Washington Editor

Amgen Inc. has postponed "indefinitely" plans for a $1 billion process development, bulk manufacturing and fill-and-finish plant in Ireland.

The Thousand Oaks, Calif.-based firm said an "evolving business environment" led to the decision.

"This decision is based purely on developments relating to Amgen's global business and is in no way reflective of the business environment in Ireland or of the high caliber staff we have hired," said Mark Sawyer, general manager and vice president of operations for Amgen Technology Ireland.

Amgen said it will cease all activities on the Irish site. However, the firm said it plans to maintain ownership of the site, which is in Carrigtwohill, County Cork.

The decision, the company said, will affect up to 79 employees, 65 of whom live in the Carrigtwohill area. Amgen said it is likely that the majority of those employees will be offered "redundancy packages."

Ceasing activity in Ireland, Amgen said, will not affect the firm's ability to supply patients.

Michael Martin, Irish minister for enterprise, trade, and employment, called Amgen's decision disappointing and reassured County Cork residents that the government remained committed to attracting inward investment into the community.

Amgen announced plans for the Irish plant in January 2006, stating that the facility would produce products for the "growing number of patients in Europe and other parts of the world who benefit from Amgen's vital medicines." The Irish facility was expected to begin operating in 2009 and employ more than 1,100 people, according to a Jan. 24, 2006 statement.

Amgen said it chose Ireland for the $1 billion plant because of its "thriving biotechnology community, infrastructure to support biologics manufacturing and attractive business climate."

The Irish plant, Amgen said in 2006, was part of the firm's major global expansion of its R&D efforts "in a number of scientific hubs throughout the world."

The company had announced plans to expand its R&D operations in Massachusetts, San Francisco, Seattle, and the UK and add a new manufacturing plant in Puerto Rico to produce Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).

"This global expansion is due to a remarkably robust pipeline that is driving Amgen's growth and helping build a portfolio that rivals any in the industry," the firm stated in January 2006.

But sales of Epogen and Aranesp dropped sharply in 2007 after the FDA in March called for a black-box warning in product labeling and the Centers for Medicare & Medicaid Services (CMS) in July decided to limit payments for the drugs, known as erythropoiesis-stimulating agents (ESAs), when used in cancer patients. (See BioWorld Today, March 12, 2007 and Aug. 1, 2007.)

On Aug. 15, Amgen announced that it was cutting jobs for up to 2,600 employees, or about 14 percent of its workforce, due to lower sales of Aranesp (See BioWorld Today, Aug. 16, 2007.) It also reduced planned capital expenditures by about $1.9 billion over the next year and planned to close certain production operations and was "rationalizing other facilities to achieve improved efficiencies."

Speculation circulated earlier this week in Seattle that Amgen also planned to delay expansion of its office, laboratory and warehouse campus there. But Amgen spokesperson Mary Klem told BioWorld Today that the firm has made no announcements to date about how its restructuring plans may affect the Seattle operation.

She noted that Amgen recently "decommissioned" the older of its two plants in Rhode Island where the firm's rheumatoid arthritis drug Enbrel (etanercept) is made by its subsidiary Immunex Corp.

"We are having to make a lot of difficult decisions," Klem said.

Last week, U.S. Reps. Anna Eshoo (D-Calif.) and Mike Rogers (R-Mich.) introduced a bill that would require CMS to reverse its July decision to limit payments for ESAs in cancer patients.

In a Sept. 24 letter to physician groups, CMS said it needed more proof before it would reconsider its July decision. (See BioWorld Today, Sept. 26, 2007.) Oncologists and hematologists have complained that CMS's rule to restrict payments for ESAs interferes with physicians' ability to provide the best possible patient care.

The FDA currently is considering whether to add more warnings to the labeling of ESA products, which includes Procrit (epoetin alfa), marketed by Johnson & Johnson subsidiary Ortho Biotech under an agreement with Amgen. A decision is expected to be announced this month.

New commercial deal

Separately, Amgen and its Italian marketing partner Dompe Biotec SpA said Thursday that they are combining commercial operations in Italy to form Amgen-Dompe, which will operate as an affiliate of Amgen. The newly formed business will comprise of Amgen and Dompe staff plus current Amgen R&D staff in Italy.

Dompe CEO Eugenio Aringhieri has been named president of Amgen-Dompe and Marco Renoldi, who is currently managing director of Amgen Italy, will serve as its managing director. The new operation's board will consist of four Amgen members and three Dompe members, Amgen stated.

"This new arrangement will make our operations in Italy stronger and better organized to achieve sustained long-term growth and continued commitment to excellence in service to patients," said Rolf Hoffmann, senior vice president of Amgen International Commercial Operations.

Dompe Biotec, established in 1988, specializes in marketing of biotech drugs with a high therapeutic profile in the oncological, hematological and nephrological areas.