Aratana Therapeutics, Inc. has announced that the United States Department of Agriculture (USDA) has granted conditional approval for AT-005, Aratana's canine-specific monoclonal antibody against CD52, which is intended as an aid in the treatment of T-cell lymphoma in dogs.
AT-005 is Aratana's second Canine Lymphoma Monoclonal Antibody to receive conditional approval and it represents Aratana's first internal commercial opportunity.
The company's canine B-cell lymphoma therapy, AT-004, received conditional approval from the USDA in 2012 and was licensed to Novartis Animal Health Inc. for commercialization in United States and Canada.
Aratana's canine-specific antibodies against CD20 (AT-004) for B-cell lymphoma and CD52 (AT-005) for T-cell lymphoma are directed against the same molecular targets as leading biologic drugs that are now the standard of care for treating human B-and T-cell lymphoma (Rituxan® and Campath®, respectively).
The paradigm shift toward adding targeted biologic therapies for treating cancer, and the success of Rituxan and Campath in particular, serve to validate and de-risk Aratana's approach to this attractive market.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "We are proud to achieve our first regulatory milestone following the acquisition of Vet Therapeutics' pet biologics platform, which brings us closer to market with our first internal commercial opportunity. Conditional approval by the USDA for AT-005 is also a major milestone for our dog lymphoma franchise as a whole, which we believe is poised to redefine the treatment of this important disease that affects millions of dogs worldwide. In parallel with initial commercialization of AT-005 by Aratana and AT-004 by our partner Novartis Animal Health, we are pursuing full licenses from the USDA for both products."
Genevieve Hansen, Ph.D., Head of Biologics at Aratana Therapeutics, stated, "Canine lymphomas, particularly T-cell, often progress very rapidly and can become fatal within weeks if left untreated. While B-cell lymphoma occurs more frequently in today's most popular dog breeds, T-cell disease is dominant in other popular breeds, and AT-005 is the first product to be approved for treating T-cell lymphoma. Now that we have achieved conditional approvals for both AT-004 and AT-005, we are helping to bring a new standard of therapy to the full spectrum of lymphoma, which is among the most common cancers in dogs."
These products are intended to be available to specialist veterinary practices, so pet owners should consult with their veterinarians about how to access this novel treatment option.
The products will be distributed under conditional license based on USDA requirements for demonstration of safety and reasonable expectation of efficacy.
Additional studies are in progress to further support the safety and efficacy of the product. Production under this license is in compliance with all regulations and standards applicable to such products.