KANSAS CITY, Kan., May 12, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for cats, dogs and other companion animals, today announced the initiation of the pivotal field effectiveness study for AT-001 (grapiprant), the company's innovative drug for treating pain in dogs with osteoarthritis.
The randomized, blinded, multicenter pivotal study will enroll approximately 300 client-owned dogs with osteoarthritis, and will be conducted under a study protocol for which Aratana received concurrence from the FDA's Center for Veterinary Medicine (CVM). Dogs participating in the study will be given a once-daily low dose of AT-001 that was determined to be safe at therapeutic levels during the previous dose-ranging study, or placebo. The primary endpoint will be a reduction in osteoarthritis pain compared to placebo, as indicated by the Canine Brief Pain Inventory (CBPI) scale, a well validated and widely used scoring system.
Ernst Heinen, D.V.M, Ph.D., Chief Development Officer of Aratana Therapeutics, stated, "Osteoarthritis is the most common inflammatory joint disease in pets. AT-001 represents a truly differentiated approach to treating pain in pets. We look forward to reporting the pivotal study data, and if the results are favorable, to beginning commercialization upon approval, which is anticipated to be in 2016."
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for cats, dogs and other companion animals. 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 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.
Aratana Therapeutics 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 Aratana's expectations regarding the approval of products; expectations regarding development programs, trials, studies, approvals and commercialization; and expectations regarding Aratana'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 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: Aratana's limited operating history and expectations of losses for the foreseeable future; Aratana's lack of commercial sales; Aratana's failure to obtain any necessary additional financing; Aratana's substantial dependence on the success of certain of Aratana's lead product candidates, AT-001, AT-002, AT-003, AT-004, AT-005, AT-006, AT-007 and AT-008; Aratana's inability to identify, license, develop and commercialize additional product candidates; Aratana's inability to obtain regulatory approval for Aratana's existing or future product candidates; the lack of commercial success of Aratana's current or future product candidates; uncertainties regarding the outcomes of studies regarding Aratana's products; Aratana's inability to realize all of the anticipated benefits of Aratana's acquisitions of Vet Therapeutics and Okapi Sciences; effects of competition; Aratana's failure to attract and keep senior management and key scientific personnel; Aratana's complete reliance on third-party manufacturers and third parties to conduct all Aratana's target animal studies and certain other development efforts; Aratana's lack of a sales organization; Aratana's significant costs of operating as a public company; Aratana's lack of effective internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of Aratana's customers; impacts of generic products; unanticipated safety or efficacy concerns; Aratana's limited patents and patent rights; Aratana's failure to comply with Aratana's intellectual property license obligations; Aratana's infringement of third party patents and challenges to Aratana's patents or rights; Aratana's failure to comply with regulatory requirements; Aratana's failure to report adverse medical events related to Aratana's products; legislative or regulatory changes; the volatility of Aratana's stock price; Aratana's status as an "emerging growth company," as defined in the JOBS Act; the potential for dilution if we sell shares of Aratana's common stock in future financings; the significant control over Aratana's business by Aratana's principal stockholders and management; the potential that a significant portion of Aratana's total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in Aratana's charter documents and under Delaware law; and Aratana's intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 26, 2014, along with Aratana's 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 Aratana's views to change. These forward-looking statements should not be relied upon as representing Aratana's views as of any date subsequent to the date of this press release.
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