Aratana secures third FDA approval

Results on the financial and animal therapeutic front have been very good this year

The future is much brighter at Aratana Therapeutics Inc.

The Leawood, Kan., company this week won U.S. government approval of its third veterinary biopharmaceutical, Nocita (bupivacaine liposome injectable suspension).

The first two products—the canine osteoarthritis drug Galliprant and the appetite stimulant Entyce—earned endorsement this past spring from the U.S. Food and Drug Administration’s Center for Veterinary Medicine.

The string of regulatory successes means a financial turnaround is within sight at the six-year-old company. Aratana, which registered a 2015 loss of $84.1 million, has remained solvent as investors confident about its therapeutic pipeline continue to plow money into research and development.

Aratana signed a licensing deal in April with Elanco Animal Health of Greenfield, Ind., for the manufacture and sale of Galliprant (grapiprant tablets) beginning this fall. The contract brought an upfront payment of $45 million, leading to second-quarter net income of $21.2 million.

“Our vision is to become a fully integrated company,” said CEO and President Steven St. Peter, M.D. “As our team celebrates significant development and regulatory milestones, we are pivoting to build our sales organization to support the launches of our approved therapeutics.”

Nocita, also scheduled for a fall release, is indicated for the control of pain after cranial cruciate ligament surgery in dogs. The injectable anesthetic is formulated to work for up to 72 hours “by releasing bupivacaine over time from multivesicular liposomes deposited in the tissue,” Aratana noted.

“We believe Nocita will help transform the way veterinarians control post-operative pain for dogs undergoing cranial cruciate ligament surgery,” St. Peter said.

The therapeutic is not to be used in dogs less than 5 months old or in dogs used for breeding or that are pregnant or lactating, the company stated.

Entyce (capromorelin oral solution) is scheduled for release in February 2017 during the annual NAVC conference.

The trio of FDA approvals followed the failure of two therapeutics licensed by the U.S. Department of Agriculture. Poor sales led to the abandonment a year ago of products formulated to treat B-cell and T-cell lymphoma in dogs.

Aratana stated at the time that it could not rule out the development of second-generation monoclonal antibodies for the treatment of canine lymphoma.

Still under development are:

  • AT-003 for post-operative pain management in cats.
  • AT-006, an investigational therapeutic for feline herpes virus-induced ophthalmic conditions.
  • AT-014, an investigational canine osteosarcoma vaccine licensed from Advaxis Inc.
  • AT-016 for dogs with osteoarthritis pain. The licensing partner is VetStem Biopharma of Poway, Calif.

Post a Comment