Aratana Therapeutics Provides 2013 Development Update
Achieves All Year-End Clinical Milestones
KANSAS CITY, Kan. and BOSTON, Dec. 23, 2013 /PRNewswire/ -- Aratana Therapeutics, Inc., (Nasdaq: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, today provided a year-end update on its development programs. The company continues to advance each of its small molecule drug candidates within the timelines previously guided and has achieved all planned year-end 2013 clinical milestones. Aratana remains on track to reach significant inflection points for these programs in 2014 and beyond.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, commented, "We have had an exciting year marked by successful corporate and clinical execution. As we continue to expand and enhance our pipeline of high-value pet therapeutics, we also remain sharply focused on advancing our clinical programs toward timely approvals. We are proud to maintain our strong clinical track record by achieving our 2013 milestones, and we look forward to reporting on expected clinical developments for the coming year, which include significant progress in both our dog and cat therapeutic programs."
In November, Aratana announced positive top-line data from its pivotal dose-ranging study of AT-001 for dogs, and selected a once-daily dose for further study. Today, the company provided greater detail on the results of that study:
- Clinical success rates at day 28 were 61.6% for the selected once-daily dose of AT-001 vs. 42.2% for the placebo group, when compared in a two-group parallel design, which represents a statistically significant difference (p<0.05)
- Adverse reactions at the selected dose were comparable to the placebo
- Aratana plans to move AT-001 forward into the pivotal field effectiveness study in 2014, and then, if the results are favorable, into commercialization upon approval, which is anticipated to be in 2016
Aratana also announced today that it has initiated the pivotal field effectiveness study for AT-002 in dogs, the company's novel drug candidate for treating inappetence.
- The randomized, placebo-controlled, multi-center study is expected to enroll approximately 150 client–owned dogs beginning in January 2014
- Top-line results are anticipated in the first half of 2015, and the company continues to anticipate potential U.S. approval to be in 2016
In previous studies, laboratory cats and dogs treated with AT-002 exhibited increased food intake and weight gain, and statistically significant results were seen in a dog pilot study of AT-002.
Following an initial meeting with the FDA's Center for Veterinary Medicine (CVM) to present Aratana's AT-003 development program, the company announced its plans to initiate a pilot field study in client-owned dogs in 2014. The study will evaluate AT-003 for post-operative pain management following orthopedic surgery.
Dr. St. Peter concluded, "We anticipate providing further updates on our entire pipeline of pet therapeutics, including our portfolio of pet biologics, on our fourth quarter and full year 2013 financial results conference call."
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 the expansion of our commercial infrastructure; expectations regarding development programs, trials, studies, and approval; expectations regarding in-license initiatives; 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; 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.