AtheroGenics intends to pursue development of its lead drug candidate AGI-1067 even if AstraZeneca backs out of the development deal for the atherosclerosis compound, CEO Russell Medford stated during a March 19 business update announcing the failure of the Phase III ARISE study.

"We believe that we have the necessary financial resources to move the compound forward," he said. "At the beginning of this year, we had more than $150 million in cash, which would allow us to pursue a number of the indications we are considering on our own if necessary."

The double-blind, placebo-controlled ARISE (Aggressive Reduction of Inflammation Stops Events), in 6,100 patients with acute coronary syndrome, failed to show a significant difference over placebo in a composite primary endpoint.

"While we are obviously disappointed with the primary endpoints announced today, we believe that at this point in time, based on the results that we have reviewed, we are encouraged and optimistic that further development of 1067 is warranted in a number of therapeutic areas," Medford stated.

The primary endpoint of the study was a comparison of AGI-1067 to placebo on the time to first incidence of a composite of major adverse cardiovascular events, including cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, need for coronary revascularization and admission to hospital for unstable angina.

Detailed results of the trial were not released pending a late-breaking presentation by the Atlanta-based company at the American College of Cardiology meeting in New Orleans March 27.

AstraZeneca said it will work with AtheroGenics to fully analyze the data set before deciding whether or not to pursue development. Under the terms of the collaboration, AstraZeneca has 45 days from the time a final analysis is completed to make a development decision.

AtheroGenics, meanwhile, said it plans to complete a full analysis of the data prior to meeting with regulatory authorities to determine a path forward for the drug.

The failure of the trial to meet its primary endpoint is certainly a setback for both firms. AtheroGenics had previously announced plans to submit an NDA for AGI-1067 in the first half of the year for reduction of cardiovascular morbidity and mortality in patients with established atherosclerosis.

For AstraZeneca, positive results would have signaled a shift in the company's R&D woes. AGI-1067 is one of the company's key Phase III programs following the termination of several programs last year like NXY-059 for acute ischemic stroke, the diabetes agent Galida and others (¹ Also see "AstraZeneca Halts NXY-059 Development Following SAINT II Stroke Results" - Pink Sheet, 26 October, 2006.).

AstraZeneca and AtheroGenics announced a licensing agreement for AGI-1067 in December 2005. The U.K. drug maker paid $50 million in upfront payments and offered a potential $1 billion in milestone payments and double-digit royalties on sales (² Also see "AtheroGenics Atherosclerosis Therapy Licensed By AstraZeneca" - Pink Sheet, 23 December, 2005.).

-Jessica Merrill (j.merrill@elsevier.com)

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