TOKYO, February 26, 2010_Ube Industries, Ltd. today announced that it is strengthening its pharmaceutical business by launching a new Pharmaceutical Division, effective April 1, 2010. The new organization will report directly to the President, and positions the pharmaceutical business as the third cornerstone of Ube's chemicals business, in addition to the Chemicals & Plastics Company and Specialty Chemicals & Products Company. The move signifies the transformation of Ube's pharmaceuticals business from a developing business into a strategic growth businesses, as targeted under the company's current Stage Up 2009 mid-term management plan.
With a view toward strengthening the pharmaceutical business and enhancing risk management, Ube will move the API & Intermediates Business Unit (currently under the Specialty Chemicals & Products Company) and the Pharmaceuticals Development Department (currently under Corporate Research & Development) to the new Pharmaceutical Division, to be renamed as the API & Intermediates Marketing & Development Dept. and the Project Development & Management Dept. respectively. Ube has chosen Executive Officer Nobuyuki Taenaka to head the new organization.
The pharmaceutical business of Ube Industries has brought to market three major drugs through proprietary new drug discovery and collaborative R&D with pharmaceutical companies. The first of these were the Talion® antiallergic agent and Calblock® antihypertensive agent. Most recently, antiplatelet agent, prasugrel (marketed under the trade name Effient™ ) was approved for marketing in Europe and the US in February and July 2009 respectively, and is currently enjoying growing sales in those regions.
The establishment of the Pharmaceutical Division will enable Ube to pursue the commercialization of successor proprietary drugs with greater efficiency, while also strengthening the level of collaboration with major drug companies and accelerating the pace of drug development.
The pharmaceuticals business of Ube Industries also manufactures APIs and intermediates for new drugs as a custom manufacturing for pharmaceutical companies in Japan and oversea, as well as manufacturing APIs for Ube's proprietary APIs. The custom manufacturing business draws on Ube's extensive experience in the development of industrialized processes and manufacturing of fine chemicals.
Prompted by the current growth of the custom manufacturing business, Ube is presently building a fourth API manufacturing facility that will be compliant with current Good Manufacturing Practice (cGMP), to be ready by July 2011. Ube will move forward by pursuing strategies intended to further accelerate growth for the manufacturing and supply of APIs both for proprietary drugs and as a custom manufacturing, as well as pursuing the proprietary drug business.
Ube will also create a new Pharma Quality Assurance Department as a separate department to effectively audit organizations connected with the pharmaceutical business. The move will enable Ube to establish a suitable framework for securing stringent compliance with the Pharmaceutical Affairs Law and other government regulations, and achieving quality assurance in products, data and information for users and supervisory agencies.
Talion® is a registered trademark of Mitsubishi Tanabe Pharma Corporation.
Calblock® is a registered trademark of Daiichi Sankyo Co., Ltd.
Effient™ is a trade mark of Eli Lilly and Company.