Amgen关闭EPO科罗拉多原料廠.. 485名员工????

安进将关闭科罗拉多促红细胞生成素Epogen生产厂 发布时间：2012-8-16 来源：药品资讯网信息中心据美国媒体最新资讯，美国安进制药公司（Amgen）日前表示，公司计划关闭其在科罗拉多州朗蒙特（Longmont）地区的生产厂，主要是因为该厂生产的促红细胞生成素药物销售收入有所下滑。据安进制药公司表示，未来12月~15月之内，该厂的所有生产项目将宣布终止，这个生产厂旗下485名员工正在等待安排，决定最终去向。 安进制药公司的另外一个生产厂位于科罗拉多州博尔德市，该生产厂旗下共有240名员工，主要生产治疗骨质疏松症、关节炎和癌症药物狄诺塞麦（denosumab），目前该厂并未受到影响。据悉，安进制药公司科罗拉多州朗蒙特地区的生产厂主要负责生产促红细胞生成素阿法依泊汀（Epogen）的散装原料成分，该药物目前已经获批用作慢性肾脏病和癌症的辅助治疗手段，但是近期该药物的市场销售收入持续下滑。今年三月份，Affymax制药公司和日本武田制药公司携手研制的Omontys获批上市销售，成为Epogen的市场竞争对手，引致今年上半年Epogen的市场销售总额下跌至9.71亿美元，较以往同期下降10%。与此同时，2010年时Epogen出现了安全问题，直接导致需求下降。安进制药公司此前推出的治疗贫血药物Aranesp（安然爱斯普）也受到了相关影响，今年上半年的销售收入下降至10.5亿美元，跌幅10%。而安进制药公司在波多黎各（位于西印度群岛东部的岛屿）的Juncos生产厂则负责生产Aranesp的原料药。据安进制药公司透露，2010年，Epogen带来了高达25亿美元的收入，但是去年该药物的收入下降至20亿美元，而安进制药公司称，品牌实力将继续维持Epogen（阿法依泊汀）药物的市场竞争地位，但是考虑到当前市场发展较为脆弱，安进制药公司不得不宣布通过降低成本投入来维持Epogen的市场盈利性。据悉，明年Epogen药物在美国的市场专利保护即将到期，届时仿制药市场竞争压力将日趋渐现，这也是安进制药实行成本控制的原因之一。当地媒体报道，尽管安进制药公司已经宣布关闭其在朗蒙特地区的生产厂，但是该厂的质量控制、工艺流程和研发服务等尚未处理，安进制药公司也未表示最终的处理办法。未来数月之内，安进制药朗蒙特生产厂的产能将实现最后一次上涨，然后关闭并且闲置。

Amgen unveils plan to close Epogen plant Published on 14/08/12 at 09:38am Amgen has said it will close down a manufacturing facility in Longmont, Colorado, in the face of declining sales of its red blood cell-boosting treatments. The plant will cease operations in the next 12 to 15 months, with the 485 people employed there now waiting to hear whether they will be offered employment elsewhere in the Amgen group. The nearby LakeCentre facility in Boulder - which employs around 240 staff and manufactures products such as osteoporosis, arthritis and cancer treatment denosumab - is unaffected by the cutbacks. The bulk ingredient for Epogen (epoetin alfa) is the only product made by Amgen at Longmont, and sales of the drug - used as a supportive therapy in patient with cancer or chronic kidney disease - have been in decline. In the first half of this year Epogen sales fell 10% to $971 million as a result of new competition from Affymax/Takeda's Omontys (peginasetide) - which was approved for marketing in the US in March - but also safety concerns which emerged in 2010 and have pegged back demand. Amgen's long-acting variant Aranesp (darbepoetin alfa) has also been affected, with sales down by 10% to $1.05 billion in the first half. The bulk active for Aranesp is made in Amgen's Juncos plant in Puerto Rico. Sales of Epogen were $2.5 billion in 2010 but fell to $2.0 billion last year. The company has insisted that its brand strength will help Epogen remain a key product in the marketplace, but the latest decision suggests it is trying to reduce costs in order to retain profitability from the epoetin franchise. A key factor in the decision is likely to be the upcoming expiry of epoetin alfa's patent protection in the US next year, opening the door for biosimilar competitors from the likes of Novartis/Sandoz, Roche and Hospira. Meanwhile, Amgen has been trying to defend its epoetin alfa products from Omontys by signing supply contracts with DaVita and Fresenius, the two biggest dialysis clinic chains in the US. Local media reports indicate that while the production elements of the Longmont facility will be closed, operations there which provide quality control and process engineering and development services across the Amgen group will be retained. At present it is not clear whether these will remain at Longmont or be moved elsewhere. Production will ramp up over the coming months and then cease and the plant will be idled, said a report in the Longmont Times.