22nd Dec 2005 14:40
AstraZeneca PLC22 December 2005 AtheroGenics and AstraZeneca Announce Late Stage Licensing and CommercialisationAgreement for Novel Atherosclerosis Drug AGI-1067 AstraZeneca today announced that it has entered into a licensing deal withAtheroGenics, Inc. (Nasdaq: AGIX) for the global development andcommercialisation of their anti-inflammatory cardiovascular product candidate,AGI-1067. AGI-1067 is an investigational oral drug for the treatment ofatherosclerosis, the underlying disease process that leads to heart attacks andstrokes and is currently in Phase III development in the ARISE (AggressiveReduction of Inflammation Stops Events) trial. Under the terms of the agreement AtheroGenics will receive an upfront fee of $50million and, subject to the achievement of specific milestones including asuccessful outcome in the ARISE trial, AtheroGenics will be eligible fordevelopment and regulatory milestones of up to $300 million. The agreement alsoprovides for progressively demanding sales performance related milestones of upto a further $650 million. In total, if successfully commercialised,AtheroGenics will be eligible for fees and milestones of up to $1 billion.AtheroGenics will also receive stepped royalties on product sales, which reflectthe late stage development status and market potential of AGI-1067. "This collaboration with AtheroGenics, is an important step in AstraZeneca'splans to further strengthen its cardiovascular franchise," said Dr JohnPatterson, Executive Director, Development for AstraZeneca. "We believe thatAtheroGenics' approach to partnering AGI-1067 has provided both companies with apotential win-win situation by giving AstraZeneca exclusive access to a drugwith substantial market potential for a reasonable entry fee, while AtheroGenicsstands to benefit significantly with commercial success. AGI-1067 has the realpotential to further enhance our position among the leaders in cardiovascularmedicine." "We are pleased to announce this partnership with AstraZeneca, one of theworld's foremost leaders in cardiovascular medicines and other majorpharmaceutical products," said Dr Russell M. Medford, President and ChiefExecutive Officer of AtheroGenics. "The benefit of this collaboration goes wellbeyond the obvious financial rewards and gives AtheroGenics the opportunity toaccess AstraZeneca's commercial expertise as we establish our own sales andmarketing group in preparation for the next phase of our corporate growth. Weand AstraZeneca both look forward to the upcoming ARISE clinical trial results,which will be instrumental in defining the future of the collaboration." Commercialisation of AGI-1067 would also provide AtheroGenics with additionalresources to begin its transition from a research and development organisationto a commercial enterprise. AstraZeneca will fund, for a minimum of three years,the formation and operation of a 125-person AtheroGenics specialty sales forcefocused on the cardiology field in the US which will co-promote both AGI-1067and one other of AstraZeneca's key cardiovascular drugs during that time. AtheroGenics will retain responsibility for the ongoing ARISE Phase III clinicaltrial and for regulatory filings in the US. AstraZeneca will have fullresponsibility for pre-commercialisation activities involving the compound,which will commence immediately, and oversee all aspects of the marketing, salesand distribution of AGI-1067 on a worldwide basis. AstraZeneca will also beresponsible for all non-U.S. regulatory filings. Both parties will contributescientific and commercial expertise to the project. Initiated in 2003 and following on from Phase II studies for AGI-1067 suggestingregression of atherosclerotic plaque, ARISE is a multinational, double-blind,placebo controlled study designed to assess the benefits of AGI-1067 on top ofcurrent standard therapies in patients with coronary heart disease. Involvingmore than 6000 patients in over 250 cardiac centres including the US, Canada, UKand South Africa, this study evaluates the impact of AGI-1067 on a compositemeasure of several outcome endpoints including death due to CHD, heart attack,stroke, revascularisation and hospital admission for unstable angina. TheARISE study is due to report in the second half of 2006. AGI-1067 is a novel oral compound that was designed to selectively block theinflammatory process in atherosclerosis. AGI-1067 blocks signalling pathwayswithin the endothelial cells that make up the inner lining of blood vessels,which in turn inhibits the production of VCAM-1 and other molecules involved inthe inflammatory process. VCAM-1 recruits inflammatory cells to the surface ofthe endothelial cell, initiating the chronic inflammatory reaction thatultimately results in atherosclerosis. The collaboration announced today is subject to clearance under theHart-Scott-Rodino Antitrust Improvements Act. 22nd December 2005 Media EnquiriesEdel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 - ends - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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