Abbott, a global, broad-based health care company, has entered into an agreement with a privately-owned Danish biotech company, Action Pharma A/S, to acquire all global rights to develop and commercialize investigational compound, AP214 for prevention of acute kidney injury (AKI).

Under the terms of the agreement, Abbott will provide a cash payment of $110 million to Action Pharma and will be responsible for funding all future development and commercialization activities regarding AP214. No later milestone payments or royalties will be paid to Action Pharma. Abbott expects to incur a one-time specified item in the second quarter of 2012, related to this payment.

AP214 is in development to prevent AKI associated with major cardiac surgery in patients at increased risk and has further potential in adjacent indications. AP214 is a hormone analogue that targets both systemic inflammation and cellular death (apoptosis) caused by hypoxia (lack of blood flow) that can occur during surgery. In September 2011, Action Pharma announced positive Phase 2b top-line results evaluating the efficacy, safety and tolerability of AP214. Abbott plans to conduct another Phase 2b study, which is expected to begin later this year.

This acquisition will enhance Abbott's pipeline in renal care. Abbott has two investigational treatments in development for chronic kidney disease (CKD). Bardoxolone, a first-in-class anti-oxidant inflammation modulator that activates Nrf2, a pathway involved in the progression of CKD, is in phase III development with Reata Pharmaceuticals. Atrasentan, a compound discovered by Abbott scientists, is being evaluated in a phase II b study in patients with diabetic kidney disease.

“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, a long-standing unmet need in the medical community,” said John Leonard, MD, senior vice president, pharmaceuticals, research and development, Abbott. “This acquisition complements and broadens Abbott's late-stage renal care pipeline and builds on our existing experience in treating kidney disease.”

“We are very excited about the sale of AP214 to such a prominent global health care company as Abbott, which has key development competencies to continue the development of this drug candidate for the benefit of patients and physicians in the renal therapeutic area,” said Ingelise Saunders, CEO of Action Pharma. “We also wish to thank our shareholders for their continued support of Action Pharma.”

Acute kidney injury (AKI) is known to be associated with increased short- and long-term mortality and co-morbidity, as well as prolonged hospitalization and permanent decline in renal function. Currently there are no pharmaceuticals on the market for the treatment or prevention of AKI associated with major cardiac surgery.

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