BioWorld International Correspondent

The fallout from Amgen Inc.'s woes spread to Ireland last week, as the company said it would "postpone indefinitely" plans to build a $1 billion biologics production facility at Carrigtwohill, near Cork City.

The move is a major blow for IDA Ireland, the state agency responsible for promoting inward investment, since winning the Amgen project over competing bids from Singapore and Switzerland was touted as its biggest success in 2006 across any industrial sector.

Thousand Oaks, Calif.-based Amgen originally had disclosed plans to build process development, bulk manufacturing and fill and finish facilities on a 133-acre campus at the beginning of 2006. The project would have doubled its fill and finish capacity and increased its bulk manufacturing capacity by 50 percent. Under the original plan, the plant was to have employed 1,100 workers by 2010. The schedule was moved out to 2012 in the spring of this year, following new data that indicated cancer patients on Aranesp (darbepoetin alfa) who were not undergoing chemotherapy had an increased risk of death.

Despite the prevailing uncertainty, the project appeared to have survived the cutbacks Amgen announced on Aug. 15, in the wake of falling Aranesp sales. As recently as two weeks ago, one company official was making optimistic noises about the project, Barry O'Leary, senior vice president of operations at IDA Ireland, told BioWorld International. The company's withdrawal from the project is therefore, "very disappointing," he said, although he added it is not linked in any way to the prevailing climate in Ireland. "There is no project full-stop. It has evaporated."

Some 79 staffers are employed on the project at present, 65 of whom are based in Cork. Some may be redeployed elsewhere within the company, but most will be offered redundancy packages, Amgen said.

Ireland has for several decades acted as a base for traditional pharmaceutical manufacturing and has attracted nine of the industry's top 10 firms through a combination of direct grants and a corporate tax rate of 12.5 percent. More recently, it has been attempting to extend its position into biologics manufacturing, and it has secured substantial biotech projects with Madison, N.J.-based Wyeth, Genzyme Corp. and Eli Lilly & Co. "There's a couple more that we're playing for at the moment," O'Leary said.

The agency is bidding for corporate research and development investment from its pharma and biotech clients. Most of this involves the addition of process development functions to existing production sites, but last week it disclosed an academic research collaboration on Alzheimer's disease involving the Neurology Centre of Excellence for Drug Discovery at London-based GlaxoSmithKline plc, the Trinity College Institute of Neuroscience (TCIN) at Trinity College, Dublin, and the National University of Ireland, Galway. The agency is providing an undisclosed element of the initiative's €14.6 million (US$20.6 million) budget over the next five years.

The plan, said Shane O'Mara, deputy director of the TCIN and principal investigator on the research collaboration, is to perform translational studies that will integrate data on cognitive functioning with brain imaging and electroencephalographic measurements of the brain's electrical activity.

Data from healthy controls will be compared with data from those with mild cognitive impairment and those who are clinical diagnosed as having Alzheimer's, in order to gain insights into the early progression of the disease. "One of the major problems we've got in the field at the moment is the ability to diagnose prognostically whether or not you will get a neurodegenerative disease," O'Mara told BioWorld International. The partners will also test preclinical GSK drug candidates in cellular and animal models of Alzheimer's.

The initiative is the second such deal GSK has signed in Ireland. Last year, it entered a €13.7 million research collaboration on gastrointestinal disease at the Alimentary Pharmabiotic Centre at University College Cork.

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