San Francisco, CA (May 7, 2018) 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 approved Mirataz (mirtazapine transdermal ointment) for the management of weight loss in cats.
“We are pleased to announce the FDA approval of Mirataz for cats experiencing unintended weight loss, a serious medical and potentially fatal condition,” said Richard Chin, M.D., President and Chief Executive Officer of KindredBio. “Based on our market research, we estimate that veterinarians in the U.S. see as many as 9 million cats each year with unintended weight loss due to various underlying conditions. We developed this first-in-class product in less than five years, which is a testament to the quality of our team and validates our strategy of quickly and cost-efficiently developing animal health therapeutics.”
Mirataz is the first and only transdermal medication specifically developed, and FDA approved, for cats. Weight loss is the leading cause of visits to the veterinarian for cats. Mirataz, which is formulated with KindredBio’s proprietary Accusorb™ technology, is applied topically to the cat’s inner ear (pinna) once a day, providing a more attractive application route compared to oral administration. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated body weight gain in cats experiencing weight loss. The product is classified as a weight gain drug and can be used in cats with various underlying diseases associated with unintended weight loss.
KindredBio will provide additional updates regarding commercialization and pipeline during its first quarter 2018 financial call on Tuesday, May 8, 2018 at 4:30 PM Eastern Time / 1:30 PM Pacific Time. Interested parties may access the call by dialing toll-free (855) 433-0927 from the US, or (484) 756-4262 internationally, and using conference ID 8967967. The call will also be webcast live at https://edge.media-server.com/m6/p/nhw6xeop.
About Kindred Biosciences
Kindred Biosciences is a 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 effectiveness in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes. KindredBio’s first approved drug is Mirataz™ (mirtazapine transdermal ointment) for the management of weight loss in cats.
Important Safety Information
MiratazTM (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.
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