Aratana Therapeutics Files for Second FDA Approval
First-in-Class Ghrelin Agonist
LEAWOOD, Kan., March 22, 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, today announced the Company submitted an administrative New Animal Drug Application (NADA) for ENTYCE® (capromorelin oral solution) with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) for appetite stimulation for dogs. The Animal Drug User Fee Act (ADUFA) date is May 21, 2016. Aratana anticipates Entyce will be commercially available to veterinarians in late-2016 or shortly thereafter.
Entyce, a ghrelin agonist, is a new chemical entity and a first-of-its-kind therapeutic to treat inappetence in dogs. The therapeutic is a flavored, oral liquid prescription that works by mimicking ghrelin, the hunger hormone, to stimulate appetite.
"Our market research indicates that millions of dogs with inappetence are treated off-label with drugs, special diets and homeopathic remedies," stated Ernst Heinen, DVM, PhD, Chief Development Officer of Aratana Therapeutics. "The anticipated FDA approval of Entyce would make it the only therapeutic approved for use by veterinarians to fulfill a serious unmet need for dogs that have stopped eating."
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative pharmaceutical products for dogs and cats. Aratana believes that it can leverage the investment in the human pharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The Company has multiple products approved by the Food and Drug Administration's Center for Veterinary Medicine or licensed by the United States Department of Agriculture. The Company's pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious, unmet or underserved medical needs. Aratana believes providing innovative options to veterinarians and pet owners will help manage pets' medical needs safely and effectively, result 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; expectations regarding the timing of discussions with regulatory authorities and approval of AT-002 (Entyce) in the U.S.; expectations regarding the timing or scope of commercialization of Entyce; and the Company's plans and opportunities, including without limitation offering innovative therapeutics that fulfill serious unmet needs.
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; risks relating to the impairment of intangible assets AT-004, AT-005, AT-007 and AT-011; effects of unstable market and economic conditions; restrictions placed on our operating and financial flexibility by the terms of our credit facility; 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; 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 15, 2016, 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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