Kindred Biosciences Announces European Commission Approval of Mirataz 20 mg/g Transdermal Ointment for Cats Experiencing Poor Appetite and Weight Loss

- Mirataz is the first and only medication approved in the European Union to treat cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

SAN FRANCISCO, Dec. 12, 2019 /PRNewswire/ -- Kindred Biosciences, Inc. (Nasdaq: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, today announced that the European Commission has granted marketing authorization of Mirataz for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

"We are excited to gain approval in the European Union for Mirataz, our second product approval in 2019," said Kindred Biosciences Chief Executive Officer, Richard Chin, M.D. "We are pleased to continue to build on our track record of successes, as we bring this innovative product to new geographies."

Mirataz is the first and only medication approved in the EU to induce bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Europe represents the second largest market for veterinary therapeutics internationally. Regulations restrict use of human medicine once an approved therapeutic is available. The authorization is valid in all 28-member states of the European Union, together with Iceland, Liechtenstein, and Norway.

The approval of Mirataz in the European Union is based on results from both clinical and non-clinical studies. Mirataz is a serotonin (5HT2A, 5HT2C, and 5HT3) and histamine (H1) receptor antagonist, which has demonstrated body weight gain in cats experiencing poor appetite and weight loss from chronic medical conditions. In clinical studies, Mirataz resulted in significant weight gain in cats in as little as 14 days following topical application of 2 mg per day¹. 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 different application route compared to oral administration.

Aniserve GmbH is the marketing authorization holder acting on behalf of Kindred Biosciences in Europe.

Mirataz (mirtazapine transdermal ointment) was approved for use in cats by the U.S. Food & Drug Administration in May 2018.

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) and Zimeta (dipyrone injection).