Business Wire

Chugai Presents Results of Two Pivotal Phase lll Studies for its Bispecific Antibody HEMLIBRA® at WFH 2018

Del

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) today announced that full results from 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 of 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
 

Episodic treatment of breakthrough bleeds with factor VIII therapy was allowed per protocol.

Summary of results

  • HEMLIBRA achieved a statistically significant reduction in treated bleeds by 96% (Wald test, p <0.0001) with once-weekly prophylaxis of HEMLIBRA (Arm A) and 97% (p <0.0001) with once every two weeks prophylaxis respectively, compared with no prophylaxis control arm (Arm C).
       

 [Major secondary endpoints and reduction rate (%)]  (Wald test)

    Arm A   Arm B
All bleeds 95%

(p <0.0001)

94%

(p <0.0001)

Treated spontaneous bleeds 94%

(p <0.0001)

98%

(p <0.0001)

Treated joint bleeds 96%

(p <0.0001)

97%

(p <0.0001)

Treated target joint bleeds   95%

(p <0.0001)

  95%

(p <0.0001)

  • 55.6% (95% CI: 38.1, 72.1) of patients receiving once-weekly prophylaxis of HEMLIBRA (Arm A) experienced zero treated bleeds and 60% (95% CI: 42.1, 76.1) of patients receiving once every two weeks prophylaxis of HEMLIBRA (Arm B) compared to 0% (95% CI: 0.0, 18.5) of those not receiving prophylaxis treatment (Arm C).
  • An intra-patient comparison (n=48) in patients who had previously treated with factor VIII prophylaxis prior to the study (Arm D) and participated in the foregoing non-interventional study (NIS) showed that 68% (RR=0.32, p <0.0001) reduction of treated bleeds with once-weekly prophylaxis of HEMLIBRA.
  • Adverse events (AEs) occurring in 5% or more of patients treated with HEMLIBRA were injection site reactions, joint pain (arthralgia), common cold symptoms (nasopharyngitis), headache, upper respiratory tract infection and influenza.
  • There were no unexpected or serious adverse events (AEs) related to HEMLIBRA and most common AE profiles appeared consistent with the known safety profile of the medicine.

HAVEN 4 Study

Study Description

HAVEN 4 study is a single-arm, multicentre, open-label, phase III study evaluating the efficacy, safety, and pharmacokinetics of subcutaneous administration of HEMLIBRA 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.

  • Primary endpoint: treated bleed rate with HEMLIBRA prophylaxis
  • 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, and safety etc.

Study design    n=48

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;

         
Cohort   Objective   Treatment Regimen
Pharmacokinetic (PK) run-in cohort

(n=7)

Evaluate pharmacokinetics Received HEMLIBRA prophylaxis at 6 mg/kg once every 4 weeks
Expansion cohort

(n=41)

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

All patients in the PK run-in cohort (n=7) were previously treated with on-demand treatment and then received HEMLIBRA prophylaxis in the study. The evaluation of pharmacokinetics was conducted after monitoring all seven patients in the PK run-in cohort for at least six weeks since they had initiated the administration of HEMLIBRA, followed by an expansion cohort study. Episodic treatment of breakthrough bleeds with factor VIII therapy was allowed per protocol.

Summary of results

  • Patients receiving HEMLIBRA prophylaxis in Expansion cohort had a median annualized bleeding rate (ABR) for treated bleeds of 0.0 (IQR: 0.0; 2.1).
  • 56.1% (95% CI: 39.7, 71.5) of patients in Expansion cohort achieved zero treated bleeds and 90.2% (95% CI: 76.9, 97.3) of patients experienced three or fewer treated bleeds.
 

 

   

[Major secondary endpoints and achievement rate (%) of zero bleeds]

  All bleeds:   29.3% (95% CI: 16.1, 45.5)
Treated spontaneous bleeds: 82.9% (95% CI: 67.9, 92.8)
Treated joint bleeds: 70.7% (95% CI: 54.5, 83.9)
Treated target joint bleeds: 85.4% (95% CI: 70.8, 94.4)
  • Results from HAVEN 4 study is consistent with results obtained from other phase III studies of HEMLIBRA. These data show that once every 4 weeks prophylaxis of HEMLIBRA can provide clinically meaningful control of bleeding in patients with hemophilia A with or without factor VIII inhibitors.
  • There were no unexpected or serious adverse events (AEs) related to HEMLIBRA and the most common AEs were consistent with previous studies.
  • Injection site reaction was the most common AE, occurring in nine people.
 

Summary of the HAVEN 3 (NCT02847637) study results presented at WFH

Study Description   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.
Patients

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.

  N=152
Primary endpoint Number of bleeds over time with HEMLIBRA prophylaxis (Arm A and Arm B) versus no prophylaxis (Arm C)
Study group   No prophylaxis

(Arm C; n=18)

  Once weekly HEMLIBRA prophylaxis

(Arm A; n=36)

  Once every 2 weeks HEMLIBRA prophylaxis

(Arm B; n=35)

Treated bleeds (primary endpoint)
Median efficacy period, weeks

(min–max)

24.0

(14.4–25.0)

  29.6

(17.3–49.6)

  31.3

(7.3–50.6)

Model-based ABR (95% CI)* 38.2

(22.9; 63.8)

1.5

(0.9; 2.5)

1.3

(0.8; 2.3)

% reduction vs arm C

(RR, Wald test; p-value)

N/A 96% reduction

(0.04, p <0.0001)

97% reduction

(0.03, p <0.0001)

Median ABR

(Interquartile range; IQR)

40.4

(25.3; 56.7)

0.0

(0.0; 2.5)

0.0

(0.0; 1.9)

% patients with zero bleeds

(95% CI)

0.0

(0.0; 18.5)

55.6

(38.1; 72.1)

60

(42.1; 76.1)

% patients with zero to three bleeds

(95% CI)

  5.6

(0.1; 27.3)

  91.7

(77.5; 98.2)

  94.3

(80.8; 99.3)

 
Treated bleeds ABR intra-patient comparison

(Arm D patients who participated in NIS, n=48; secondary endpoint)

Study group   Prior factor VIII prophylaxis

(Arm C; n=48)

  Once-weekly HEMLIBRA prophylaxis

(Arm D; n=48)

Median efficacy period, weeks

(min–max)

30.1

(5.0–45.1)

33.7

(20.1–48.6)

Model-based ABR*

(95% CI)

4.8

(3.2; 7.1)

1.5

(1.0; 2.3)

% reduction vs NIS Factor VIII

(RR, p-value)

68% reduction

(0.32, p <0.0001)

Median ABR (IQR) 1.8

(0.0; 7.6)

0.0

(0.0; 2.1]

% patients with zero bleeds 39.6

(25.8; 54.7)

54.2

(39.2; 68.6)

% patients with zero to three bleeds   72.9

(58.2; 84.7)

  91.7

(80.0; 97.7)

*Negative binomial regression model

 

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.

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

IFF Recognized by SAM’s 2019 “Industry Mover” Sustainability Award15.2.2019 21:15:00Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), was recognized for its sustainability efforts with the 2019 “Industry Mover” award from SAM, a subsidiary of RobecoSAM which specializes in providing environmental, social and governance (ESG) data, benchmarks and ratings. The recognition acknowledges the Company’s top-scoring performance in economic, social and environmental categories. “We are thrilled to receive this award from SAM,” said Andreas Fibig, IFF Chairman & CEO. “Our sustainability efforts are not only a key enabler of our overall strategy, but also a true passion here at IFF -- and we place it at the forefront of everything we do. It is deeply gratifying to have our work and our people recognized for doing the right thing for the planet.” SAM’s 2019 scoring is based on its 2018 Corporate Sustainability Assessment. Using a weighted methodology, SAM evaluates companies for criteria such as: codes of business conduct, ope

SFL: strong financial position and results in 2018, consolidating the Group’s position as a prime player15.2.2019 18:01:00Pressemelding

Regulatory News: The financial statements for the year ended 31 December 2018 were approved by the Board of Directors of Société Foncière Lyonnaise (Paris:FLY) on 15 February 2019 at a meeting chaired by Juan José Brugera. 2018 business indicators were very robust, with further underlying growth in rental income and historically high EPRA earnings. The portfolio's appraisal value and the Company's net asset value also continued to grow, attesting to SFL’s excellent positioning. The auditors have completed their audit of the annual financial information and are in the process of issuing their report. Consolidated data (€ millions) 2018 2017 Change Rental income 193.5 195.8 -1.2% Adjusted operating profit* 162.1 164.1 -1.2% Attributable net profit 351.6 685.3 - EPRA earnings 106.7 102.4 +4.1% * Operating profit before disposal gains and losses and fair value adjustments 31/12/2018 31/12/2017 Change Attributable equity 4,010 3,763 +6.6% Consolidated portfolio value excluding transfer cost

5 Happening Cultural Destinations to Visit in 201915.2.2019 10:11:00Pressemelding

Hong Kong There’s never really a sleepy year to visit Hong Kong, but 2019 is particularly ripe for visitors. Spearheaded by the dynamic entrepreneur Adrian Cheng of K11 and New World Development, the rejuvenation of Tsim Sha Tsui harbourfront is just the starting point. The city’s iconic harbourside walkway, Avenue of Stars, has just received a much-awaited makeover that’s the brainchild of Cheng and visually conceived by James Corner, the landscape architect responsible for the High Line in New York. It sees the addition of design-driven rest areas, kiosks featuring homegrown brands, hand prints from Asian film stars and interactive digital elements. Featuring Hong Kong’s first wave energy demonstrator that produces electricity for the Avenue, the place is turned into one of the most sustainable promenades in Hong Kong. This is just one part of Cheng and his company’s grander urban revitalisation plan, Victoria Dockside, a new art and design district which will fully open in the third

ISAE-SUPAERO Launches a New MOOC about Flight Mechanics15.2.2019 09:36:00Pressemelding

"ABC of Flight Mechanics: How Do Planes Fly?": a MOOC dedicated to flight mechanics. The notion of flight often defies our human terrestrial instincts. How does an airplane fly? How can a pilot maintain control? How high in the sky can an aircraft climb? How does a fighter pilot fly while spinning? This online course (available in English) will cover many topics, such as atmospheric physics and Newton's laws applied to aircraft, as well as propulsion forces and longitudinal stability the question of traction. The MOOC "ABC of Flight Mechanics" is aimed at general public with a specific level of scientific knowledge. Nevertheless, various levels of learning are available, thus it allows all students to take the course without needing to plenty understand the mathematical principles. Undergraduate students in aerospace engineering, trainees as well as novice and experienced pilots, journalists and professionals in the aeronautics domain (business, engineering, marketing, communications,

REPLY: Red Reply Wins the Oracle “Partner of the Year Autonomous” Award15.2.2019 09:30:00Pressemelding

Red Reply, the Reply group company that specialises in the Oracle Cloud IaaS and PaaS platform has been named as Oracle “Partner of the Year: Autonomous.” The award recognises Red Reply for its work as an Oracle Cloud Managed Service Provider Partner in developing highly innovative projects using the Oracle Autonomous Database technology. Red Reply has launched a project aimed at re-engineering the Policy Enterprise DataWarehouse of Verti Assicurazioni, company operating in the online insurance sector, using the Oracle Cloud Autonomous DataWarehouse service. The Autonomous DataWarehouse is a cloud-based database that uses machine learning to eliminate manual labour in operations such as tuning, security, backups, updates and other routine activities. This selected Oracle solution is the only one of its kind capable of addressing aspects such as security, performance and high availability of data, using automatic update and tuning mechanisms, while maximising the protection of data in l

Posiflex showcases new Interactive Self-Service Kiosks and IoT Retail Product Innovations at EuroCIS 201915.2.2019 08:00:00Pressemelding

The Posiflex Group — a synergy of world-leading POS, kiosk, and industrial computing technologies — will introduce its full product portfolio and latest innovations at EuroCIS, the leading trade fair for retail technology, from February 19th – 21st in Düsseldorf. With a product strategy focus on serviced IoT, the Posiflex Group will be displaying smart and connected retail solutions with fully-integrated middleware, RMS (Remote Monitoring System) and hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190215005008/en/ Posiflex at EuroCIS Hall 9 / C42 (Graphic: Business Wire) “I am excited to introduce the Posiflex Group portfolio to the European market,” says Hans Peter Nüdling, the newly appointed Chief Strategy Officer for the Posiflex Group. “The Posiflex Group references the collective brands of the corporation, including Posiflex, Portwell and KIOSK Information Systems (KIOSK) – all under one corporate umbrella. As