Date: 2012-05-03
Type of information: Licensing agreement
Compound: AP214
Company: Abbott (USA) Action Pharma (Denmark)
Therapeutic area: Kidney diseases - Renal diseases
Type agreement: licensing
development
commercialisation
Action mechanism: 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.
Disease: prevent acute kidney injury associated with major cardiac surgery and other relevant indications
Details: Abbott and Action Pharma have entered into an agreement in which Abbott will acquire AP214 from Action Pharma. Under the terms of the agreement, Abbott will acquire all global rights to develop and commercialize AP214 for the prevention of acute kidney injury and other relevant indications.
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 3 development with Reata Pharmaceuticals. Atrasentan, a compound discovered by Abbott scientists, is being evaluated in a Phase 2b study in patients with diabetic kidney disease.
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.
Financial terms: 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.
In 2003, Action Pharma in-licensed Zealand Pharma' SIP® technology for use with pro-opiomelanocortin derivatives. As part of the agreement between Abbott and Action Pharma, Action Pharma\'s original licensing agreement with Zealand Pharma regarding the SIP® technology is cancelled, and superseded with a new agreement between Abbott and Zealand Pharma regarding the SIP® technology. Upon the closing of the Abbott and Action Pharma transaction, Action Pharma will make a one-time payment to Zealand Pharma of $11 million. Zealand Pharma will also be entitled to a low single-digit royalty on Abbott's future global sales of AP214 (referred to as ZP1480 by Zealand Pharma). Since 2003, Action Pharma has solely developed AP214 to its current clinical status.
Latest news: * On June 19, 2012, Zealand Pharma has announced the final closing of the company’s license agreement with Abbott for the development and commercialization of AP214 (referred to as ZP1480 by Zealand Pharma) as described above. The final closing follows the receipt of U.S. Antitrust clearance of the agreement between Action Pharma and Abbott on the acquisition by Abbott of all rights to AP214 from Action Pharma. As part of the closing of the license agreement with Abbott, Zealand Pharma has received payment of USD 11 (DKK 66) million from Action Pharma as announced.
