Aratana Therapeutics Receives Technical Section Complete Letter for Effectiveness for AT-002
LEAWOOD, Kan., Feb. 23, 2016 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, announced today that the Company received a technical section complete letter for effectiveness from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) for AT-002, an investigational therapeutic that has not yet received CVM approval and is also known as ENTYCE® (capromorelin oral solution), for appetite stimulation in dogs. Entyce, a ghrelin agonist, works to treat inappetence by mimicking ghrelin, the hunger hormone, to stimulate appetite.
The technical section complete letter for effectiveness is the last of three major technical section complete letters required to file an administrative New Animal Drug Application (NADA) for approval and follows the technical section complete letter for safety received in March 2015, along with the technical section complete letter for chemistry, manufacturing and controls (CMC) received by the Company in September 2015. Aratana plans to finalize the product label, complete the other minor sections and submit an administrative NADA. If Entyce receives FDA approval, Aratana is expected to commence commercialization in late-2016 or shortly thereafter.
The technical section complete letter for effectiveness was based on results from a double-masked, randomized, placebo-controlled pivotal study of 244 dogs evaluating the efficacy of Entyce in dogs with various medical conditions that demonstrated reduced or no appetite for a minimum of two days. The primary endpoint of the study was an owner assessment of appetite using an "increased," "no change" or "decreased" scoring system. The statically significant results (p=0.0078) of the owner assessment showed 68.6 percent of dogs had an increased appetite compared to 44.6 percent of the dogs receiving placebo. The secondary endpoints of the study showed Entyce successfully increased the owner appetite assessment questionnaire score (56.2 percent compared to 26.8 percent in placebo; p=0.0071) and increased body weight in dogs enrolled in the study (76.0 percent compared to 44.6 percent in placebo; p=0.0012). The therapeutic was well-tolerated and adverse reactions in the study were infrequent and mild.
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 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 our ability to bring several innovative products to market beginning in 2016 and/or 2017; expectations regarding the timing of discussions with regulatory authorities and the approval of AT-002 (Entyce) in the U.S.; expectations regarding the timing or scope of commercialization of products; and the Company's plans and opportunities, including without limitation offering innovative therapeutics.
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 history of operating losses and expectations of losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; our substantial dependence on the success of certain of our product candidates; our dependence on novel technologies and compliance with complex regulatory requirements; 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; our inability to realize all of the anticipated benefits of our acquisitions and difficulty integrating acquired businesses; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our inability to identify, license, develop and commercialize additional product candidates; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, and partners; regulatory restrictions on the marketing of our product candidates; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing; our small commercial organization; difficulties managing the growth of our organization; our significant costs of operating as a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013 and the identification of a material weakness in our internal control over financial reporting; risks relating to the impairment of intangible assets AT-004, AT-005, AT-007 and AT-011; changes in distribution channels for pet therapeutics; consolidation of our customers; limitations on our ability to use our net operating carryforwards; impact 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; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process; our failure to comply with regulatory requirements or obtain foreign regulatory approvals; 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 influence of significant stockholders over our business; and effects of anti-takeover provisions in our charter documents and under Delaware law. 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 16, 2015, 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.
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