San Francisco, California (November 25, 2019) – Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the U.S. Food and Drug Administration’s Center for Veterinary Medicine has approved Zimeta™ (dipyrone injection) for the control of pyrexia in horses.
Pyrexia, or fever, is associated with a number of underlying diseases and can result in significant negative outcomes, including dehydration, laminitis, muscle wasting, weight loss, and in some cases death. Among performance horses, fever can also lead to loss of training and competition days. There are more than eight million horses in the United States, and over one million are seen by a veterinarian for fever annually.
Zimeta is the first and only FDA-approved medication for the control of pyrexia (fever) in horses.
“The equine community has been eagerly anticipating an FDA-approved safe and effective product to control fever in horses,” said Denise Bevers, President and COO of KindredBio. “Equine pyrexia is an attractive market for KindredBio, with high unmet medical need and a commitment to treat. This second KindredBio commercial product was developed in five years and at a cost of $5 million, consistent with our business model. It positions KindredBio as a key player in the equine community as we advance a pipeline of promising drug candidates for horses.”
Zimeta, which is classified as a nonsteroidal anti-inflammatory drug, targets fever centrally in the brain, where it originates. In a clinical study, Zimeta demonstrated rapid and effective fever reduction in horses with naturally occurring fever. The most common cause of fever in horses is respiratory disease, both viral and bacterial, but fever also can occur with other infections or inflammation of any body system. Zimeta is administered intravenously at 30 mg/kg once or twice daily, at 12-hour intervals, for up to three days. The overall number of doses and duration of treatment is dependent on the response observed (fever reduction). Zimeta may be re-administered based on recurrence of fever for up to three days.
KindredBio is proud to be a member of the American Association of Equine Practitioners (AAEP) Educational and Media Partners Program. The program represents industry-leading corporations, media outlets, and industry organizations dedicated to providing resources and education through AAEP to equine veterinarians and horse owners to improve the health and welfare of the horse. Nearly 9,300 veterinarians and veterinary students across more than 60 countries are members of the AAEP.
Important Safety Information
ZimetaTM (dipyrone injection) should not be used more frequently than every 12 hours. For use in horses only. Do not use in horses with a hypersensitivity to dipyrone, horses intended for human consumption or any food producing animals, including lactating dairy animals. Not for use in humans, avoid contact with skin and keep out of reach of children. Take care to avoid accidental self-injection and use routine precautions when handling and using loaded syringes. Prior to use, horses should undergo a thorough history and physical examination by a veterinarian. Monitor for signs of abnormal bleeding and use caution in horses at risk for hemorrhage. Concurrent use with other NSAIDs, corticosteroids and drugs associated with kidney toxicity, should be avoided. As a class, NSAIDs may be associated with gastrointestinal, kidney, and liver toxicity. The most common adverse reactions observed during clinical trials were elevated glucose conversion enzymes, decreased blood protein, and gastric ulcers. Please see the full Prescribing Information.
Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves to apply and wash hands after. Avoid contact with treated cat for 2 hours following application. The most common adverse reactions include application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. Please see the full Prescribing Information.
About Kindred Biosciences
Kindred Biosciences is a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. KindredBio has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. The company has two approved drugs, namely Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats and Zimeta™ (dipyrone injection) for the control of fever in horses.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
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