Aratana Therapeutics ($PETX) announced January 5 that it has won full USDA approval for AT-004, its drug to treat B-cell lymphoma in dogs. The company believes AT-004 is the only species-specific monoclonal antibody to be fully approved for marketing in the animal health industry, it said in a press release.
AT-004 fights lymphoma by targeting the protein CD20, which is commonly expressed in B-cell lymphoma. It is a canine version of the human monoclonal antibody Rituxan, a Roche ($RHHBY) blockbuster used to treat non-Hodgkin's lymphoma in people. Dogs with the disease have traditionally been treated with standard chemotherapy, which can cause serious side effects and is often ineffective. Veterinarians will now be able to offer AT-004 as an additional choice.
"This is a serious disease and we are proud to be able to address it with a species-specific, well-validated approach," said Genevieve Hansen, head of biologics at Aratana in the release.
Novartis ($NVS) Animal Health licensed the commercialization rights to AT-004 in the U.S. and Canada--an arrangement that transferred to Eli Lilly's ($LLY) Elanco when it closed its acquisition of Novartis Animal Health last week. Elanco has not yet revealed its marketing plans for the drug. Aratana maintains all development and commercialization rights for AT-004 outside of North America.
As exciting as this milestone is for Aratana, the company is pouring much of its resources into the drugs for which it does have full commercialization rights. They include AT-005, a monoclonal antibody to treat T-cell lymphoma in dogs, which was conditionally approved by the USDA last year and is currently a candidate for full approval.
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| Steven St. Peter |
Aratana started taking orders for AT-005 in the fall, and CEO Steven St. Peter told FierceAnimalHealth at that time that the launch was going well. The company initially offered the drug to 24 veterinary clinics, with a plan to extend the rollout this year. If the drug wins full approval from the USDA, the company will be able to market it more aggressively.
Aratana has been busy bulking up its pipeline, which has yielded some positive developments of late. In late December, the company started a pivotal trial of AT-003, its injectable formulation of the pain drug bupivacaine, which Aratana licensed from Pacira Pharmaceuticals ($PCRX) and is developing to treat osteoarthritis in dogs. The company also released positive trial results for AT-001, an oral treatment for canine osteoarthritis. The company hopes to win FDA approval for both drugs and start marketing them in 2016.
- here's the release