Orencia SC 125 mg Syringe 1mL Launched in Japan
Rheumatoid Arthritis Drug ORENCIA® SC 125mg Syringe 1mL Launched in Japan
OSAKA, Japan, August 27, 2013- Ono Pharmaceutical Co., Ltd. (Head Office: Osaka City; President and Representative Director: GyoSagara; “Ono”) and Bristol-Myers K.K. (Head Office: Shinjuku-ku, Tokyo; President & CEO:Emmanuel Blin; “BMKK”) are delighted to announce that the two companies today launched the rheumatoid arthritis drug ORENCIA® Subcutaneous Injection 125mg Syringe 1mL (generic name:abatacept (genetic recombination), “ORENCIA ® SC”).
ORENCIA ® SC suppresses the release of cytokines by inhibiting the signals that activate T-cells, resulting in the suppression of joint inflammation. As of August 2013, the product has been approved in a total of over 40 countries, including the United States and the countries of the European Union.In Japan, the product was approved by the Ministry of Health, Labour and Welfare to bemanufactured and marketed with an indication for the treatment of rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) on June 28, 2013.
The new product uses a prefilled syringe with an attached needle cover, which can be expected toreduce the risk of infections from needle use and improve safety for both healthcare professionals and rheumatoid arthritis patients. Where physicians deem it appropriate, the product can be used bypatients for self-injection. Along with the preparation for intravenous infusion which is already on the market, the addition of a new formulation for subcutaneous injection allows patients to receivetreatment that matches their own lifestyle, making an even greater contribution to the treatment of patients worried by rheumatoid arthritis.
Information on the appropriate use of ORENCIA® is available on the website www.orencia.jp, whichis intended for healthcare professionals.
About rheumatoid arthritis (RA) Rheumatoid arthritis is a chronic autoimmune disease characterized by inflammation of jointsynovium. Major symptoms are pain and swelling of joints in hands and legs/feet. When inflammation of joint synovium progresses or is prolonged, joints being to destruct, causing advanced functional disability that interfere with daily routines and reduces quality of life (QOL). For further information o nRA, please visit the Rheumatism Tea Room at http://www.bms.co.jp/ra/index.html.
Overview of ORENCIA® SC 125mg Syringe 1mLProduct name ORENCIA® SC 125mg Syringe 1mLGeneral name Abatacept (Genetic recombination)Approval date forproduction/distributionJune 28, 2013NHI price listing August 27, 2013Product launch August 27, 2013NHI price 27,171 yenManufacturer /Distributor(Importer)Bristol-Myers K.K.Distributor Ono Pharmaceutical Co., Ltd.Indication or usage Rheumatoid arthritis (only for patients with an inadequate response to priorconventional therapy)Dosage andAdministrationFollowing an intravenous loading dose with the ORENCIA® IV, 125mgsubcutaneous injection of ORENCIA® SC should be given within the firstadministration day, followed by 125mg subcutaneous injections once weekly foradult patients. Weekly 125mg subcutaneous injections of ORENCIA® SC mayalso be initiated.
Collaboration between Ono and BMKKOno and BMKK concluded an agreement to jointly promote ORENCIA® in September 21, 2011, and,commenced co-promotion of ORENCIA®IV on June 4, 2013. The two companies have also beenco-developing ORENCIA®. With ORENCIA® IV and ORENCIA® SC, we will further contribute to thetreatment of rheumatoid arthritis.
About Ono Pharmaceutical Co., Ltd.Ono Pharmaceutical Co., Ltd. is a R&D-oriented pharmaceutical company specialized in creatinginnovative medicines in specific areas and is headquartered in Osaka, Japan. For more informationabout Ono, visit the company’s website at www.ono.co.jp./eng/index.html.
About Bristol-Myers K.K.Bristol-Myers K.K. is the Japanese subsidiary of Bristol-Myers Squibb, a global biopharmaceuticalcompany whose mission is to discover, develop and deliver innovative medicines that help patientsprevail over serious diseases. For further information, visit the company’s website athttp://www.bms.co.jp.
Contacts:Ono Pharmaceutical Co., Ltd. Bristol-Myers K.K.Corporate Communications+81-6-6263-5670Public Affairs & Communications+81-3-6705-7787Yukio Tani, email@example.com Hisashi Takanashi, firstname.lastname@example.org
Ono Pharmaceutical Co., Ltd. Bristol-Myers K.K.
Corporate Communications Public Affairs & Communications
Phone: +81-6-6263-5670 Phone: +81-3-6705-7787
Posted: August 2013