Abbott is paying Denmark’s Action Pharma $110 million for global rights to develop and commercialize the latter’s AP214, a Phase II-stage alpha-MSH peptide derivative currently in development for preventing acute kidney injury associated with major cardiac surgery in at-risk patients. Under terms of the deal Abbott acquires rights to AP214 for all potential indications, and will be responsible for all future development and commercialization activities. No further milestones or royalty payments will be due to Action.
AP214 has been developed using Zealand Pharma’s Structure Inducing Probe (SIP®) technology under a license agreement for the technology signed in 2003. The deal between Action and Abbott has triggered an $11 million milestone payment from Action to Zealand, and the latter will also be eligible to receive low single-digit royalty payments on Abbott’s future sales of the drug. The SIP tail technology is a method for adding specified amino acids to a peptide to strengthen or tighten its molecular structure, and increase half life in the body by making the molecule less susceptible to biological degradation.
In September 2011 Action reported positive data from a Phase IIb study in patients undergoing cardiac surgery with cardiopulmonary bypass who were at increased risk of developing acute kidney failure or injury. The results confirmed that AP214 reduced kidney injury and improved long-term outcomes on a composite endpoint of death, dialysis, and kidney function. Abbott aims to initiate another Phase IIb study later this year.
“Clinical experience with AP214 in cardiac surgery patients suggests that it has the potential to be the first compound specifically approved to prevent acute kidney injury,” comments John Leonard, Ph.D., svp for pharmaceuticals, R&D at Abbott. “This acquisition complements and broadens Abbott’s late-stage renal care pipeline and builds on our existing experience in treating kidney disease.”
The firm has two chronic kidney disease candidates in its clinical pipeline. Bardoxolone is an Nrf2-activating antioxidant inflammation modulator undergoing Phase III development in partnership with Reata Pharmaceuticals. Abbott’s in-house candidate Atrasentan is a selective endothelin A receptor antagonist undergoing Phase IIb trials in patients with diabetic kidney disease.