So much for my hedging strategy. To the amazement of AGIX shorts everywhere -- and some longs -- Medford delivers a partnership:
>>ATLANTA, Dec. 22 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - News), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced that it has entered into a licensing deal with AstraZeneca for the global development and commercialization 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 commercialized, 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.
"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 Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. "The benefit of this collaboration goes well beyond the obvious financial rewards and gives us 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."
"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."
Commercialization of AGI-1067 would also provide AtheroGenics with additional resources to begin its transition from a research and development organization 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 U.S., 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 U.S. AstraZeneca will have full responsibility for pre-commercialization 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 (CHD). Involving more than 6000 patients in over 250 cardiac centers including the U.S., Canada, U.K. 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, revascularization and hospital admission for unstable angina.
The ARISE study is due to report in the second half of 2006.
The collaboration announced today is subject to clearance under the Hart- Scott-Rodino Antitrust Improvements Act.
About AGI-1067
AGI-1067 is a novel oral compound that was designed to selectively block the inflammatory process in atherosclerosis. AGI-1067 blocks signaling 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.<<
Cheers, Tuck |
