FLORHAM PARK, N.J.--(BUSINESS WIRE)--Zoetis Inc. today announced that the European Commission has granted marketing authorization for SimparicaTM (sarolaner) chewable tablets, a once-monthly medication for the treatment of fleas, ticks and sarcoptic mange in dogs beginning at eight weeks of age. The approval follows a positive opinion adopted by the Committee for Medicinal Products for Veterinary Use in September 2015.
“The approval of Simparica gives veterinarians a new oral choice in parasite control for dogs,” said Dr. Balázs Capári, veterinary specialist, small animal medicine, in Sümeg, Hungary, who participated in clinical trials of Simparica.1 “In my experience, Simparica has been shown to rapidly kill fleas and ticks with efficacy that persists for five weeks. Dog owners participating in the trials also reported that Simparica is very palatable; the chewable tablet was easily taken by their dogs. The convenience of a once monthly chewable tablet helps increase compliance with treatment, giving veterinarians and dog owners confidence in continuous protection.”
“At Zoetis, we focus our innovation on the most pressing needs of veterinarians, and that is what guided us to develop a new oral choice to provide dogs with persistent protection from fleas and ticks and treatment of mites that cause sarcoptic mange,” said Dr. Catherine Knupp, executive vice president and president, Research and Development at Zoetis. “Simparica is a result of the collaboration of Zoetis scientists worldwide, who share a determination to develop new medicines that deliver real value to our veterinary customers and the animals in their care. We are excited to bring this innovative medicine, Simparica, to veterinarians and dog owners across Europe.”
The global market for antiparasitics in pets was over $4.2 billion dollars in 2014, with a compound annual growth rate of 5% over the previous five years, driven largely by growth of new oral products, according to Vetnosis.2
Simparica Results from Zoetis Innovation with New Ectoparasiticide -- Sarolaner
The active substance of Simparica is sarolaner, a new ectoparasiticide in the isoxazoline class, developed by Zoetis scientists. The marketing authorization for Simparica was based on the results of field studies conducted in seven countries, involving more than 800 dogs of various breeds from at least eight weeks of age and 1.3 kg of weight. Simparica was shown to provide efficacy for at least five weeks against ticks and fleas. It demonstrated a rapid onset of action, killing fleas before they have a chance to lay eggs and can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis. It proved effective in treating sarcoptic mange, a highly contagious skin disease in dogs.
In studies, Simparica killed all four species of tick dominant in Europe (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus) and species of flea that most frequently infect dogs in European countries (Ctenocephalides felis and Ctenocephalides canis). Simparica was well tolerated with no adverse events reported at the therapeutic dose.
Zoetis expects to launch Simparica in the EU in the first quarter of 2016. Simparica chewable tablets will be available in 5 mg, 10 mg, 20 mg, 40 mg and 80 mg dosage strengths.
For more information about Simparica and full prescribing information, visit http://www.zoetis.com/products-services/companion-animals/dogs.
About Zoetis
Zoetis (zô-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2014, the company generated annual revenue of $4.8 billion. With approximately 10,000 employees worldwide at the beginning of 2015, Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in 120 countries. 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, future operating or financial performance, expectations regarding products, future use of cash and dividend payments, 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, 2014, including in the sections thereof captioned “Forward-Looking Information 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.
1 Dr. Balázs Capári, is a clinical investigator of Simparica and consultant to Zoetis Inc.
2 Vetnosis, Animal Health Service: Parasiticides Report (Sept. 2015)
