[{"orgOrder":0,"company":"Kowa Pharmaceuticals America","sponsor":"Esteve Huayi Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Esteve and Kowa Pharmaceuticals America Enter into an Exclusive License and Commercialization Agreement for Rights to E-58425","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Kowa Pharmaceuticals America","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kowa To Discontinue K-877 (Pemafibrate) \"Prominent\" Cardiovascular Outcomes Study","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Kowa Pharmaceuticals America","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kowa Pharmaceuticals America,Inc. Announces Publication of Phase 3 Data Supporting FDA Approval of SEGLENTIS\u00ae(celecoxib 56-mg and tramadol hydrochloride 44mg)CI-V as an Efficacious Alternative for Moderate-to-Severe Acute Pain in Appropriate Patients","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Kowa Pharmaceuticals America","sponsor":"Nicox SA","pharmaFlowCategory":"D","amount":"$32.8 million","upfrontCash":"$3.2 million","newsHeadline":"Nicox and Kowa Enter into Agreement for NCX 470 Development and Commercialization in Japan","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Kowa Pharmaceuticals America
The agreement granting Kowa to focus on the development and commercialization of NCX470 (bimatoprost), Nicox’s nitric oxide, which is used for the lowering of intraocular pressure in patients with glaucoma or ocular hypertension.
The primary efficacy endpoint met and studied was summed pain intensity difference from 0 to 48 hours (SPID0-48). SEGLENTIS (celecoxib) had a significantly greater effect on SPID0-48 (least-squares mean: −139.1 than tramadol, celecoxib or placebo.
K-877 (pemafibrate), a highly potent and selective peroxisome proliferator activator receptor-alpha modulator for treatment of hyperlipidemia in Japan under brand name PARMODIA, will discontinue by DSMB who concluded that primary endpoint was unlikely to be met.
Under the terms of the agreements, ESTEVE has granted KPA exclusive rights to commercialize E-58425 in the United States. E-58425 is a new product comprised of a co-crystal form of celecoxib and tramadol for the management of acute pain in adults.