Aratana Therapeutics Announces Positive Top-Line Results From AT-001 Dose-Ranging Field Study In Client-Owned Dogs With Osteoarthritis
11/21/2013 11:06:05 AM
KANSAS CITY, Kan. and BOSTON, Nov. 20, 2013 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, today announced positive results from its dose-ranging study of AT-001, the company's innovative drug for treating pain in dogs with osteoarthritis. In the study, dogs receiving AT-001 demonstrated improvements in pain assessment scores that were statistically significant compared to placebo (p<0.05) at a once-daily dose. Aratana expects to move AT-001 forward into the pivotal field effectiveness study in 2014, and then, if the results of the pivotal effectiveness study are favorable, into commercialization upon approval, which is anticipated to be in 2016.
The blinded, placebo-controlled, multi-center dose-ranging study of AT-001 enrolled in excess of 300 client-owned dogs with osteoarthritis. Dogs were randomized equally into three groups treated with AT-001 (two once per day dose groups and one twice per day dose group) and one group treated with placebo. Dogs were dosed for 28 days, and effectiveness was determined by a standard protocol utilizing a validated owner-assessed pain score. Aratana has selected a once-daily dose for further development.
Ernst Heinen, DVM, Ph.D., Head of Drug Evaluation and Development for Aratana Therapeutics, stated, "We are very pleased with these results, which allow us to move forward confidently with a dose of AT-001 that appears safe at therapeutic levels for dogs with osteoarthritis pain."
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, added, "We believe AT-001 has the potential to be an important product in the well-established $260 million pain market in the U.S. alone. We look forward to continuing our dialogue with the Center for Veterinary Medicine regarding the AT-001 program."
Aratana will discuss these results in more detail when the final study reports are available.
About Aratana Therapeutics
Aratana Therapeutics is a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, or pet therapeutics. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. Aratana's strategy is to in-license proprietary compounds from human biopharmaceutical companies and to develop these product candidates into therapeutics specifically for use in pets. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the 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 statements regarding development programs, trials, studies, and approval; the timing of the pivotal field effectiveness study for AT-001; the timing for approval and commercialization of AT-001; the safety of AT-001; the potential for AT-001 to be an important product in the pain market; and the Company's plans and opportunities.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; our substantial dependence on the success of our current compounds, AT-001, AT-002 and AT-003, which are still in development; our inability to identify, license, develop and commercialize additional product candidates; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; uncertainties regarding the outcomes of studies regarding our products; effects of competition; our failure to attract and keep senior management and key scientific personnel; our complete reliance on third-party manufacturers and third parties to conduct all our target animal studies and certain other development efforts; our lack of a sales organization; our significant costs of operating as a public company; our lack of effective internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; our failure to comply with regulatory requirements; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an "emerging growth company," as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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SOURCE Aratana Therapeutics, Inc.
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