Business Wire

Chugai's Emicizumab Every Four Weeks Showed Positive Interim Results in Phase III Study

Del

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that positive interim results have been reported from the global phase III HAVEN 4 study (NCT03020160) for emicizumab (ACE910) subcutaneous injection, every four weeks, in patients with hemophilia A (12 years of age or older) with and without inhibitors to factor VIII. This study aims to evaluate the efficacy, safety and pharmacokinetics (PK) of emicizumab prophylaxis. At this interim analysis after a median of 17 weeks of treatment, emicizumab prophylaxis demonstrated a clinically meaningful control of bleeding over time.

These results from HAVEN 4 are consistent with previous studies of emicizumab dosed once weekly or every two weeks to evaluate the reduction of bleed rate, including the pivotal studies in hemophilia A with inhibitors, phase III HAVEN 1 study (NCT02622321) in adults and adolescents and phase III HAVEN 2 study (NCT02795767) in children, as well as the phase III HAVEN 3 study (NCT02847637) in adults and adolescents (12 years of age or older) with hemophilia A without inhibitors. The most common adverse events with emicizumab were injection site reactions, with no new safety signals observed. No thrombotic microangiopathy or thrombotic events have been reported in this study. Further details will be presented at a future medical meeting. These results will be submitted to health authorities around the world for approval consideration.

“If emicizumab prophylaxis once every four weeks is proven to be effective in controlling bleeding regardless of the inhibitor status to factor VIII, it would advance the possibility to further prolong the administration interval of emicizumab,” said Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “These interim results represent the potential to ease the burden surrounding hemophilia treatment experienced by patients or their family in their daily life and to increase the medical value of emicizumab.”

Emicizumab is an investigational bispecific monoclonal antibody, which was developed using Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor lXa and factor X. In doing so, emicizumab provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor Vlll1,2). In November this year, the drug (US product name: HEMLIBRA®; Genentech) was approved by the U.S. Food and Drug Administration “for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors”. An EU marketing authorization application was submitted in June 2017 and is being reviewed under Accelerated Assessment by the European Medicines Agency. In Japan, emicizumab obtained an orphan drug designation in August 2016 from the Ministry of Health, Labour and Welfare for the prevention and reduction of bleeding episodes in patients with congenital factor VIII deficiency (hemophilia A) who developed inhibitors to FVIII, followed by an application for regulatory approval filed in July 2017.

About HAVEN 4 study (NCT03020160)
HAVEN 4 study is a single-arm, multicentre, open-label, phase III study evaluating the efficacy, safety, and pharmacokinetics of subcutaneous administration of emicizumab dosed every four weeks. The study included 48 patients (12 years of age or older) with hemophilia A with or without inhibitors to factor VIII who were previously treated with either on-demand or prophylactic factor VIII or bypassing agents, depending on their inhibitor status. The primary endpoint of the study is the bleed rate with emicizumab prophylaxis and secondary endpoints include joint bleed rate, target joint bleed rate, health-related quality of life (HRQoL)/ health status, and safety.

[Study Design]
Patients with or without inhibitors to factor VIII previously treated with either on-demand or prophylactic factor VIII or bypassing agents were enrolled in two cohorts. The study was conducted in two stages as follows;

 
Patients   Objective   Treatment Regimen

Pharmacokinetic
(PK) run-in
cohort
(n=7)

Evaluate pharmacokinetics Received emicizumab prophylaxis at 6mg/kg once every 4 weeks

Expansion
cohort
(n=41)

  Evaluate efficacy and safety   Received emicizumab prophylaxis at 3mg/kg once every week for 4 weeks, followed by 6mg/kg once every 4 weeks
 

The evaluation of pharmacokinetics was conducted after monitoring all seven patients in a PK run-in cohort at least six weeks since they had initiated the administration of emicizumab, and followed by an expansion cohort study. Episodic treatment of breakthrough bleeds with factor VIII therapy was allowed per protocol.

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 2016 of Chugai totaled 491.8 billion yen and the operating income was 80.6 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.

References
1) Kitazawa, et al. Nature Medicine 2012; 18(10): 1570
2) Sampei, et al. PLoS ONE 2013; 8: e57479

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Koki Harada
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Paul Mignone
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, Osamu Kagawa
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

Wound Care: Nexodyn® AOS Comes to Fruition in Slovakia11.12.2018 10:30Pressemelding

Nexodyn® AcidOxidizing Solution (AOS), the Tehclo-based product for acute and chronic wound management, is now available in Slovakia, promoted and commercialized by the pharmaceutical companies Evopharm and Sanomed, pursuant to an exclusive partnership with the Swiss pharma company APR Applied Pharma Research s.a. (“APR”). After Slovakia, in early 2019 Evopharm will expand the distribution of the product first to Poland, where the registration is currently being completed, and then to Czech Republic. As confirmed by the results of pre-launch activities, Evopharm is confident that Nexodyn® AOS, based on APR’s proprietary and patented technology Tehclo®, can offer to Slovak Healthcare Professionals (“HCPs”) and caregivers a new treatment option to effectively address the wound healing complexity. Local KOLs, involved in an Advisory Board, got particularly impressed from the distinctive physico-chemical properties of this product, able to create the ideal microenvironment to sustain the p

Kao Data Invests in euNetworks High Density Fibre as Part of a North London Artery11.12.2018 09:07Pressemelding

Kao Data, the home of innovation and UK’s leading entrant to the wholesale colocation market, has announced it is working with euNetworks, a Western European bandwidth infrastructure provider. This enables the delivery of high-density fibre and duct to the Kao Data, Harlow based data centre campus north of London. The new infrastructure provides unique routing opportunities, taking advantage of Harlow’s strategic location between core hyperscale campuses in Dublin and Amsterdam. It also offers fast connection to Slough, to the West of London, and Docklands in the East of London. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005308/en/ Kao Data Invests in euNetworks High Density Fibre as Part of a North London Artery (Photo: Business Wire) As the UK continues its strong position in the international data centre market, a series of significant investments in high-density fibre routes are underway to support hyperscale d

WaveOptics Raises $26m to Scale Business and Support International Expansion in Its First Stage of Series C Funding11.12.2018 08:00Pressemelding

WaveOptics, the world leading designer and manufacturer of diffractive waveguides for use in Augmented Reality (AR) wearables, has raised $26 million (£20m) from existing shareholders and new investors. The capital raised will be used to scale up the business operations on a national and international basis. This round was led by Octopus Ventures, one of WaveOptics’ largest shareholders and one of Europe’s most prominent venture capital firms. The fundraise was supported by other existing shareholders including IP Group, Robert Bosch Venture Capital and Gobi Partners, as well as new investors Goertek and Optimas Capital Partners. David Hayes, WaveOptics CEO, commented: “We have made excellent progress over the last year with our high performing, manufacturable, and versatile waveguides. We are now working with a wide range of leading global OEMs and ODMs as they ramp up the development of their products. “These additional funds will enable us to scale up rapidly around the world, parti

Spirent Helps High-Speed Setup For Aston Martin Racing11.12.2018 08:00Pressemelding

Spirent Communications plc (LSE:SPT), the world leader in test, measurement, assurance, and analytics solutions for next-generation devices and networks, today announced that Aston Martin Racing (AMR) is using its Test as a Service (TaaS) platform, iTest, to assist the iconic automotive brand’s bid for FIA World Endurance Championship GTE category success. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005239/en/ Spirent's technical partnership with Aston Martin Racing has dramatically reduced the team's high-speed LAN test and set-up time at FIAWEC events. (Photo: Business Wire) Aston Martin Racing deploys a high-speed local area network (LAN) trackside to connect team drivers and cars with the pit crew, engineers and managers on pit lane, to carry radio communications, telemetry and video data. The FIAWEC Super Season includes some of the world’s most grueling tests of driver and car – including the famous Le Mans 24

Yamaha Motor Outline of Long-term Vision & New Medium-term Management Plan11.12.2018 06:05Pressemelding

Yamaha Motor Co., Ltd. (TOKYO:7272) announced today that it has formulated its long-term vision until 2030, and a New Medium-term Management Plan for the three-year period starting in 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181210005244/en/ (Photo: Business Wire) For its long-term vision, Yamaha Motor has created the slogan “ART for Human Possibilities” and devised a growth strategy heading for 2030. For increasingly diversifying people's values and the environment around societies, the Company will implement its growth strategies while promoting solutions to social issues based on its own historical values. While maintaining the earning power from existing businesses, the new medium-term management plan will allocate resources to strategic growth areas such as new business, and work toward achieving consolidated net sales of 2-trillion yen and a consolidated operating income of 180 billion yen. View source vers

Egon Zehnder Global Board Diversity Tracker Suggests Gender Parity in the Boardroom May Never Be Achieved11.12.2018 06:01Pressemelding

Egon Zehnder, the world's leadership advisory firm, today released the results of its 2018 Global Board Diversity Tracker. The study shows the accelerating growth seen in female directors in Western Europe is now levelling off, and growth elsewhere remains sluggish, suggesting gender parity on boards may never be reached at the current pace. The research, examining data from 1610 public companies with market caps above €7bn in 44 different countries, shows that despite the slow improvement in the number of women on boards, nearly three quarters of all new board positions worldwide still go to men. Jill Ader, Chairwoman of Egon Zehnder, said: “We need diversity, but it’s simply not happening fast enough. New voices and perspectives are essential to unlock the transformational capabilities that businesses tell us they need. Companies - starting from the very top - have to recognize the impact that a critical mass of women on the board and the executive committee makes and take the steps