Pegasys (Hoffmann-La Roche).
Pegasys (Hoffmann-La Roche).
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派罗欣（霍夫曼-拉罗氏）。
DOI：
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发表时间：
2001
影响因子：
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通讯作者：
D. Barnard
中科院分区：
文献类型：
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作者：
D. Barnard
Hoffmann-La Roche开发了一种聚乙二醇化干扰素α-2a，Pegasys，用于慢性丙型肝炎和B型肝炎病毒感染的潜在治疗。2001年8月首次在瑞士获批[418260]，预计将于2001年9月/10月上市[419333]。2000年5月，Roche向美国FDA提交了BLA，以批准Pegasys上市，用于治疗代偿性肝病非肝硬化和肝硬化患者的慢性HCV感染[329872]，[348368]，[367781]。2000年12月仍有待批准[387363]，[392481]。罗氏公司预计在2001年下半年在美国上市[400857]。2001年4月，Roche收到了FDA关于Pegasys的完整回复函，并与FDA合作解决信函[407595]，[418310]中提出的问题。2001年8月，Roche预计HCV将于2002年在美国获批，HBV将于2004年获批[419333]。此时，罗氏计划提交与利巴韦林联合用药的sNDA [421285]。到2001年3月，欧盟和加拿大已经提交了申请[401793]。罗氏还计划分别于2004年和2005年推出用于慢性HBV感染和各种恶性肿瘤的产品[400857]。Pegasys于2000年上半年在巴西申请注册[418310]。截至1999年12月，该药在日本处于HCV感染的II期。它由Nippon Roche开发，旨在推断国外III期数据，用于日本的NDA申请[351804]。作为2001年3月日本PMSB会议的结果，如果提交，Pegasys可能在其NDA审查中获得优先权[403782]。2001年8月，先灵葆雅与F Hoffman-La Roche Ltd和Hoffmann-La Roche Inc达成了一项许可协议，解决了两家公司关于PEG干扰素产品的所有专利纠纷。根据协议条款，先灵葆雅和罗氏将交叉许可对方适用于Peg-Intron和Pegasys的所有专利。和解协议还包括先灵葆雅将Enzon的分支PEG专利分许可给罗氏[418935]，[418956]。Roche正在与Maxim Pharmceuticals合作开发PEG-IFN α-2a，并与Maxim的Maxamine联合使用[378609]。1998年7月，Hoffmann-La Roche和韦斯顿Medical签署了一项全球协议，许可INTRAPINE（韦斯顿的一次性、预充式、无针注射器，用于皮下注射注射液体药物）用于输送Pegasys [292119]。1999年4月，荷兰银行预测2000年的年销售额为2500万瑞士法郎，2002年将增至7500万瑞士法郎[328676]。2000年9月，梅里尔预测2001年的销售额为7000万瑞士法郎，2004年将增至7亿瑞士法郎[383742]。2001年3月，德意志银行估计该产品的销售潜力为16亿瑞士法郎[421009]。
Hoffmann-La Roche has developed a PEGylated interferon alpha-2a, Pegasys, for the potential treatment of chronic hepatitis C and hepatitis B virus infection. It was first approved in Switzerland in August 2001 [418260] and was expected to be launched in September/October 2001 [419333]. In May 2000, Roche submitted a BLA to the US FDA, for approval to market Pegasys for the treatment of chronic HCV infection in non-cirrhotic and cirrhotic patients with compensated liver disease [329872], [348368], [367781]. Approval was still pending in December 2000 [387363], [392481]. Roche expects the US launch to take place in the second half of 2001 [400857]. In April 2001, Roche received a complete response letter from the FDA for Pegasys and was working with the FDA to address the questions raised in the letter [407595], [418310]. In August 2001, Roche expected approval for HCV in the US in 2002 and for HBV in 2004 [419333]. At this time, Roche planned to file an sNDA for combination with ribavirin [421285]. By March 2001, EU and Canadian filings had been made [401793]. Roche also planned to launch the product for chronic HBV infection and various malignancies in 2004 and 2005, respectively [400857]. Pegasys was filed for registration in Brazil in the first part of 2000 [418310]. As of December 1999, the drug was in phase II for HCV infection in Japan. It is being developed by Nippon Roche, which intended to extrapolate foreign phase III data for use in an NDA application in Japan [351804]. As a result of a meeting of Japan's PMSB in March 2001, Pegasys may be given priority in the review of its NDA, if submitted [403782]. In August 2001, Schering-Plough entered into a licensing agreement with F Hoffman-La Roche Ltd and Hoffmann-La Roche Inc that settles all patent disputes regarding the two companies' PEGinterferon products. Under the terms of the agreement, Schering-Plough and Roche will cross license to each other all patents applicable to Peg-Intron and Pegasys. The settlement agreement also includes a Schering-Plough sublicense of Enzon's branched PEG patents to Roche [418935], [418956]. Roche is collaborating with Maxim Pharmceuticals to develop PEG-IFN alpha-2a in conjunction with Maxim's Maxamine [378609]. In July 1998, Hoffmann-La Roche and Weston Medical signed a global agreement to license INTRAJECT (Weston's single-use, disposable, prefilled, needle-free injector for subcutaneous delivery of injectable liquid pharmaceuticals) for delivery of Pegasys [292119]. In April 1999, ABN Amro predicted annual sales of SFr 25 million in 2000, rising to SFr 75 million in 2002 [328676]. In September 2000, Merrill Lynch predicted sales of SFr 70 million in 2001, rising to SFr 700 million in 2004 [383742]. In March 2001, Deutsche Bank estimated that the product has sales potential of SFr 1600 million [421009].