Collaboration
AstraZeneca PLC
22 December 2005
AtheroGenics and AstraZeneca Announce Late Stage Licensing and Commercialisation
Agreement for Novel Atherosclerosis Drug AGI-1067
AstraZeneca today announced that it has entered into a licensing deal with
AtheroGenics, Inc. (Nasdaq: AGIX) for the global development and
commercialisation of their anti-inflammatory cardiovascular product candidate,
AGI-1067. AGI-1067 is an investigational oral drug for the treatment of
atherosclerosis, the underlying disease process that leads to heart attacks and
strokes and is currently in Phase III development in the ARISE (Aggressive
Reduction of Inflammation Stops Events) trial.
Under the terms of the agreement AtheroGenics will receive an upfront fee of $50
million and, subject to the achievement of specific milestones including a
successful outcome in the ARISE trial, AtheroGenics will be eligible for
development and regulatory milestones of up to $300 million. The agreement also
provides for progressively demanding sales performance related milestones of up
to 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 reflect
the late stage development status and market potential of AGI-1067.
'This collaboration with AtheroGenics, is an important step in AstraZeneca's
plans to further strengthen its cardiovascular franchise,' said Dr John
Patterson, Executive Director, Development for AstraZeneca. 'We believe that
AtheroGenics' approach to partnering AGI-1067 has provided both companies with a
potential win-win situation by giving AstraZeneca exclusive access to a drug
with substantial market potential for a reasonable entry fee, while AtheroGenics
stands to benefit significantly with commercial success. AGI-1067 has the real
potential to further enhance our position among the leaders in cardiovascular
medicine.'
'We are pleased to announce this partnership with AstraZeneca, one of the
world's foremost leaders in cardiovascular medicines and other major
pharmaceutical products,' said Dr Russell M. Medford, President and Chief
Executive Officer of AtheroGenics. 'The benefit of this collaboration goes well
beyond the obvious financial rewards and gives AtheroGenics the opportunity to
access AstraZeneca's commercial expertise as we establish our own sales and
marketing group in preparation for the next phase of our corporate growth. We
and 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 additional
resources to begin its transition from a research and development organisation
to a commercial enterprise. AstraZeneca will fund, for a minimum of three years,
the formation and operation of a 125-person AtheroGenics specialty sales force
focused on the cardiology field in the US which will co-promote both AGI-1067
and one other of AstraZeneca's key cardiovascular drugs during that time.
AtheroGenics will retain responsibility for the ongoing ARISE Phase III clinical
trial and for regulatory filings in the US. AstraZeneca will have full
responsibility for pre-commercialisation activities involving the compound,
which will commence immediately, and oversee all aspects of the marketing, sales
and distribution of AGI-1067 on a worldwide basis. AstraZeneca will also be
responsible for all non-U.S. regulatory filings. Both parties will contribute
scientific and commercial expertise to the project.
Initiated in 2003 and following on from Phase II studies for AGI-1067 suggesting
regression of atherosclerotic plaque, ARISE is a multinational, double-blind,
placebo controlled study designed to assess the benefits of AGI-1067 on top of
current standard therapies in patients with coronary heart disease. Involving
more than 6000 patients in over 250 cardiac centres including the US, Canada, UK
and South Africa, this study evaluates the impact of AGI-1067 on a composite
measure of several outcome endpoints including death due to CHD, heart attack,
stroke, revascularisation and hospital admission for unstable angina. The
ARISE study is due to report in the second half of 2006.
AGI-1067 is a novel oral compound that was designed to selectively block the
inflammatory process in atherosclerosis. AGI-1067 blocks signalling pathways
within 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 in
the inflammatory process. VCAM-1 recruits inflammatory cells to the surface of
the endothelial cell, initiating the chronic inflammatory reaction that
ultimately results in atherosclerosis.
The collaboration announced today is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act.
22nd December 2005
Media Enquiries
Edel McCaffrey, Tel: +44 (0) 207 304 5034
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Investor Enquiries:
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Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506
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