San Francisco, CA (August 22, 2016) 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 in stimulating weight gain 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, it 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.
About Kindred Biosciences
Kindred Biosciences is a development-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. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.
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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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.