Zoetis Receives FDA Approval for Simparica Trio™, A New Combination Parasite Preventative for Dogs

Zoetis today announced that the U.S. Food and Drug Administration (FDA) has approved Simparica Trio^TM (sarolaner, moxidectin, and pyrantel chewable tablets), the first once-monthly, chewable tablet in the U.S. that delivers all-in-one protection from heartworm disease, ticks and fleas, roundworms and hookworms. This combination product builds on the trusted legacy of Simparica^® (sarolaner) Chewables and exemplifies Zoetis’ dedication to innovation in parasiticides.

“Today’s approval of Simparica Trio in the United States provides veterinarians with a new and effective combination parasiticide for dogs,” said Catherine A. Knupp, DVM, MS, Executive Vice President and President, Research and Development at Zoetis. “Combining the active ingredients sarolaner, moxidectin and pyrantel delivers a convenient broad-spectrum option for veterinarians to provide to dog owners. This innovation was developed by a global team of Zoetis scientists and continues our commitment to deliver new medicines that are needed by our veterinary customers and the pets in their care.”

Studies that support the approval of Simparica Trio showed:

• 100% efficacy in preventing the development of heartworm disease.
• ≥98.9% effectiveness against existing tick infestations ^‡.
• Onset of kill for fleas at four hours and demonstrated 100% efficacy at eight hours after initial administration.
• Efficacy against adult hookworms (>94%)⁺ and adult roundworms (>99%)⁺⁺.

“Comprehensive parasite protection is a critical component of every annual wellness exam, and veterinarians should strongly recommend year-round, broad-spectrum protection for all patients,” said Chris Adolph, DVM, MS, Diplomate ACVM (Parasitology), Senior Veterinary Specialist at Zoetis. “Simparica Trio makes it easier for dog owners to follow their veterinarians’ recommendations for parasite protection because it covers the most common parasites in just one convenient chewable.”

Simparica Trio delivers on Zoetis’ commitment to innovation in parasiticides

The introduction of Simparica Trio is just the latest example of Zoetis’ commitment to next generation parasiticide products and solutions for veterinarians, enabling them to provide the best prevention and treatment options for pets. In addition to receiving this approval, Zoetis has received approval for two parasiticide innovations in the U.S. in the past 18 months to help protect dogs and cats from harmful pests. ProHeart^® 12 (moxidectin), which was approved in July 2019, is the only once-yearly injection to prevent heartworm disease in dogs 12 months of age and older. In November 2018, Zoetis received approval for Revolution^® Plus (selamectin and sarolaner topical solution), a combination topical product providing 6-in-1 parasite protection against fleas, ticks***, ear mites, roundworms, hookworms**** and heartworm disease for cats and kittens as young as eight weeks of age and weighing 2.8 pounds or greater.

Zoetis expects Simparica Trio to be available to veterinary customers by mid-to-late April. Simparica Trio chewable tablets will be available in six tablet strengths for dogs and puppies eight weeks of age and older weighing at least 2.8 lbs.

For more information, visit www.SimparicaTrioDVM.com.

IMPORTANT SAFETY INFORMATION FOR SIMPARICA TRIO:

Use with caution in dogs with a history of seizures. Simparica Trio contains sarolaner, a member of the isoxazoline class, which has been associated with neurologic adverse reactions including tremors, ataxia, and seizures in dogs with or without a history of neurologic disorders. The safe use of Simparica Trio has not been evaluated in breeding, pregnant, or lactating dogs. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. See full Prescribing Information.

IMPORTANT SAFETY INFORMATION FOR SIMPARICA:

Simparica is for use only in dogs 6 months of age and older. Simparica may cause neurologic signs such as tremors, unsteadiness and/or seizures in dogs with or without a history of neurologic disorders. Simparica has not been evaluated in pregnant, breeding or lactating dogs. The most common adverse reactions in clinical trials were vomiting and diarrhea. See full Prescribing Information.

IMPORTANT SAFETY INFORMATION FOR PROHEART 12:

Use PROHEART 12 in dogs 12 months of age or older. Do not administer to dogs that are sick, debilitated, underweight, have a history of weight loss, or to those previously found to be hypersensitive to the drug. Hypersensitivity reactions may occur in some dogs when PROHEART 12 is administered alone or with vaccines. Anaphylactic and anaphylactoid reactions can result in death and should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products. The most common reported side effects in clinical trials were vomiting, lethargy, diarrhea, and anorexia. People should avoid inhalation, contact with eyes, or accidental self-injection. Certification is required before veterinarians and staff administer PROHEART 12. See full Prescribing Information.

IMPORTANT SAFETY INFORMATION FOR REVOLUTION PLUS:

The safe use of Revolution Plus has not been established in kittens less than 8 weeks old or in breeding, pregnant or lactating cats. Reported side effects in clinical trials included lethargy and anorexia. Use with caution in cats with a history of neurologic disorders. Sarolaner, one of the ingredients in Revolution Plus, is a member of the isoxazoline class, which has been associated with adverse reactions such as tremors, ataxia, and seizures. Reactions have occurred in cats with or without a history of neurologic disorders. In humans, Revolution Plus may be irritating to skin and eyes. See full Prescribing Information.

About Zoetis

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2019, the company generated annual revenue of $6.3 billion with approximately 10,600 employees. For more information, visit www.zoetis.com.

DISCLOSURE NOTICES

Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects, expectations regarding products, including timing of shipments and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

*Lone Star tick (Amblyomma americanum), Gulf Coast tick (Amblyomma maculatum), American dog tick (Dermacentor variabilis), black-legged or deer tick (Ixodes scapularis), and brown dog tick (Rhipicephalus sanguineus)

**Roundworms (Toxocara canis and Toxacaris leonina) & hookworms (Ancylostoma caninum and Uncinaria stenocephala)

^‡ Simparica Trio demonstrated ≥99.4% effectiveness 72 hours after treatment of existing Amblyomma americanum infestations

⁺Nemex-2 Package Insert

⁺⁺Toxascaris leonina data derived from Nemex-2 clinical studies

***Black-legged or deer tick, Gulf Coast tick, and American dog tick

****Roundworm (Toxocara cati) & hookworm (Ancylostoma tubaeforme)

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