SUCAMPO PHARM 'A' : R-Tech Ueno's Sanda Factory Gets U.S. Nod for Manufacture of Rescula(R) Eye Drops
05/06/2010| 06:55am US/Eastern
TOKYO, May 6 /PRNewswire/ -- The Sanda factory of R-Tech Ueno, Ltd. has received notice from the U.S. Food and Drug Administration (FDA) that its facility has been classified as acceptable for the production of pharmaceuticals by meeting compliance with U.S. cGMP regulations (see the note below). The FDA inspected the Sanda factory in December 2009. By passing this inspection, Resculaź Eye Drops (unoprostone isopropyl eye drops) manufactured at this factory may be exported for sale in the United States.
R-Tech Ueno announced the signing of a contract with Sucampo Pharmaceuticals, Inc. (Nasdaq code: SCMP) for the sale of Resculaź Eye Drops in the United States and Canada in a press release dated April 24, 2009. Under this agreement, Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, is granted the right to sell Resculaź Eye Drops in the United States and Canada for the treatment of glaucoma and ocular hypertension and is licensed to use Rescula's patent protection to develop new uses. R-Tech Ueno has the exclusive right to supply the eye drops to Sucampo Pharma Americas.
Passing this inspection will not affect the performance of R-Tech Ueno at this time. However, it allows the company to manufacture and export this pharmaceutical to the United States, which is one of the world's largest markets for pharmaceuticals. R-Tech Ueno believes that successfully passing this inspection will lead directly to future growth in R-Tech Ueno's contract manufacturing services.
"We will aggressively pursue opportunities to manufacture pharmaceuticals and investigational drugs for customers in the United States. We also plan to offer R&D support services for U.S. pharmaceutical companies," stated R-Tech Ueno President Yukihiko Mashima. "In addition, we can provide customers in Japan with high-quality services such as OEM production and technical assistance for their research programs. I believe these capabilities will allow us to capture more outsourcing contracts and broaden the scope of our business operations."
cGMP is an abbreviation for current good manufacturing practices. Good manufacturing practices are a system of management and other items concerning manufacturing that originated in the United States for the purpose of supplying quality drugs and medical devices. In Japan, good manufacturing practices are prescribed in a Ministry of Health, Labor and Welfare ordinance titled "Standards for Manufacturing Management and Quality Management for Drugs, Quasi-drugs, Etc." The manufacturing activities of all pharmaceutical companies must comply with these standards.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. Sucampo markets Amitizaź (lubiprostone) 24 mcg in the U.S. for chronic idiopathic constipation in adults and Amitiza 8 mcg in the U.S. to treat irritable bowel syndrome with constipation in adult women. Sucampo also is developing Amitiza for additional gastrointestinal disorders with large potential markets. In addition, Sucampo has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has three wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., located in the UK; Sucampo Pharma, Ltd., located in Japan; and Sucampo Pharma Americas, Inc., located in Maryland. To learn more about Sucampo Pharmaceuticals and its products, visit www.sucampo.com.
Amitizaź is a registered trademark of Sucampo Pharmaceuticals.
About R-Tech Ueno, Ltd.
R-Tech Ueno is a bio venture company established in September 1989 for the purpose of marketing and R&D of drugs. Under the leadership of the CEO, also a medical doctor, the company is developing new drugs on the theme "Physician-Oriented New Drug Innovation," targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent. We aim at becoming a "global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) and selling and developing pharmaceutical products through the eyes of doctors." We are promoting development of new drugs of unmet medical needs (medical needs that are not fulfilled yet) which the government recommends and assists, orphan drugs and the drugs in the field of anti-aging medicine (lifestyle drugs).
Stock Code: No.4573, Osaka Securities Exchange; Hercules
Head Office: 1-1-7 Uchisaiwai-cho, Chiyoda-ku, Tokyo
Representative Director & President: Yukihiko Mashima
Business Management Department
R-Tech Ueno, Ltd.
SOURCE R-Tech Ueno, Ltd.