Business Wire

Results of Global Phase III Study with Chugai's HEMLIBRA® for Hemophilia A Without Inhibitors Published in the New England Journal of Medicine

Del

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) today announced that results of the HAVEN 3 study (NCT02847637), the global phase III study evaluating hemophilia A treatment, HEMLIBRA® (generic name: emicizumab [genetical recombination]), were published in the 30 August 2018 issue of the New England Journal of Medicine (NEJM).
Article: https://www.nejm.org/doi/full/10.1056/NEJMoa1803550
Quick video summary by NEJM: https://www.nejm.org/do/10.1056/NEJMdo005333/full/

The study evaluated the efficacy and safety of HEMLIBRA subcutaneous injection, once a week and once every two weeks, in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII. Detailed results of the study were presented at the World Federation of Hemophilia (WFH) 2018 World Congress held in Glasgow, Scotland on May 21, 2018.

“This is the third time that the clinical data of HEMLIBRA have been published in NEJM, following the results of the phase I/II studies and the first phase III study. It demonstrates a high medical value that the drug may bring to the treatment of hemophilia A,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “We are committed to deliver HEMLIBRA which has been created with our proprietary bispecific antibody technologies, as a new treatment option to people with hemophilia A without inhibitors as early as possible in cooperation with Roche.”

In May 2018, HEMLIBRA was launched in Japan for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with congenital factor VIII deficiency (hemophilia A) with factor VIII inhibitors. An application for an additional indication of the treatment of hemophilia A without factor VIII inhibitors has been filed in April in Japan. Applications for the same additional indication have also been filed in the United States and Europe. In the U.S., the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation in April, and Priority Review in June, for this line extension. In Europe, the review by the EU Committee for Medicinal Products for Human Use (CHMP) is ongoing.

Reference

Chugai Presents Results of Two Pivotal Phase III Studies for its Bispecific Antibody HEMLIBRA at WFH 2018 (Press release issued on May 21, 2018)
https://www.chugai-pharm.co.jp/english/news/detail/20180521160000.html

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 Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2017 of Chugai totalled 534.2 billion yen and the operating income was 103.2 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

Trademarks used or mentioned in this release are protected by law.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Tomoko Shimizu
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
***
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
E-mail: pr@chugai.eu
***
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw
***
For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

L4MS Launches Its First Open Call for Cross-Border Application Experiments20.9.2018 10:30Pressemelding

The European Project L4MS (Logistics for Manufacturing SME’s) is looking for European manufacturing SME’s and mid-caps to develop new, innovative solutions to boost their factory-floor logistic. As a Factories of the Future (FoF) project participating in I4MS (ICT for Manufacturing SMEs) and with the support of the European Union's Horizon 2020 research and innovation programme, the aim of L4MS project is to reduce the installation cost and time of mobile robots by a factor of 10. It will enable inexpensive deployment of small and flexible logistics solutions requiring no infrastructure change, no production downtime and no in-house expertise. In addition to equity-free funding, the companies will receive extensive technological support from the L4MS network. The best applicants with highest innovation potential will get access to: Matchmaking with system integrators and mobile robots manufactures, funding up to €250,000, state-of-the-art test environment within your region, mentoring

Uphold Makes Cred’s LBA Tokens Available For Purchase in 170+ Countries20.9.2018 10:00Pressemelding

Uphold, the global digital money platform that has powered more than $3.5 billion in transactions across 184 countries, and Cred, the leader in crypto-backed credit, today announced the next step in their commercial relationship which will allow Uphold users access to LBA tokens on the Uphold platform. “Cred has secured more lending capital than any other lending company in the space by orders of magnitude,” said JP Thieriot, CEO of Uphold. “Our ability to offer Cred’s LBA token is another important milestone for our members since Cred is one of the fastest growing lending ecosystems in the crypto community. Uphold members will have access to fiat loans at a lower cost via the LBA token. Cred’s lending services can also provide a financial lifeline to the many ICO companies that have raised a significant amount of ETH and BTC and would like to receive a USD loan to diversify their balance sheets and avoid having to sell at diminished prices.” Cred and Uphold will offer two special arra

Ant Financial Launches Ant Financial Technology Brand with Full Suite of Technology Products and Services to Support Growth of Financial Institutions20.9.2018 09:43Pressemelding

Ant Financial Services Group (“Ant Financial” or “the Company”) today announced that the Company would open up a full suite of technology products and services under a new brand, Ant Financial Technology, to support the growth of financial institutions by improving user experience and lowering costs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005319/en/ Ant Financial launches Ant Financial Technology, a new brand supporting the growth of financial institutions, at ATEC 2018 in Hangzhou, China. (Photo: Business Wire) Announcing the launch of the Ant Financial Technology brand at the 2018 Ant Technology Exploration Conference (ATEC) in Hangzhou, Xi HU, Deputy CTO of Ant Financial said, “Since our establishment in 2014, Ant Financial has focused on developing cutting edge technologies to enable inclusive finance. We are pleased that our technology products and services have already been used to improve efficiency and

Invengo Releases Latest Version of Its ACUITY Digital Platform for Linen Inventory Management20.9.2018 08:00Pressemelding

Invengo today announced hot new improvements to its ACUITY digital platform, underscoring its commitment to help laundry groups, hotels and healthcare facilities take full control over their linen inventories, anywhere and at any time. This new milestone release is a significant leap forward from its previous version, taking linen professionals one step further with 100% automatic real-time linen stock visibility, enabling stock levels optimization and availability through cloud-based reporting, dashboards and data analysis. This latest version of ACUITY provides a superior full cloud-based, software-as-a-service (SaaS) offering for companies seeking a plug-and-play solution, significantly reducing total cost of ownership, technical complexity, and setup time, while providing users with instant access to their linen management platform through a web browser on any device. This eliminates the hassle of hosting and maintaining their own server and dealing with software updates while enjo

Alibaba Announces Smart Mobility Initiatives with Partners20.9.2018 07:17Pressemelding

Alibaba Group Holding Limited (NYSE: BABA) announced today a series of smart mobility initiatives in partnership with auto brands and technology service providers. The announcement was made during The Cloud Computing Conference, the company’s largest technology showcase, held over four days in Hangzhou, Alibaba’s home base. Partnering with Bosch on Automated Valet Parking Alibaba Cloud, the cloud-computing arm of Alibaba Group, and Bosch, a leading global supplier of technology services, announced plans to introduce Automated Valet Parking (AVP) solutions in China. Both parties will work together to enable the infrastructure-based, driverless parking solution. The technology is powered by software in a cloud and it will offer a fully automated valet parking service in the near future. As part of the cooperation, Bosch will provide its AVP technology, its experience in systems engineering and its IoT competencies. Alibaba Cloud, meanwhile, will share its technologies and its experience

Egon Zehnder and Mobius Executive Leadership Formalize Exclusive Strategic Partnership20.9.2018 06:01Pressemelding

Egon Zehnder, the world’s leadership advisory firm, has entered into a formal partnership with Mobius Executive Leadership, the US and Europe-based premier leadership development firm. The partnership combines the firms’ proprietary methods for accelerating the personal and professional development of senior executives and for stimulating an organization’s ability to transform. “Readiness to lead at the top levels in business and society today requires leaders develop a willingness to understand who they are and who they can become so that they can unlock their full potential – and help their organizations unleash their potential as well,” stated Jill Ader, Egon Zehnder’s Chair-Elect and Co-developer of the Executive Breakthrough Program. “Together with Mobius, we have found success in doing that.” Already collaborating for more than four years, the two firms’ new partnership formally combines Egon Zehnder’s deep leadership advisory experience to the world’s most influential leaders an