Aratana Therapeutics Files for USDA Product License of AT-014 Canine Osteosarcoma Immunotherapy
KANSAS CITY, Kan., July 2, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals, today announced that it has filed for a product license from the United States Department of Agriculture (USDA) for AT-014, a novel her2/neu-directed cancer immunotherapy licensed exclusively from Advaxis, Inc. (NASDAQ: ADXS) for the treatment of canine osteosarcoma and other cancers. While the USDA has no specific obligation to respond within a prescribed timeframe, Aratana anticipates that responses from the USDA to the filing will occur over the next 12 to 18 months.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "Aratana has established a robust, late-stage pipeline of novel therapeutic candidates for treating canine cancers through the strategic acquisition and licensing of high quality immune-oncology assets. Each of our canine-specific monoclonal antibodies for treating T- and B-cell lymphoma has received a conditional license from the USDA, and we are pleased to continue this track record of innovation with the advancement of AT-014 toward this important regulatory milestone. Our goal is to develop products which allow veterinarians to better manage the care of their canine patients suffering from these common cancers."
AT-014 was developed by Advaxis for the treatment of her2-overexpressing cancers. Preliminary findings from an ongoing clinical study of AT-014 in client-owned dogs with osteosarcoma were presented in June at the American College of Veterinary Internal Medicine (ACVIM) Forum by clinical investigator Nicola Mason, BVetMed, PhD, DACVIM, of the University of Pennsylvania School of Veterinary Medicine. The preliminary data suggest that AT-014 is safe and well tolerated, and may be able to delay or prevent metastatic disease and prolong overall survival in dogs with osteosarcoma that had minimal residual disease following standard of care amputation and chemotherapy. Currently, immunological analysis is underway for this study, and Dr. Mason is conducting a second study evaluating combination therapy with AT-014 immunotherapy and radiation for dogs with primary osteosarcoma that cannot undergo amputation.
About Canine Osteosarcoma
Osteosarcoma is the most common primary bone tumor in dogs, accounting for roughly 85% of tumors on the canine skeleton. Approximately 8,000-20,000 dogs a year (predominantly middle to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States. This cancer initially presents as lameness and, oftentimes, visible swelling on the leg. Current standard of care treatment is amputation immediately after diagnosis, followed by chemotherapy and sometimes radiation. Invariably, the cancer metastasizes to the lungs, eventually leading to death.
About Aratana Therapeutics, Inc.
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing 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. 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 statements regarding our expectations regarding the approval of products; expectations regarding development programs, trials, studies, approvals and commercialization; expectations regarding in-license initiatives and partnerships; 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 certain of our lead product candidates, AT-001, AT-002, AT-003, AT-004, AT-005, AT-006 , AT-007, AT-008 and AT-014; 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; 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 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.
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