Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataztm New Animal Drug Application

SAN FRANCISCO, Feb. 6, 2017 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has received a technical section complete letter for effectiveness from the U.S. Food and Drug Administration's Center for Veterinary Medicine for Mirataztm (mirtazapine transdermal ointment) approving the technical section. 

The basis for this complete letter was a multicenter, randomized, double-blind, placebo-controlled pivotal field study that enrolled 230 cats to assess the effectiveness of Mirataz in managing weight loss in cats. The primary endpoint was mean 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 3.94% in the Mirataz group (n=83), versus 0.41% in the placebo group (n=94) (p<0.0001). Based on a preliminary review of the safety data, the drug appears to be well tolerated.

Richard Chin, CEO of KindredBio, stated, "This is a major milestone for KindredBio, and it is a testament to the quality of the submission and the significant unmet medical need that it was reviewed by the FDA in a single cycle and ahead of the standard (ADUFA) timelines. We look forward to the launch of the first FDA-approved drug for the management of weight loss in cats, the most common reason for feline veterinary visits in United States. We expect the approval of Mirataz in the second half of 2017 assuming no unforeseen delays in the review process."

About Kindred Biosciences, Inc. 

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.

For more information or to download the corporate presentation, visit www.KindredBio.com/LearnMore. Stay connected with KindredBio on Facebook at www.Facebook.com/KindredBio.

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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. 

Contact

Russell Radefeld
KindredBio
[email protected] 
(650) 701-7904

SOURCE Kindred Biosciences, Inc.