Chugai Pharmaceutical Announces Positive Interim Data from Phase I/II Hemophilia A Study
Jul 3 15
Chugai Pharmaceutical Co. Ltd. has announced positive interim data from ACE002JP, a Phase I/II study of ACE910 in Japanese patients with hemophilia A. ACE002JP is the extension study of ACE001JP study, which is the first-in-patient Phase I study to investigate safety and exploratory prophylactic efficacy profiles of anti-factor IXa x anti-factor X humanized bispecific antibody "ACE910," in Japanese hemophilia A patients both with and without FVIII inhibitors. Interim data of these studies showed a promising profile in terms of safety and prophylactic efficacy irrespective of the presence of inhibitors during 5.6 to 18.5 months (follow up periods). Adverse events (AEs) were observed in 18 patients and all of them were mild or moderate in terms of intensity. Of these, side effects which cannot be ruled out as having a causal relationship with ACE910 were observed in six patients and the common symptom was injection site erythema. There was no evidence of clinically relevant abnormalities of coagulation indicated by clinical findings or laboratory tests in all cohorts. No thromboembolic AEs were observed, even when ACE910 was given concomitantly with FVIII products or bypassing agents as on-demand therapy for bleeding events. Three patients developed anti-ACE910 antibodies screened by electro-chemiluminescence immunoassay (ECLIA), which did not affect the Pharmacokinetics (PK) or Pharmacodinamics (PD) of ACE910. Once-weekly subcutaneous injection of ACE910 demonstrated a prophylactic efficacy profile in all cohorts irrespective of the presence of inhibitors. Bleeding was completely controlled in 9 out of 18 patients during the course of ACE910 administration.
Chugai Pharmaceutical Co., Ltd. Announces Integration and Reorganization of Overseas Subsidiaries
Jun 26 15
Chugai Pharmaceutical Co. Ltd. announced that it will integrate and reorganize its subsidiaries in Europe, China and Taiwan in order to further accelerate its overseas business activities. This integration and reorganization have two major purposes. On April 1, 2015, Chugai established the Translational Clinical Research (TCR) Division in order to rapidly acquire early Proof-of-Concept (PoC) for drugs under development that had been discovered and created in-house. The first purpose is to straighten the internal structure as the TCR Division will be in full operation. In addition, until now, the company had separated its activities such as clinical development, import, and sales into respective subsidiary companies depending on the function in each country. By integrating these functions into one company, Chugai will streamline the operations from development to sales and marketing. This will enhance its specialty of each function as well as the competence to collaborate and work together to increase customer satisfaction. The second purpose is to develop Chugai's unique business to provide high value-added services by further strengthening the foundation of its business through this integration and reorganization. Details of this integration and reorganization in Europe, China and Taiwan are: [Europe] he business function of Chugai Pharma Europe Ltd. will be transferred to Chugai Pharma Marketing Ltd. and the two companies will be integrated as of July 1, 2015. hugai Pharma Europe Ltd. will initiate the liquidation proceedings in due course after completion of transferring procedure. verview of the Post-reorganized company. Company name: Chugai Pharma Marketing Ltd. Location: Mulliner House, Flanders Road, Turnham Green, London W4 1NN, U.K. Capital: 8,677,808 GBP (100% Owned by Chugai). Activities: Clinical development, regulatory affairs, medical affairs, import, sales and marketing of pharmaceutical products in Europe. Representative: John Halls (Managing Director of current Chugai Pharma Marketing Ltd.). Number of Employees: 49 [China] he business function of Chugai Pharma (Shanghai) Consulting Co. Ltd. will be transferred to Chugai Pharma China Co. Ltd. hugai Pharma (Shanghai) Consulting Co. Ltd. will initiate the liquidation proceedings in due course after completion of transferring procedure. verview of the Post-reorganized Company. Company name: Chugai Pharma (China) Co. Ltd. Location: Building G31, No. 801 Jiankang Dadao, Medical City Taizhou, Jiangsu 225300 . Capital: 30 million USD (100% Owned by Chugai). Activities: Import and sales of the pharmaceutical products in China. Representative: Takashi Sakabe (Representative of current Chugai Pharma China Co. Ltd.). Number of Employees: 54 [Taiwan] hugai Pharma R&D Taiwan Ltd., a subsidiary which conducts clinical development and related business activities of products contracted by Chugai or Chugai Pharma Taiwan Ltd., will integrate with Chugai Pharma Taiwan Ltd. hugai Pharma R&D Taiwan Ltd. will initiate the liquidation proceedings in due course after completion of transferring procedure. verview of the Post-reorganized Company. Company name: Chugai Pharma Taiwan Ltd. Location: 3Fl., No. 73, ZhouZi Street, Neihu District, Taipei 11493 Taiwan. Capital: 33,376,000 TWD (100% Owned by Chugai). Activities: Clinical development, regulatory affairs, import, sales and marketing of the pharmaceutical products in Taiwan. Representative: Tatsuji Shimada (Representative of current Chugai Pharma Taiwan Ltd. and Department manager of Overseas Business Dept.). Number of Employees: 63 Under its business philosophy 'Innovation all for the patients,' Chugai is committed to creating new value through offering innovative medical products and services, thereby contributing to healthcare and human health around the world.
Chugai Pharmaceutical Co. Ltd. Presents at BIO International Convention 2015, Jun-16-2015 11:00 AM
Jun 11 15
Chugai Pharmaceutical Co. Ltd. Presents at BIO International Convention 2015, Jun-16-2015 11:00 AM. Venue: Pennsylvania Convention Center, Philadelphia, Pennsylvania, United States.