SAN FRANCISCO, Oct. 10, 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 Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a positive opinion recommending marketing authorization of Mirataz® (mirtazapine transdermal ointment) for bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Furthermore, KindredBio announced that it recently filed for regulatory approval of Mirataz in Canada.
"Today's positive CVMP opinion marks a key achievement for KindredBio. Europe is the second largest market for veterinary therapeutics globally. As the first medication expected to be approved for poor appetite and weight loss in cats in the EU, we are once again at the forefront of addressing unmet needs in veterinary medicine. This anticipated approval provides further validation of our rapid and cost-efficient development model," said Richard Chin, Chief Executive Officer of KindredBio. "We expect European uptake of Mirataz to benefit from regulations prohibiting use of human medicine once an approved veterinary therapeutic is available."
If approved in the European Union, Mirataz would be the first and only medication approved to induce bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions. Weight loss is a leading cause of visits to the veterinarian for cats in Europe.
A marketing authorization decision from the European Commission is anticipated within approximately two months. Regulatory approval is subject to the typical risks inherent in such a process. If approved, the authorization will be valid in all 28-member states of the European Union, as well as Iceland, Liechtenstein, and Norway. In Canada, the validation of the Canadian submission will be complete in the next 30 to 45 days and once accepted for review, the review timeline is approximately one year.
The CVMP's positive opinion 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.
Mirataz was approved by the U.S. Food & Drug Administration in May 2018 for the management of weight loss in cats.
Important Safety Information
Mirataz® (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.
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. Its first approved drug is Mirataz® (mirtazapine transdermal ointment) for the management of weight loss in cats.
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.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and our lead product candidates which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our products and our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain and maintain patent protection and other intellectual property protection for our products and our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.
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.
1 Mirataz® (mirtazapine transdermal ointment) [package insert], Kindred Biosciences, Inc. (Burlingame, CA). Rev. 5/2018.
SOURCE Kindred Biosciences, Inc.