KANSAS CITY, Kan., Feb. 10, 2015 /PRNewswire/ -- Aratana Therapeutics, Inc. (PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today provided several product updates. The company continues to advance its deep pipeline of novel therapeutics, including four products at pivotal stage (AT-001, AT-002, AT-003 and AT-014) and two products in post-approval marketing studies (AT-004 and AT-005). Aratana remains on track to achieve additional significant inflection points for its programs in 2015, including results from pivotal field effectiveness studies of AT-002 and AT-003, each in dogs.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, commented, "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 and meeting the critical commercial manufacturing objectives. We are particularly pleased that our model of developing innovative pet therapeutics is being validated by these achievements. We look forward to reporting on further clinical developments as the year progresses."
AT-001
In December 2014, Aratana announced positive top-line data from its pivotal field effectiveness study of AT-001 for osteoarthritis pain in dogs. Today, the company provided additional details:
The blinded, placebo-controlled, multi-center study of AT-001 enrolled approximately 280 client-owned dogs with osteoarthritis. Dogs were randomized equally into one group treated with AT-001 and one group treated with placebo. Dogs were dosed for 28 days, and effectiveness was determined.
Clinical success rates based on the validated Canine Brief Pain Inventory (CBPI) at day 28 were 48.1% for the once-daily dose of AT-001 vs. 31.3% for the placebo group which represents a statistically significant difference (p<0.05), thereby achieving the study's primary endpoint as agreed under protocol concurrence with the FDA's Center for Veterinary Medicine (CVM). The two subsets of the CBPI, the Pain Severity Score and the Pain Interference Score both improved significantly on day 28 (p<0.01). Furthermore, the clinical success rates on days 7, 14 and 21 vs. placebo group were all statistically significant (p<0.05).
Adverse reactions in the pivotal field effectiveness study were limited to mild adverse events and AT-001 was not associated with abnormalities in liver and renal parameters that are associated with NSAIDs from the class of cyclooxygenase inhibitors, or Coxibs.
Aratana anticipates submitting the pivotal study results to the CVM to satisfy the effectiveness technical section in 2015.
In January 2015, Aratana received the target animal safety technical section complete letter for AT-001 in dogs from the CVM.
Aratana anticipates the CMC technical section complete letter for AT-001 in 2016, after which it anticipates filing an Administrative New Animal Drug Application (NADA) in 2016. Aratana continues to anticipate approval of AT-001 in dogs in 2016.
AT-003
The company initiated its pivotal field effectiveness study in dogs for AT-003 in December 2014. The study will evaluate AT-003 for post-operative pain management in dogs undergoing knee surgery.
In January 2015, Aratana received the target animal safety technical section complete letter for AT-003 in dogs from the CVM.
The company continues to anticipate approval of AT-003 in dogs in 2016.
AT-004
The company announced on January 5, 2015 that it received a full license from the U.S. Department of Agriculture (USDA) for its monoclonal antibody to aid in the treatment of canine B-cell lymphoma. AT-004 is exclusively licensed to a third party for commercialization in the U.S. and Canada.
The licensee recently placed a quality hold on AT-004 when it determined that there was a potential quality issue in the manufacturing of one serial lot of AT-004. Aratana initiated and continues an investigation into the serial lot and has placed a stop sale on that lot, which was manufactured in 2013 and whose expiry extension was recently approved by the USDA.
AT-005
AT-005 has received a conditional license from the USDA in January 2014 as an aid in the treatment of canine T-cell lymphoma, and Aratana continues to anticipate receiving a full license in 2015.
Aratana continues to evaluate its canine-specific monoclonal antibody targeting CD52 as an aid in the treatment of T-cell lymphoma in dogs:
Aratana has successfully completed enrollment of its T-CHOMP study -- a multicenter, blinded, placebo-controlled, randomized study designed to assess the benefit of adding AT-005 to a multi-agent chemotherapy protocol for dogs with intermediate to high grade T-cell lymphoma. There are 48 client-owned dogs enrolled in this study. All enrolled dogs are receiving the current chemotherapy standard of care (CHOP protocol) which is supplemented by either placebo or the monoclonal antibody. Dogs are randomized equally (1:1) to receive antibody or placebo during the chemotherapy protocol and the veterinary oncologist performing the dogs' evaluations is blinded to their group assignment. The study is expected to be completed by third quarter 2016.
Aratana continues to enroll patients in its T-LAB study – a multicenter, blinded, placebo-controlled, randomized study designed to assess the benefit of adding AT-005 to an abbreviated chemotherapy protocol for dogs with intermediate to high grade T-cell lymphoma. The study is expected to fully-enroll in 2015 and results are expected in 2016.
Aratana continues to expand AT-005 availability in its T-cell Clinical Experience Program or T-CEP. Aratana is currently receiving product orders from approximately two dozen oncology practices.
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 expectations regarding the timing of discussions with the FDA and/or USDA and approval and licensure of products; expectations regarding development programs, trials, studies and commercialization; expectations regarding in-licensing initiatives and collaborations; 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; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing; 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, and the Company's Quarterly Report on Form 10-Q filed with the SEC on November 12, 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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