Copenhagen, 2012-05-03 15:41 CEST (GLOBE NEWSWIRE) --
Company Announcement
No. 14/2012
─ The agreement will replace a previous licensing agreement with Action Pharma following Abbott’s acquisition of rights to AP214 (ZP1480) from Action Pharma
─ Related payment to Zealand Pharma of USD 11 (DKK 62) million from Action Pharma
─ Zealand Pharma entitled to royalties on Abbott’s global sales, if the product is successfully developed and marketed
Copenhagen, 3 May 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a Danish biotechnology company dedicated to the discovery and development of novel peptide drugs, announces that a license agreement has been signed with Abbott for the further development and commercialization of AP214 (referred to as ZP1480 by Zealand Pharma). AP214 (ZP1480) is a first-in-class melanocortin peptide agonist, invented and developed by Action Pharma A/S, and modified by using Zealand Pharma’s SIP®-technology.
The agreement between Zealand Pharma and Abbott replaces a prior license agreement between Zealand Pharma and Action Pharma for AP214 (ZP1480). Today, Action Pharma signed an agreement with Abbott for the acquisition of rights to AP214 (ZP1480) from Action Pharma, which triggers a payment of USD 11 (DKK 62) million to Zealand Pharma from Action Pharma.
Under the license agreement between Zealand Pharma and Abbott, Abbott will be solely responsible for the further development and commercialization of AP214 (ZP1480) for the prevention of acute kidney injury and other relevant indications. Zealand Pharma will be entitled to a low single-digit royalty on Abbott’s global future sales of AP214 (ZP1480), if the product is successfully developed, approved and commercialized.
As a closing condition, the acquisition agreement between Abbott and Action Pharma requires U.S. antitrust clearance and is expected to be completed during Q2 2012.
In September 2011, Action Pharma announced positive Phase IIb clinical results from a study of AP214 (ZP1480) in patients undergoing major cardiac surgery with cardiopulmonary bypass and who are at increased risk of developing acute kidney failure or injury. In the study, AP214 (ZP1480) reduced kidney injury and improved long-term (90 day) outcomes on a composite end point (death, dialysis and kidney function). AP214 (ZP1480) was also validated as safe and well-tolerated compared to placebo.
Abbott plans to conduct another Phase IIb study for AP214 (ZP1480) in acute kidney injury associated with major cardiac surgery.
David H. Solomon, President and CEO of Zealand Pharma, said:
“The clinical results for AP214 (ZP1480) announced to date by Action Pharma demonstrate promising efficacy and safety in patients undergoing major cardiac surgery who are at risk of developing acute kidney injury. The partnership with Action Pharma has been valuable for Zealand Pharma, and we now look forward to Abbott’s further advancing this promising peptide drug into late-stage clinical development for the benefit of patients – and with further potential value upside to Zealand Pharma and our shareholders.”
Financial outlook for 2012
The payment of USD 11 (DKK 62) million from Action Pharma in relation to the acquisition by Abbott of rights to AP214 (ZP1480) will have a positive effect on Zealand Pharma’s revenue and operating results for 2012.
Revenue from milestone payments already received and announced by Zealand Pharma in 2012 and the payment to be received from Action Pharma are expected to amount to EUR 24 (DKK 182) million, with related royalty expenses of EUR 2 (DKK 16) million. No further guidance on revenue from milestone related payments is provided for the full year at this point.
Guidance on total net operating expenses for 2012 remains unchanged at a range of EUR 20-23 (DKK 150-170) million.
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For further information, please contact:
Zealand Pharma A/S
David H. Solomon, President & CEO, Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President, Director of IR & Corporate Communication,
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
About AP214 (ZP1480)
AP214 (ZP1480) is an α-MSH peptide derivative, modified with Zealand Pharma’s proprietary SIP® technology (Structure Inducing Probe technology). AP214 has shown positive effects in preclinical disease models for the treatment and prevention of inflammation and general organ damage in conditions such as post-surgical organ dysfunction. In clinical studies, AP214 has shown to be safe and well tolerated and with positive effects in the prevention of kidney injury in patients undergoing cardiac surgery.
About Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX: ZEAL) is a biotechnology company based in Copenhagen, Denmark with a mature clinical pipeline of innovative peptide drugs. The company's lead invention is lixisenatide (Lyxumia® 1)), a once-daily GLP-1 agonist, licensed to Sanofi for the treatment of Type 2 diabetes. In November 2011, Sanofi filed for registration of lixisenatide in Europe and regulatory filing in the United States is expected in Q4 2012. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering dual acting glucagon/GLP-1 agonists, including ZP2929, for the treatment of diabetes and obesity, and a license agreement with Helsinn Healthcare on elsiglutide, a clinical stage GLP-2 drug for the prevention of chemotherapy-induced diarrhea.
Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs, and all drug candidates in its pipeline have been identified through the company's own drug discovery activities. Zealand Pharma's products target disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high.
For further information: www.zealandpharma.com.
Note 1) Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world
