Aratana Therapeutics Provides Update on Monoclonal Antibody Products
KANSAS CITY, Kan., July 22, 2015 /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 provided an update on the development, manufacturing and commercialization of their monoclonal antibodies (MAbs) targeting canine B-cell lymphoma (AT-004) and canine T-cell lymphoma (AT-005). AT-004 has received full licensure from the United States Department of Agriculture (USDA), and AT-005 has received conditional licensure from the USDA and Aratana continues to anticipate full licensure in 2015.
Aratana has completed enrollment in its second multi-center, blinded, placebo-controlled, randomized study designed to assess adding AT-005 to a multi-agent chemotherapy protocol for dogs with T-cell lymphoma (T-LAB). In June 2015, the company completed enrollment in T-LAB with a total of approximately 60 client-owned dogs with intermediate to high grade T-cell lymphoma. In January 2015, the first study, T-CHOMP, was fully enrolled with a total of approximately 50 client-owned dogs. Results from both studies are expected by mid-2016.
Aratana continues to make AT-005 commercially available through a T-cell Clinical Experience Program (T-CEP). The practices participating in T-CEP receive a 30% discount on AT-005 in exchange for data associated with their lymphoma treatments and outcomes. At the end of June 2015, there were approximately 70 active sites and approximately two hundred lymphoma cases enrolled in T-CEP. Aratana intends to maintain the current number of T-CEP sites until late-2016 when Aratana anticipates that it will have sufficient manufacturing capacity to accommodate additional sites.
Aratana recently regained the commercialization and manufacturing rights for AT-004, and prior to July 2015, AT-004 had only been available in limited quantities for compassionate use. The company will be initiating an approximately 60 client-owned dog study in July 2015 to compare the effectiveness of two cycles of CHOP plus B-cell MAb against historical benchmarks for a standard of care CHOP protocol ("mini B-CHOMP"). Aratana expects to report the initial results of B-CEP and the mini B-CHOMP study results in mid-2016. The company anticipates that results from mini B-CHOMP will complement the three independent investigator initiated studies in other settings that have already been reported.
After mini B-CHOMP is fully-enrolled, Aratana intends to make AT-004 available on a rolling regional basis as part of a B-cell Clinical Experience Program (B-CEP). Similar to the T-CEP program, the B-CEP program will allow a 30% discount on AT-004 in exchange for data associated with lymphoma treatments and outcomes. However, Aratana anticipates that it will remain manufacturing constrained on AT-004 until late-2016.
In addition to the clinical studies, Aratana continues to conduct certain scientific studies with the MAbs. In particular, Aratana is working to better understand the specificity of its MAbs in an in-vivo setting.
Aratana continues to expand the manufacturing capacity needed to supply the broader canine lymphoma market while it completes the scientific and post-marketing studies for AT-004 and AT-005. In connection with the facility expansion project, the USDA recently completed an inspection of the company's facility in San Diego, which is the single manufacturer of AT-004 and AT-005. Aratana is also working with a third party USDA-licensed manufacturer to establish a second manufacturing site. Aratana expects a limited commercialization through the T-CEP and B-CEP programs until late 2016 at which time a full commercial launch is anticipated.
Aratana continues its research and development efforts on other monoclonal antibodies in oncology and other therapeutic areas, including MAbs for cats.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "Our innovative products for the treatment of lymphoma continue to generate high interest by the veterinary community, and we are very encouraged. We remain committed to the oncology market and the investment and time it will take to complete the scientific, clinical and manufacturing work to fully realize the potential of these products."
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 USDA and/or FDA and the licensure and approval of products; development programs; clinical trials and studies, including without limitation the announcement of results of such trials and studies; commercialization and manufacturing of products, including without limitation establishing larger manufacturing capacities for AT-004 and AT-005; in-licensing initiatives and collaborations; the Company's plans and opportunities, including without limitation offering innovative therapeutics; and the Company's belief that its products and product candidates will result in improved outcomes for pets.
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; uncertainties regarding the outcomes of studies regarding our products; 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, partners and other third parties which conduct our target animal studies and certain other development efforts; 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 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.
SOURCE Aratana Therapeutics, Inc.