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Toray and Astellas Pharma Announce of the Acquisition of Marketing Approval for the Pulmonary Arterial Hypertension Agent Careload(R) LA Tablets 60mu/g in Japan.


Tokyo, Japan, Oct 22, 2007 - (JCN JCN Japan Corporate News
JCN Journal of Cognitive Neuroscience
JCN Journal of Cardiovascular Nursing
JCN Journal of Christian Nursing
JCN Job Control Number
JCN Journal of Child Neurology
JCN joint communications network (US DoD) 
 Newswire) - Toray Industries Inc. (TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
: 3402) and Astellas Pharma Inc. (TSE: 4503) today announced that Toray has obtained marketing approval for its oral PGI PGI Protected Geographical Indication
PGI Progiciel de Gestion Intégré (French: Enterprise Resource Planning)
PGI Phosphoglucose Isomerase
PGI Polish Geological Institute (Warsaw, Poland) 
2 derivative prolonged release, Careload(R) LA Tablets 60mu/g (generic name generic name
n.
1. The official nonproprietary name of a drug, under which it is licensed and identified by the manufacturer.

2.
: beraprost sodium), to be indicated for pulmonary arterial hypertension (PAH PAH, PAHA aminohippuric acid.

PAH
abbr.
para-aminohippuric acid


PAH 1 Polycyclic aromatic hydrocarbon, see there 2. Pulmonary artery HTN
) on October 19,2007. Careload will be listed in the NHI NHI
abbr.
National Health Insurance
 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 Pulmonary Hypertension Definition

Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right
 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.

About PAH

PAH is that peripheral arteriole arteriole /ar·te·ri·ole/ (ahr-ter´e-ol) a minute arterial branch.arterio´lar

afferent glomerular arteriole  a branch of an interlobular artery that goes to a renal glomerulus.
 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 dyspnea /dysp·nea/ (disp-ne´ah) labored or difficult breathing.dyspne´ic

paroxysmal nocturnal dyspnea
, fatigability fatigability /fat·i·ga·bil·i·ty/ (fat?i-gah-bil´it-e) easy susceptibility to fatigue.

fatigability

easy susceptibility to fatigue.
 and palpitation palpitation (păl'pĭtā`shən), abnormal heartbeat that is often associated with a sensation of fluttering or thumping. The normal heartbeat is not noticeable to the individual.  are commonly observed initial symptoms, and once it advances, heart failure may result.

About Careload(R)

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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. : 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.

See http://www.astellas.com/global/about/news/2007/pdf/071022_eg.pdf

About Toray Industries, Inc.

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.

Source: Toray Industries, Inc.Astellas Pharma Inc.

Contact:
Toray Industries Inc.
Corporate Communications
Tel: +81-3-3245-5179

Astellas Pharma Inc.
Corporate Communications
Tel: +81-3-3244-3201


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Publication:JCN Newswires
Date:Oct 23, 2007
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