Abbott to Acquire Action Pharma's Investigational Compound, AP214, in Phase 2b Development for Prevention of Acute Kidney Injury

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May 03, 2012, 09:30 ET

ABBOTT PARK, Ill. and AARHUS, Denmark, May 3, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) and Action Pharma A/S, a privately owned company, today announced that they have entered into an agreement in which Abbott will acquire AP214 from Action Pharma.

AP214 is in development to prevent acute kidney injury (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 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.

"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, M.D., 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."

Under the terms of the agreement, Abbott will acquire all global rights to develop and commercialize AP214 for the prevention of AKI and other relevant indications. 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 A/S' (NASDAQ OMX Copenhagen: ZEAL) 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 (see separate announcement from 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.

Back Bay Life Science Advisors provided strategic advisory services for Action Pharma prior to and throughout the transaction.

About Acute Kidney Injury Associated with Major Cardiac Surgery

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.

About Action Pharma A/S

Action Pharma is a privately-owned Danish biotech company. Action Pharma has for almost ten years focused on developing novel drug candidates targeting melanocortin receptors and bring these to the stage of clinical proof of concept for subsequent partnering. Action Pharma has a strong investor base of leading European investors, including Sunstone Capital, Global Life Science Ventures, SLS Invest, InnovationsKapital, Incuba Venture, and Oestjysk Innovation. For more information, please visit www.actionpharma.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's website at www.abbott.com.

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A Caution Concerning Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors," to our Annual Report on Securities and Exchange Commission Form 10-K for the year ended Dec. 31, 2011, and are incorporated by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments.

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