中外製薬 バイオ抗体原薬生産プラント新設へ 6000L級６基 複数開発備え 投資額372億円 公開日時 2015/10/23 03:52 中外製薬は10月22日、東京の浮間工場内にバイオ抗体原薬生産プラントを新設することを決定したと発表した。自社開発品の後期開発用治験薬、初期商業用のバイオ抗体原薬の生産用で、今後がんなどのバイオ新薬の開発品が継続的に創出されることに備えるもの。6000L級の培養槽を６基新設し、複数品目の同時開発に対応できるようにすることで、開発から上市までのスピードアップを図る。2016年１月に着工し、18年７月に竣工、19年６月の稼働を目指す。総投資額は372億円。新プラントの生産の対象になる開発品は非開示。浮間工場には培養槽が2500L級が２基、2000L級が４基あり、今回の新設分を合わせると計４万9000Lを保有することになる。浮間には製法開発の研究拠点を備えており、製法開発から初期商業用バイオ抗体原薬生産の一貫体制が整うとしている。なお、宇都宮工場にはバイオ抗体原薬生産のための１万L級の培養槽が８基ある。
Chugai to construct new antibody API manufacturing plant 23-10-2015 Chugai has been continuously conducting new drug development aiming for the world's highest level of quality and speed under the strategic alliance with Swiss pharma giant Roche (ROG: SIX), which owns around 60% of the company. In 2012, it established a research laboratory in Singapore, Chugai Pharmabody Research (CPR), focusing on drug discovery research applying its proprietary antibody engineering technologies. Furthermore, Chugai has adopted various measures to maximize the value of drug candidates arising from its research, such as the amendments to the out-licensing agreement of Chugai products to Roche and the establishment of the Translational Clinical Research Division.
$313 million investment The total amount for this capital investment is 37.2 billion yen ($312.6 million). With this capital investment, six 6,000 L bioreactor tanks will be newly installed. Combined with the existing two 2,500 L tanks and four 2,000 L tanks, the Ukima Plant will have a total capacity of 49,000 L bioreactor tanks, with a consistent system from process development to production of antibody API of investigational drugs in late-stage clinical studies and initial commercial products at one site. Construction is scheduled to commence in January 2016, and the demolition of old facilities is currently underway. The productivity to continuously generate innovative drug candidates is expected to increase as a consequence of these initiatives. Correspondingly, Chugai has also reinforced its production capacity for investigational drugs, and a capital investment of 2.9 billion yen is ongoing from 2013 to 2015 at Ukima Plant to double its production capacity of antibody drugs in order to accommodate the simultaneous development of drug candidates.
License accord with Athersys terminated In a separate announcement, US clinical-stage biotech firm Athersys (Nasdaq: ASDAQ) said that its licence agreement with Chugai has been ended for the exclusive development and commercialization of MultiStem cell therapy for ischemic stroke in Japan. The parties were unable to reach an agreement on the modification of the financial terms of the agreement and on development strategy in Japan, in light of the results from the Phase II clinical study. All rights will revert to Athersys, and Athersys will retain the $10 million license fee paid by Chugai. Additionally, Athersys said that it has entered into a letter of intent with an unnamed Japanese company, accompanied by a good faith payment, to collaborate on the development and commercialization of MultiStem cell therapy for several indications in Japan, including ischemic stroke. Athersys is also in ongoing discussions with several companies about collaborating on the development and commercialization of MultiStem therapy in multiple areas, including ischemic stroke outside of Japan. Partnership remains a key part of Athersys' development strategy for MultiStem cell therapy."We believe with its new mode of action, ACE910 will contribute to the patients by offering new choice of treatment options." Tweet this "We are very pleased that the FDA has granted Breakthrough Therapy Designation to ACE910," said Chugai's Director and Executive Vice President, Dr. Yutaka Tanaka. "We believe with its new mode of action, ACE910 will contribute to the patients by offering new choice of treatment options." Hemophilia A is a disease presenting repeated severe bleeding symptoms. In this disease, the blood coagulation reaction does not proceed normally due to the deficiency or functional disorder of coagulation factor VIII. Although the regular factor VIII replacement therapy has been widely used to prevent bleeding, this intravenous treatment may develop anti-factor VIII neutralizing antibodies (inhibitors) which result in reduced effectiveness. Under these circumstances, hemophilia A is a disease with high unmet medical needs. ACE910 is a bispecific antibody created using Chugai's proprietary antibody engineering technologies for the purpose of mimicking the function of blood coagulation factor VIII, in order to provide a novel concept for the treatment of hemophilia A. The Japanese phase I / II clinical study is currently being conducted to investigate the safety and exploratory prophylactic efficacy of ACE910 for preventing bleeding with the once-weekly subcutaneous injection of ACE910 in patients both with and without inhibitors. (Chugai's press release dated June 23, 2015 on the interim results of this study: http://www.chugai-pharm.co.jp/english/news/detail/20150623083000.html) The breakthrough therapy designation was adopted as part of the FDA Safety and Innovation Act (FDASIA) enacted in July 2012 aiming at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms. The designation for ACE910 was based on the domestic phase I / II clinical study conducted with Japanese and Caucasian healthy volunteers as well as Japanese hemophilia A patients. It is the third such designation for a drug candidate developed by Chugai after alectinib (for patients with ALK- positive non-small cell lung cancer whose disease progressed on crizotinib therapy) and tocilizumab (systemic sclerosis). Development rights for regions other than Japan, Taiwan, and Korea were licensed out to F. Hoffman-La Roche, Ltd. [Headquarters: Basel, Switzerland; CEO: Severin Schwan] (hereafter, "Roche") (Roche development code: RG6013). Chugai and Roche plan to initiate a phase III global study in patients with inhibitors by the end of 2015 and a phase III global study in patients without inhibitors in 2016. Additionally, a trial in pediatric patients with hemophilia A is planned to commence in 2016. Based on its business philosophy of "innovation all for the patients," Chugai will work with Roche towards the marketing applications of ACE910 in countries around the world in order to provide the new treatment option to patients and healthcare professionals as soon as possible.
About ACE910 ACE910 is a bispecific antibody created by Chugai, and substitutes for the function of blood coagulation factor VIII, which is deficient or lowered in hemophilia A patients, by promoting factor IXa-catalyzed factor X activation as factor VIII does1) 2). ACE910 is expected to prevent bleeding irrespective of the presence of inhibitors because ACE910 has a different molecular structure from FVIII, and the interim analysis of the domestic clinical studies showed the favorable results by once-a-week subcutaneous administration of ACE910.
About Breakthrough Therapy The breakthrough therapy designation was adopted as part of the FDA Safety and Innovation Act (FDASIA) enacted in July 2012 aiming at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms. In order to grant breakthrough therapy designation, preliminary clinical evidence is required demonstrating that the drug may have substantial improvement on at least one clinically significant endpoint over existing therapies. Although breakthrough therapy designation differs from other FDA systems that expedite the development and review of pharmaceutical products, it is a system that conveys all of the benefits of the fast track designation.
About Chugai Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. In Japan, Chugai's research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai's proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Marketing are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2014 of Chugai totaled 461.1 billion yen and the operating income was 77.3 billion yen (IFRS Core basis). Additional information is available on the internet at http://www.chugai-pharm.co.jp/english.
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