Tokyo, Oct 22, 2007 (JCN Newswire) - Toray Industries Inc. (TSE: 3402) and Astellas Pharma Inc. (TSE: 4503) today announced that Toray has obtained marketing approval for its oral PGI2 derivative prolonged release, Careload(R) LA Tablets 60mu/g (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 60mu/g has been admitted its efficacy and safety and obtained marketing approval for treatment of 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.
Careload(R) 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(R) Tablets by Astellas since April 1992. Careload LA Tablets 60 mu/g 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(R) LA Tab. 60mu/g, on October 19, 2007.
Toray, a leading diversified chemicals corporate group, has been technology-focused since its foundation in 1926. The company's operations are underpinned by technological expertise in organic synthetic chemistry, polymer chemistry, and biochemistry - Toray's three core technologies. These innovative technologies have yielded "advanced materials" that Toray is now exploiting to provide customers with comprehensive solutions through Fibers and Textiles, Plastics and Chemicals, IT-related Products, Housing and Engineering, Pharmaceuticals and Medical Products, New Products and Other Business divisions. In FY2006, Toray had consolidated sales of 1,547 billion yen, and over 34,670 employees worldwide.
About Astellas Pharma Inc.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's website at www.astellas.com.
Toray Industries Inc.
Astellas Pharma Inc.
Oct 22, 2007
Source: Astellas Pharma Inc.
Toray (TSE: 3402) (U.S: TRYIY)
Astellas Pharma Inc. (TSE: 4503) (U.S: ALPMF)
From the Japan Corporate News Network
Topic: Press release summary
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