Kindred Biosciences Receives FDA Approval of Zimeta(TM) (dipyrone injection) for the Control of Pyrexia in Horses

SAN FRANCISCO, Nov. 25, 2019 /PRNewswire/ -- 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

Zimeta^TM (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.

Forward-Looking Statements 

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. 

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and our lead product candidates which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our products and our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain and maintain patent protection and other intellectual property protection for our products and our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management. 

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.

Contacts

For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com 
(917) 969-3438

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SOURCE Kindred Biosciences, Inc.