- 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. , 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.
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"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 day(1). Mirataz, which is formulated with KindredBio's proprietary Accusorb(TM) 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® [https://c212.net/c/link/?t=0&l=en&o=2669308-1&h=177166077&u=https%3A%2F%2Fkindredbio.com%2Fmirataz%2F&a=Mirataz%C2%AE] (mirtazapine transdermal ointment) and Zimeta(TM) [https://c212.net/c/link/?t=0&l=en&o=2669308-1&h=720031688&u=https%3A%2F%2Fkindredbio.com%2Fzimeta%2F&a=Zimeta%E2%84%A2] (dipyrone injection).
Aniserve offers business support services to the animal health and nutrition industry, start-ups, small and medium enterprises and established players. We support our clients to register their company and products in Europe and abroad. Our services include acting as representatives towards regulatory authorities including acting as applicant for submissions of dossiers to register veterinary medicinal products and feed additives and marketing authorization holder. We support our clients in establishing subsidiaries in Europe complying with veterinary pharmaceutical legislation to establish their business activities. With our network of partners, we can support our clients in most regions of the world.
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.
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(1) Summary of Product Characteristics
for Mirataz(R) 20 mg/g transdermal
ointment for cats, Aniserve GmbH
(Munich, Germany) on behalf of Kindred
Biosciences, Inc. (Burlingame, CA). EU/
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Web site: http://www.kindredbio.com/