CHUGAI PHARMACEUTICAL CO., LTD TOKYO, May 21, 2018 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that full results from the HAVEN 3 study (NCT02847637) and HAVEN 4 study (NCT03020160) evaluating Chugai's hemophilia A treatment HEMLIBRA®[generic name: emicizumab (genetical recombination)] are being presented at the World Federation of Hemophilia 2018 World Congress held in Glasgow, Scotland from May 20 to 24. HAVEN 3 study is conducted in people with hemophilia A without inhibitors, and HAVEN 4 study is conducted in people with hemophilia A with or without inhibitors. Results from both studies will be presented as late-breaking abstracts.
'The results from HAVEN 3 study demonstrate that HEMLIBRA, which was created with Chugai's proprietary antibody engineering technologies, can reduce the bleeding risk in people with hemophilia A without inhibitors. The intra-patient comparison in this study also shows a statistically significant reduction in bleeding by HEMLIBRA prophylaxis compared to factor VIII therapy, the current standard treatment,' said Chugai's President & CEO, Tatsuro Kosaka. 'In addition, HAVEN 4 data indicates that regardless of the presence of inhibitors, HEMLIBRA administration once every four weeks can reduce the risk of bleeding in people with hemophilia A compared with existing treatments. We will closely work with Roche to obtain approval of HEMLIBRA for the treatment of hemophilia A without inhibitors as early as possible.'
HAVEN 3 Study
Study description
HAVEN 3 study is a randomized, multicentre, open-label phase III study evaluating the efficacy, safety and pharmacokinetics of HEMLIBRA prophylaxis subcutaneous injection once a week and once every two weeks. The study enrolled 152 patients with hemophilia A, 12 years of age or older without inhibitors to factor VIII, who were previously treated with episodic or prophylactic factor VIII therapy.
- Primary endpoint: number of treated bleeds over time with HEMLIBRA prophylaxis (Arm A and Arm B) versus no prophylaxis (Arm C).
- Secondary endpoints: all bleed rate, treated spontaneous bleed rate, treated joint bleed rate, treated target joint bleed rate, health-related quality of life (HRQoL) / health status with HEMLIBRA prophylaxis (Arm A and Arm B) versus no prophylaxis (Arm C); intra-patient comparison to bleed rate and safety on their prior prophylactic factor VIII therapy (Arm D); and safety etc.
Study design n=152
-
Patients previously treated with episodic factor VIII therapy were randomized in a 2:2:1 fashion to either Arm A, B or C
Arm A
(n=36)Received HEMLIBRA prophylaxis at 3 mg/kg by once-weekly subcutaneous injection for 4 weeks, followed by 1.5 mg/kg once-weekly subcutaneous injection Arm B
(n=35)Received HEMLIBRA prophylaxis at 3 mg/kg by once-weekly subcutaneous injection for 4 weeks, followed by 3 mg/kg once every two weeks subcutaneous injection Arm C
(n=18)No prophylaxis control arm -
Patients previously treated with factor VIII prophylactic were enrolled in:
Arm D
(n=63)Received HEMLIBRA prophylaxis at 3 mg/kg by once-weekly subcutaneous injection for 4 weeks, followed by 1.5 mg/kg once-weekly subcutaneous injection
Summary of the HAVEN 4 (NCT03020160) study results presented at WFH
| Study Description | A single-arm, multicentre, open-label, phase III study evaluating the efficacy, safety, and pharmacokinetics of subcutaneous administration of HEMLIBRA dosed every four weeks. | ||
| Patients |
12 years of age or older patients 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. N=48 | ||
| Primary endpoint | bleed rate with HEMLIBRA prophylaxis | ||
| Study group | HEMLIBRA prophylaxis (n=48 total; n=41 included in efficacy analyses) | ||
| Treated bleeds (primary endpoint) | |||
|---|---|---|---|
| ABR, model based (95% CI) |
2.4 (1.4; 4.3) | ||
| Median ABR, calculated (IQR) |
0.0 (0.0; 2.1) | ||
| % patients with zero bleeds (95% CI) |
56.1 (39.7; 71.5) | ||
| % patients with zero to three bleeds (95% CI) |
90.2 (76.9; 97.3) | ||
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 totalled 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.
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Contact:
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Tomoko Shimizu
Tel: +81-3-3273-0881
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Chugai Pharma USA Inc.
Casey Astringer
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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
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Chugai Pharmaceutical Co. Ltd. published this content on 21 May 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 21 May 2018 07:29:00 UTC
