With patent clock ticking, Amgen plans to shutter Epogen plant

In a major milestone for its anemia franchise, Amgen ($AMGN) is preparing to idle production at its only bulk Epogen plant. The Longmont, CO, facility will remain open, handling quality control and process development for other drugs, but some of its 485 workers will lose their jobs.

An Amgen spokeswoman told the Longmont Times-Call that the shutdown marks a change in the company's manufacturing strategy. The plant will ramp up production of the Epogen active ingredient over the next year or so, and then production there will cease. The spokeswoman says it's not yet clear how many jobs will be cut.

Other reasons for the stoppage aren't difficult to identify. Epogen and its sister drug Aranesp have never recovered from the safety issues that arose in 2010, when higher doses were linked to all sorts of serious side effects, including death. FDA added warnings to the drugs' labels and Medicare limited reimbursements to discourage the higher doses. But more importantly, Epogen loses its patent protection next year, and now that there's a pathway for biosimilar drugs, it's sure to face competition.

Several drugmakers have been working on versions of Epogen, known generically as epoetin alfa, for years. Novartis ($NVS) has been selling a knockoff in Europe, under the brand name Binocrit, since 2007. Roche's ($RHHBY) Mircera was close enough that a U.S. court enjoined the Swiss drugmaker from selling it till mid-2014. (The patents on Aranesp, a.k.a. darbapoetin alfa, don't expire till then.) Hospira ($HSP) began a Phase III trial of its version in January.

Plus, Affymax ($AFFY) recently won approval for a head-to-head rival, Omontys, known generically as peginesatide. The Affymax drug is only dosed once a month, versus multiple doses for Epogen. The company recently won a contract with dialysis provider Fresenius Medical Care to provide Omontys for its patients.

For its part, Amgen has also been securing long-term contracts for Epogen and Aranesp in advance of the patent expirations. It has a 7-year exclusive deal with DaVita to supply at least 90% of its drugs for dialysis patients, and a three-year non-exclusive with Fresenius.

The Longmont plant will wind down over the next 12-15 months and the Epogen building will close, but remain ready to go if Amgen needs to ramp up again. Local economic development officials fear that most of the 485 jobs will be cut. "[A]s far as I know, the majority of their work force (in Longmont) is related to the manufacture of Epogen," Longmont Area Economic Council CEO John Cody told the Times-Call.

- read the Times-Call story

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