Pugsley M K
Department of Pharmacology, Xoma (US) LLC, Berkeley, CA 94710, USA.
Curr Opin Investig Drugs. 2001 Dec;2(12):1725-31.
Immunex has developed and launched etanercept, a soluble TNF receptor (TNFR) fusion protein, for the treatment of rheumatoid arthritis (RA). It has also been developed for various TNF-mediated conditions such as congestive heart failure, endometriosis and multiple sclerosis. Etanercept has been launched as a second-line agent in the US for the treatment of moderate-to-severe RA and can be used in conjunction with methotrexate in patients unresponsive to methotrexate alone. It is also available in the EU. In 2000, it was in phase III trials for psoriatic arthritis and an NDA filing for this indication was expected for the first half of 2001. In July 2001, the sBLA was filed, and in September 2001, the FDA granted the sBLA Priority Review status. As of January 2001, etanercept was in phase III trials for congestive heart failure, with sNDA filing expected in 2002; however, by March 2001, these had been halted, as it did not appear that statistical significance would be reached for the efficacy endpoints. Further data analysis was being undertaken at this time, before a final decision was taken. In April 2001, Merrill Lynch reported that development for this indication was to be halted. Sales for the drugs first full quarter on the market in 1999 were US $59.7 million. By November 1999 the drug had made sales of US $500 million; Immunex expected the drug to generate over US $2 billion in annual sales by 2004. In September 2000, Merrill Lynch reported that if sales of the drug continued at the present rate then it is likely that demand would temporarily outstrip supply in 2001. Resolution of the supply issue was expected by 2002. Also in September 2000, Merrill Lynch lowered their estimate of sales in 2001 from US $1 billion to $927 million. In the long-term, Merrill Lynch believed that the drug has the potential to exceed US $5 billion in sales in the US. In April 2001, Merrill Lynch predicted that etanercept prescribed for RA would generate sales of US $71 in 2002 rising to US $600 million in 2005. In October 2001, Morgani Stanley reported that Enbrel continues to be the primary source of revenue of Immunex (US $198.1 million). It was also reported that if launched for CHF, an estimated peak year revenue was likely to be US $500 million. The company maintains a website containing additional information about etanercept at http://www.enbrelinfo.com.
免疫ex公司已研发并推出了依那西普，一种可溶性肿瘤坏死因子受体（TNFR）融合蛋白，用于治疗类风湿性关节炎（RA）。它也被开发用于治疗各种由肿瘤坏死因子介导的病症，如充血性心力衰竭、子宫内膜异位症和多发性硬化症。依那西普在美国已作为二线药物推出，用于治疗中度至重度类风湿性关节炎，并且可与甲氨蝶呤联合用于对单独使用甲氨蝶呤无反应的患者。它在欧盟也有供应。2000年，它正处于银屑病关节炎的III期试验，预计2001年上半年会提交针对该适应症的新药申请（NDA）。2001年7月，提交了补充生物制品许可申请（sBLA），2001年9月，美国食品药品监督管理局（FDA）授予该sBLA优先审评地位。截至2001年1月，依那西普正处于充血性心力衰竭的III期试验，预计2002年提交补充新药申请（sNDA）；然而，到2001年3月，这些试验已停止，因为似乎无法达到疗效终点的统计学显著性。此时正在进行进一步的数据分析，然后再做出最终决定。2001年4月，美林公司报告称该适应症的研发将停止。该药物在1999年上市后的首个完整季度销售额为5970万美元。到1999年11月，该药物销售额已达5亿美元；免疫ex公司预计到2004年该药物年销售额将超过20亿美元。2000年9月，美林公司报告称，如果该药物的销售继续保持目前的速度，那么2001年需求可能会暂时超过供应。预计到200
