KANSAS CITY, Kan., Sept. 9, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals, today announced positive results from its pilot field study of its Bupivacaine Extended-Release Injectable Suspension (AT-003) for managing post-operative pain in cats and dogs following surgery. In the study, which enrolled 46 client-owned dogs, AT-003 demonstrated significantly greater pain control over time following knee surgery compared to placebo. Based on these results, Aratana anticipates discussing the design of the pivotal field effectiveness with the FDA in the coming weeks and continues to anticipate the first FDA approval in 2016.
Pain levels were assessed repeatedly for 72 hours following knee surgery using the Glasgow Composite Measure Pain Scale, short form (CMPS-SF), a well-accepted and reliable metric for measuring acute pain in dogs. The data show that treatment with AT-003 resulted in a statistically significant reduction in mean total pain scores over time compared to placebo (p<0.05).
Aratana also analyzed the data for "no pain intervention post-surgery". The percent of patients treated with AT-003 which did not require additional pain medication was statistically greater (p<0.05) compared to placebo at each 24-hour time interval (0-24h, 24-48h, 48-72h) for up to 72 hours after surgery.
Steven St. Peter, M.D., President and Chief Executive Officer, stated, "The positive results from this pilot field study of AT-003 are highly encouraging and enable us to move forward with our plans for a pivotal effectiveness study in dogs. As previously announced, our next step will be to discuss the design of the pivotal field trial with the FDA. We believe we remain on track for FDA approval of AT-003 for use in dogs in 2016. In addition, we expect to start a cat pilot lab study in the fourth quarter 2014, potentially expanding the companion animal market for this exciting product, which is already approved and commercially available for use in humans in the United States."
Ernst Heinen, D.V.M., Ph.D., Chief Development Officer, stated, "At Aratana, we generally first conduct pilot lab and field studies then, when indicated, move into pivotal studies. We invest in pilot studies so that we can assess the statistical power and understand the endpoints, which we believe de-risks our drug development. This has been our approach since inception. Our confidence in our six lead programs is greatly enhanced by such pilot studies."
AT-003 was licensed from Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX).
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for 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. The Company's pipeline includes more than fifteen therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions. 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 without limitation statements with respect to expectations regarding the timing of discussions with the FDA and approval of products; expectations regarding development programs, trials, studies and commercialization; and expectations regarding 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; market conditions and our ability to raise capital under the shelf registration statement from the sale of our securities; our substantial dependence on the success of certain of our lead product candidates, 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; our inability to realize all of the anticipated benefits of our acquisitions of Vet Therapeutics and Okapi Sciences; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, partners and other third parties which conduct 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 current exemption from the requirement to maintain internal control over financial reporting, and any failure to achieve or maintain effective internal control over financial reporting in the future; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; limitations on our ability to use our net operating carryforwards; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 26, 2014, along with 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.
Contacts:
For investor inquires:
Aratana Therapeutics, Inc.
Craig Tooman
ctooman@aratana.com; (913) 353-1023
For media inquiries:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694
SOURCE Aratana Therapeutics, Inc.