEXGARD product label for full claim details References 1. Merial data on file: PR&D Hunter III et al (214) Evaluation of the curative and preventative ef ficacy of a single oral administration of afoxolaner against cat flea Ctenocephalides felis infestations on dogs Vet Parasitology 21: Merial data on file: PR&D Merial data on file: PR&D Merial data on file: PR&D Kondo et al (214) Evaluation of the ef ficacy of afoxolaner against Haemaphysalis longicornis on dogs Vet Parasitology 21: Shoop et al (214) Discovery and mode of action of afoxolaner, a new isoxazoline parasiticide for dogs Vet Parasitology 21: Garcia-Reynaga et al (213) New GABA/Glutamate receptor target for [3H] isoxazoline insecticide Chem Res Toxicol 26: Letendre et al (214) The intravenous and oral pharmacokinetics of afoxolaner used as a monthly chewable antiparasitic for dogs Vet Parasitology 21: Merial data on file: PR&D Kramer & Menke (21) Flea Biology and Control 12. Beugnet et al (214) Afoxolaner against fleas: immediate ef ficacy and resultant mortality after short exposure on dogs Parasite 21: Merial data on file: PR&D Merial data on file: PR&D Freedom of Information Summary, NADA , NEXGARD 16. IPSOS Brand Tracking Data Feb Brazier et al (214) The association between landscape and climate and reported cases of tick paralysis in dogs and cats Vet Parasitology (214) 24: Drag et al (214) Safety evaluations of orally administered afoxolaner in 8-week old dogs Vet Parasitology 21: EMA (213) CVMP Assessment Report for NEXGARD 2. Merial Data on File: VS-USA-7241, VS-USA-7242 NEXGARD is a registered Trade Mark of Merial. 214 Merial Limited. All Rights reserved. NXG