Amgen Opens Up $300 Million Facility in Ireland
August 25, 2015
By Alex Keown, BioSpace.com Breaking News
DUBLIN – After five years of revamping an old Pfizer Inc. facility that included some structural expansion, California-based Amgen has opened its new $300 million facility in Dun Laoghaire, Ireland.
The site will be used as a syringe filling facility, which will be supported by a similar operation at a current plant in Dublin. The new site includes more than 25,000 square feet of production plant and more than 10,000 square feet of cold storage. The site employs 340 people, Silicon Republic reported. Pfizer sold the site in 2010. At the time it employed 280 people, Business & Leadership reported.
Amgen expects the new site to be active as it rolls out new products to support its pipeline.
“We expect to continue to introduce further new products and the site will play an important role in helping Amgen deliver for every patient, every time. We are very positive about the future,” Kerry Ingalls, Amgen’s’ vice president of site operations at Dun Laoghaire, said in the Silicon Republic article.
The Dun Laoghaire will certainly be able to support Amgen’s varied pipeline. Amgen’s new anti-cholesterol drug Repatha, a PSCK9 inhibitor, is expected to meet final regulatory approval later this month. In Phase III trials, Repatha lowered the bad cholesterol by about 60 percent and decreased the rate of cardiovascular events, including heart attack, heart failure leading to hospitalization and death, by approximately 50 percent. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
Repatha has already cleared regulatory hurdles in Europe. In May the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) authorized Repatha for the treatment of adults with certain high cholesterol issues, as well as for the treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.
Following its 2013 acquisition of Onyx Pharmaceuticals, Inc. for $10.4 billion, Amgen has been in a stronger position with 10 products either ready for regulatory approval, or in mid- to-late stage clinical development. The company has announced several successes, including with its anti-migraine drug AMG 334, which cleared its Phase II trial endpoints in April. The trial showed the drug, when compared to a placebo, lowered mean migraine days per month in patients – but only when delivered at its highest dose.
In April, the FDA granted approval to Amgen’s drug Corlanor (ivabradine) to treat patients with chronic heart failure – a drug that could bring in approximately $500 million or more in annual revenue some analysts have predicted. Amgen acquired U.S. commercial rights to Corlanor from French drugmaker Servier, which sells the medicine in Europe.
In December, the FDA also approved Blincyto, a drug designed to treat a rare form of acute lymphoblastic leukemia. Analysts predict Blincyto could generate about $400 million in annual sales, investopedia.com reported. However, the expected $178,000 price tag on the drug was worrying to some in the medical community.
Another drug Amgen has in its pipeline is Kyprolis, designed to treat multiple myeloma. Data from Phase III trials in March showed patients taking Kyprolis as part of their drug regimen lived approximately 18.7 months without their multiple myeloma worsening, which is about twice as long as patients taking Velcade, a popular treatment produced by Takeda Pharmaceuticals and Johnson & Johnson . Multiple myeloma is a blood cancer that kills more than 10,000 patients in the U.S. annually. Kyprolis patients showed fewer cases of weakness or numbness in their hands and feet, but had higher rates of cardiac and renal failure than those taking Velcade, Amgen said.
Since last year, Amgen has freed up capital from laying off about 20 percent of its workforce, part of an effort to slash $15 billion in expenses by 2018. The company has eliminated more than 4,000 global jobs from its payroll. The freed capital is expected to be used to drive additional clinical trials in an effort to get more drugs to market.