LEPTO EQ INNOVATOR® from Zoetis Licensed for Use in Pregnant Mares

Extended approval shows the only equine leptospirosis vaccine is safe for use
in all trimesters of pregnancy

FLORHAM PARK, N.J., September 22, 2016 — Zoetis today announced LEPTO EQ INNOVATOR®, the only equine leptospirosis vaccine against L. pomona, received additional approval for use in broodmares for all three trimesters of pregnancy. Field safety studies, which examined the vaccine when used in the first, second and third trimesters of pregnancy, showed no systemic or local reactions to vaccination.1,2

“Leptospires can cause late-term abortion in mares,” said Jacquelin Boggs, DVM, MS, ACVIM, senior veterinarian, Equine Technical Services at Zoetis. “The expanded label claim allows the equine breeding community the flexibility to use LEPTO EQ INNOVATOR to fit their breeding program’s needs and help elevate antibody titer levels when most needed.”

A study showed that 13% of bacterial abortions are caused by L. pomona, the most common leptospiral serovar found in horses.3 Aborting mares have been reported to shed leptospires in their urine for periods up to three months and can transmit Leptospira to exposed animals.3 Some horses aborting due to leptospiral infection develop uveitis several weeks to months later.3 Additionally, the aborted fetus is a source of exposure to other horses on the property.

Prior to launching LEPTO EQ INNOVATOR, Zoetis conducted intensive safety and efficacy trials which showed 0% urinary shedding in vaccinated horses challenged with L. pomona.4 Additional studies showed 99.8% of vaccinated horses were reaction-free with no adverse events.2,5

“The additional field safety study in first and third trimester mares was conducted following the launch of LEPTO EQ INNOVATOR to provide veterinarians and horse owners confidence in the vaccine across all phases of pregnancy,” said Dr. Boggs. “Additionally, the study highlights the ongoing dedication from Zoetis to provide the equine industry a product they can have confidence in.”

LEPTO EQ INNOVATOR helps prevent leptospiremia caused by Leptospira interrogans serovar Pomona (L. pomona) which could, but has not been demonstrated to, help reduce the potential risk of equine recurrent uveitis (ERU) infections, abortions or acute renal failure caused by L. pomona.* Previously unvaccinated healthy mares should receive two doses of LEPTO EQ INNOVATOR approximately three to four weeks apart. Annual revaccination with a single dose is recommended.

Zoetis continues to invest in research and development to bring advanced vaccine solutions to the equine industry. LEPTO EQ INNOVATOR enriches the broad portfolio of equine vaccines which also includes FLUVAC INNOVATOR®, WEST NILE-INNOVATOR®, PINNACLE® I.N. and PNEUMABORT-K® + 1b. INNOVATOR vaccines are the veterinarian and horse owner’s first choice for equine influenza and West Nile protection.6 Only INNOVATOR vaccines are adjuvanted with MetaStim®, a proprietary adjuvant system designed for safe, enhanced presentation of antigens to the horse’s immune system, featuring a dual-phase formulation shown to stimulate both cell-mediated and humoral immunity for improved immune responses to West Nile virus.7,8  

To see if your horse is at risk for leptospirosis and to learn more about this potentially deadly disease, visit www.LEPTOEQUINNOVATOR.com.

About Zoetis
Zoetis (zō-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. 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 2015, the company generated annual revenue of $4.8 billion with approximately 9,000 employees. For more information, visit www.zoetisUS.com.

For Further information contact:
Sally Amtmann

Kassi Hoxmeier
Bader Rutter

*Currently, there are no vaccines available with USDA-licensed label claims against equine abortions, uveitis or acute renal failure due to L. pomona.

1 Data on file, Study Report No. B951R-US-15-092, Zoetis LLC.
2 Data on file, Study Report No. B951R-US-13-046, Zoetis LLC.
3 Divers TJ, Chang Y-F. Leptospirosis. In: Robinson NE, Sprayberry KA, eds. Current Therapy in Equine Medicine. Vol 6. 6th ed. St. Louis, Mo: Saunders Elsevier, 2009:145-147.
4 Data on file, Study Report No. B850R-US-12-011, Zoetis LLC.
5 Data on file, Study Report No. B951R-US-13-043, Zoetis LLC.
6 Data on file, MDI sales data for WEST NILE-INNOVATOR and FLUVAC INNOVATOR as of 12/31/15, Zoetis LLC.
7 Davis EG, Zhang Y, Tuttle J, et al. Investigation of antigen specific lymphocyte responses in healthy horses vaccinated with an inactivated West Nile virus vaccine. Vet Immunol Immunopathol. 2008;126(3-4):293-301.
8 Davis EG, Bello NM, Bryan AJ, et al. Characterisation of immune responses in healthy foals when a multivalent vaccine protocol was initiated at age 90 or 180 days. Equine Vet J. 2014. doi:10.1111/evj.12350.



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