Kindred Biosciences (KIN) Submits Mirataz's New Animal Drug Application Technical Section to FDA

August 22, 2016 4:09 PM EDT

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Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission of the Effectiveness Technical Section of the New Animal Drug Application for Mirataz™ (mirtazapine transdermal ointment) to the Food and Drug Administration (FDA) for the management of weight loss in cats. The Chemistry, Manufacturing, and Controls Technical Section was submitted in May 2016 and the Company plans to submit the Safety Technical Section in the third quarter of 2016.

The multicenter, randomized, double-blind, placebo-controlled pivotal field study enrolled 231 cats to assess the effectiveness of Mirataz for the management of weight loss in cats. The primary endpoint was percentage change in body weight from Day 1 to Week 2. At Week 2, the mean percent increase in body weight from Day 1 was 4.07% in the KIND-010 group (n=90), versus 0.29% in the placebo group (n=97) (p<0.0001). Based on a review of the safety data, the drug appears to be well tolerated.

"We are excited about the market potential for Mirataz and are pleased to bring this program one step closer to approval. Managing weight loss in cats is a serious unmet medical need, with an estimated 9 million cats in the U.S. suffering from inappetence. As a transdermal product, Mirataz is an attractive alternative for veterinarians and owners to administering a drug orally to cats. I want to thank the KindredBio team and our investigators for their hard work as we advance our plan to launch Mirataz," stated Richard Chin, M.D., President and CEO of KindredBio.

Weight loss is one of the leading causes of veterinary visits among cat owners, and a veterinarian will see on average 7 cats per week with this condition. In many cases, significant weight loss can lead to liver failure and ultimately death. Currently, there are limited options for the management of weight loss in cats, none of which include an FDA-approved transdermal option. As a transdermal product, Mirataz is formulated using KindredBio's Accusorb™ technology, which results in high and predictable absorption. About 80% of veterinarians surveyed have indicated their intent to use the product, based on the Company's market research.



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