AstraZeneca, Amgen Crohn's drug runs into PhII 'logistical' snafu

One of the programs involved in AstraZeneca's ($AZN) $50 million bid to collaborate with Amgen on the development of a slate of biologics has run into a snafu of some sort. Late last summer investigators reported that a pair of mid-stage trials of AMG 181 for ulcerative colitis and Crohn's disease had been suspended, just after an early-stage trial was reported terminated.

According to Clinicaltrials.gov, a trial registry run by the National Institutes of Health, Amgen ($AMGN) reported late last August that one of the Phase II studies, a 360-patient trial that launched last November, had to be suspended, noting that an "inaccuracy in study documents required correction for future enrollees." The same reason was given for the suspension of another placebo-controlled trial that aimed at recruiting 252 patients.

FierceBiotech was tipped off to the trial suspensions by someone familiar with the program. But aside from a short statement unadorned by any detail, neither company had much to add by way of comment.

"The trial has been temporarily suspended due to logistical issues; however, we (Amgen/AZ/MedI) are working to re-start it as quickly as possible," responded AstraZeneca and Amgen. FierceBiotech followed up with a series of questions but did not hear back immediately from either of the biopharma giants.

When AstraZeneca stepped up in April 2012 with its $50 million upfront and a commitment to cover the lion's share of the near-term R&D costs, it also took the reins on AMG 181, 139 and 157, with Amgen retaining control of AMG 557 and brodalumab (AMG 827). At the time, AstraZeneca CEO David Brennan and former R&D chief Martin Mackay were trying to prove that they could reform the company, widely blasted for having the weakest pipeline in the Big Pharma field. Analysts cheered the creative deal, which expanded AstraZeneca's pipeline and provided Amgen with a deep-pocket partner to help advance its assets, sharing the risk while willing to give up some of the potential rewards.

After Pascal Soriot took the helm at AstraZeneca later in 2012, MedImmune was given control of biologics development through mid-stage studies, with Bahija Jallal in the driver's seat at the Gaithersburg, MD-based company.

AstraZeneca faces two of the biggest patent losses in the industry next year, when Nexium and Symbicort--with combined 2012 sales of $7 billion--lose protection against generics. That has left a few analysts fretting about its ability to advance therapies into a still-weak late-stage pipeline. Amgen, on the other hand, recently wrapped the buyout of Onyx ($ONXX), which adds to its portfolio of cancer drugs.

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