Bindra Sanjit, Cefalu William T
University of Vermont College of Medicine, Department of Medicine, Burlington 05405, USA.
Curr Opin Investig Drugs. 2002 May;3(5):758-62.
Inhale, in colaboration with Pfizer and Aventis Pharma (formerly Hoechst Marion Roussel; HMR), is developing an insulin formulation utilizing its pulmonary delivery technology for macromolecules for the potential treatment of type I and II diabetes. By July 2001, the phase III program had been completed and the companies had begun to assemble data for MAA and NDA filings; however, it was already clear at this time that additional data might be required for filing. By December 2001, it had been decided that the NDA should include an increased level of controlled, long-term pulmonary safety data in diabetic patients and a major study was planned to be completed in 2002, with the NDA filed thereafter (during 2002). US-05997848 was issued to Inhale Therapeutic Systems in December 1999, and corresponds to WO-09524183, filed in February 1995. Equivalent applications have appeared to date in Australia, Brazil, Canada, China, Czech Republic, Europe, Finland, Hungary, Japan, Norway, New Zealand, Poland and South Africa. This family of applications is specific to pulmonary delivery of insulin. In February 1999, Lehman Brothers gave this inhaled insulin a 60% probability of reaching market, with a possible launch date of 2001. The analysts estimated peak sales at $3 billion in 2011. In May 2000, Aventis predicted that estimated peak sales would be in excess of $1 billion. In February 2000, Merrill Lynch expected product launch in 2002 and predicted that it would be a multibillion-dollar product. Analysts Merril Lynch predicted, in September and November 2000, that the product would be launched by 2002, with sales in that year of e75 million, rising to euro 500 million in 2004. In April 2001, Merrill Lynch predicted that filing for this drug would occur in 2001. Following the report of the potential delay in regulatory filing, issued in July 2001, Deutsche Banc Alex Brown predicted a filing would take place in the fourth quarter of 2002 and launch would take place in the first quarter of 2003. In August 2001, Lehman Brothers predicted that launch would take place in the first half of 2002 and that the product would make sales of $475 million in 2003, rising to $875 million in 2004. In the same month, Deutsche Bank predicted that there would be worldwide sales of $50 million in 2003, rising to $400 million in 2005. At this time, analysts at Credit Suisse predicted a launch of the product in 2003, with sales of $70 million in that year, rising to $550 million in 2005. By October 2001, Deutsche Bank predicted sales of $50 million in 2004 and $250 million in 2005. In September 2001, Morgan Stanley predicted sales of $500 million in 2002, rising to $1250 million in 2006.
英赛力公司（Inhale）与辉瑞公司及安万特制药公司（原赫斯特-马里恩-卢梭公司；HMR）合作，正在利用其针对大分子的肺部给药技术开发一种胰岛素制剂，用于潜在治疗I型和II型糖尿病。到2001年7月，III期项目已经完成，两家公司已开始收集用于向药品管理局（MAA）和新药申请（NDA）备案的数据；然而，此时已经清楚可能需要更多数据才能备案。到2001年12月，已决定新药申请应包括糖尿病患者中更高水平的受控长期肺部安全性数据，并计划在2002年完成一项主要研究，之后（在2002年期间）提交新药申请。美国专利号05997848于1999年12月授予英赛力治疗系统公司，对应于1995年2月提交的WO-09524183。迄今为止，在澳大利亚、巴西、加拿大、中国、捷克共和国、欧洲、芬兰、匈牙利、日本、挪威、新西兰、波兰和南非都出现了等效申请。这一系列申请专门针对胰岛素的肺部给药。1999年2月，雷曼兄弟公司认为这种吸入式胰岛素进入市场的概率为60%，可能的推出日期为2001年。分析师估计2011年的峰值销售额为30亿美元。2000年5月，安万特公司预测估计的峰值销售额将超过10亿美元。2000年2月，美林公司预计该产品将在2002年推出，并预测它将成为一个数十亿美元的产品。美林公司的分析师在2000年9月和11月预测，该产品将在2002年推出，当年销售额为7500万欧元，到2004年升至5亿欧元。2001年4月，美林公司预测该药物将在2001年提交申请。在2001年7月发布关于监管备案可能延迟的报告后，德意志银行亚历克斯·布朗公司预测将在2002年第四季度提交申请，并于2003年第一季度推出。2001年8月，雷曼兄弟公司预测将在2002年上半年推出，该产品2003年的销售额将达到4.75亿美元，到2004年升至8.75亿美元。同月，德意志银行预测2003年全球销售额将为5000万美元，到2005年升至4亿美元。此时，瑞士信贷的分析师预测该产品将在2003年推出，当年销售额为7000万美元，到2005年升至5.5亿美元。到2001年10月，德意志银行预测2004年销售额为5000万美元，2005年为2.5亿美元。2001年9月，摩根士丹利预测2002年销售额为5亿美元，到2006年升至12.5亿美元。
