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March 7, 2014
05:37 EDTINCYIncyte announces Phase III study of ruxolitinib meets primary endpoint
Incyte announced that a pivotal Phase III trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea has met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35% or more. The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data. Ruxolitinib, marketed as Jakafi in the United States, is approved to treat people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. The global, randomized, open-label Phase III trial, called RESPONSE, was conducted at 109 sites. The trial included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib or best available therapy. The dose was adjusted as needed throughout the trial. The primary endpoint of the trial is the proportion of patients whose hematocrit level is controlled in absence of phlebotomy and whose spleen volume is reduced by 35 percent or more from baseline as assessed by imaging at 32 weeks. In addition to safety, key secondary endpoints include durable response and complete hematological remission. Data from RESPONSE are expected to be presented at an upcoming scientific meeting and submitted to the FDA this year.
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September 2, 2015
05:36 EDTINCYIncyte announces global license agreement with Jiangsu Henrui Medicine
Incyte announced a global license and collaboration agreement with Jiangsu Hengrui Medicine for the development and commercialization of SHR-1210, an investigational anti-PD-1 monoclonal antibody. Under the agreement, Incyte will have the exclusive development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan. SHR-1210 is expected to enter proof-of-concept studies for the treatment of patients with advanced solid tumors in the coming months. Under the terms of the agreement, Incyte will acquire development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan, in exchange for an upfront payment of $25M. The terms also include potential milestone payments of up to $770 million to Hengrui, consisting of $90M for regulatory approval milestones, $530M for commercial performance milestones, and $150M based on clinical superiority. The terms also include tiered royalties to Hengrui on net sales of SHR-1210 in Incyte territories. Under the Agreement, Incyte and Hengrui will assume all financial obligations associated with the development and commercialization of SHR-1210 in their respective territories.
August 23, 2015
12:35 EDTINCYBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
08:55 EDTINCYIncyte management to meet with JPMorgan
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