Aratana Therapeutics Offers Update on Monoclonal Antibody Products

Aratana Therapeutics, Inc.

, 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."