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Announcement of the Acquisition of Marketing Approval for the Pulmonary Arterial Hypertension Agent Careload® LA Tablets 60μg in Japan -- The World First Oral Prostacyclin (PGI2) Derivative Prolonged Release -- |
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Japan October 22, 2007 - Toray Industries Inc. (“Toray”; Headquarters: Tokyo, President and CEO: Sadayuki Sakakibara) and Astellas Pharma Inc. (“Astellas”; Headquarters: Tokyo; President and CEO: Masafumi Nogimori) today announced that Toray has obtained marketing approval for its oral PGI2 derivative prolonged release, Careload® LA Tablets 60μg (generic name: beraprost sodium), to be indicated for pulmonary arterial hypertension (PAH) on October 19,2007. Careload will be listed in the NHI drug price list and launched in December 2007. Beraprost sodium is a PGI2 derivative discovered by Toray. Toray has been developing many formulations of beraprost sodium for a long period and achieved to sustain its blood concentration and lower the maximum blood concentration (Cmax) of it. Toray has submitted an application for beraprost sodium with indication for PAH based on the results of Japanese clinical trials subjecting primary pulmonary hypertension and pulmonary hypertension following collagenosis in September 2006. It has been designated for a priority review by Ministry of Health, Labour and Welfare in February 2007. Careload® LA Tablets 60μg has been admitted its efficacy and safety and obtained marketing approval for treatment of PAH. About PAH PAH is that peripheral arteriole lumen of pulmonary artery where blood pumped from heart to lung gets narrow, and it makes difficult for blood to flow. This causes pulmonary artery high pressure. PAH is classified in two types, one is primary pulmonary hypertension (PPH), and the other is secondary pulmonary hypertension following specific diseases. Exertional dyspnea, fatigability and palpitation are commonly observed initial symptoms, and once it advances, heart failure may result. About Careload® Careload® is the world first oral PGI2 derivative prolonged release and expected to provide a new therapeutic choice, an oral agent which can be widely used, to patients suffering from PAH. Toray had obtained marketing approval for beraprost sodium tablets to be indicated for improvement of ulcer, pain and feeling of coldness associated with chronic arterial occlusion in January 1992, primary pulmonary hypertension in September 1999, and it has already been available in Japanese market as Dorner® Tablets by Astellas since April 1992. Careload® LA Tablets 60μg will be marketed by Astellas as well as Dorner® tablets. Kaken Pharmaceutical Co., Ltd (Headquarters: Tokyo, President and CEO: Shiro Inui) has submitted the identical compound, beraprost sodium prolonged release, and also obtained marketing approval with a brand name, BERASUS® LA Tab. 60μg, on October 19, 2007. Details of approval are as follows:
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