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

Jaa

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Warm welcome for ABB Formula E in Davos19.1.2019 12:00Tiedote

Just a few days before the start of the World Economic Forum 2019, Davos is celebrating a world premiere: The latest ABB FIA Formula E racing car - dubbed Gen2 – was transported on a train from the iconic Swiss Rhaetian Railway to Europe’s highest city, where it will be an exciting eyecatcher during the coming week at the Davos Platz railway station. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190119005003/en/ ABB FIA Formula E racing car in Davos (Photo: Business Wire) From this Saturday until next Sunday, January 27, the Gen2 will be on display in a special glass case. Interested passersby can learn about the ABB FIA Formula E racing series as well as about the activities of ABB in e-mobility via an information system. With over 8,500 fast charging stations installed in 70 countries around the world, ABB is the global market leader for charging infrastructures. To watch the video, click here ABB (ABBN: SIX Swiss Ex) is

PMI’s Mission Winnow Goes Full Throttle with Ducati Corse for 2019 MotoGP™18.1.2019 20:00Tiedote

Philip Morris International Inc. (PMI) (NYSE: PM) is pleased to announce that its Mission Winnow initiative is expanding in 2019 to include the Ducati Corse racing team. Mission Winnow is a PMI-led campaign to raise global awareness of our passion and determination to constantly improve and evolve, as well as highlight the power of science, technology and innovation to build a better future. PMI has partnered with Ducati Corse since 2002 and has extended the relationship for another three years until the end of 2021. As of the start of this year’s MotoGP season, the team will be officially known as Mission Winnow Ducati. Mission Winnow was first launched in October 2018 with Scuderia Ferrari Mission Winnow, which – like Ducati Corse – has a passion for innovation and a relentless drive to improve in the team’s pursuit of victory. Ducati Corse is one of the most inspiring and resilient teams in MotoGP, with a 70-year history in racing. Ducati fans form a passionate community who appreci

IFF’s Frutarom Division Completes Acquisition of 60% of Thailand-based Mighty18.1.2019 15:50Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF) (TASE:IFF), announced that its Frutarom Division has completed the acquisition of 60% of the share capital of The Mighty CO. LTD. (“Mighty”), a leading savory solutions provider in Thailand, thus continuing its growth strategy in Southeast Asia. Amos Anatot, President of IFF's Frutarom Division, said, “The completion of this deal with Mighty underscores that the Frutarom division will continue on its growth strategy and pursue attractive companies that create new opportunities or build on current capabilities.” Mr. Anatot continued, “And in this case, we are helping to grow our capabilities in savory solutions – already an area of strength for legacy Frutarom, now IFF." Mighty, founded in 1989, develops, produces and markets reaction flavors, with particular expertise in savory solutions. The company’s portfolio includes flavors, seasoning blends, marinades, and specialty functional raw materials f

LTI Q3 FY19: Constant currency revenue growth up 6.1% QoQ and 20.6% YoY; Net Profit jumps 32.8% YoY18.1.2019 15:02Tiedote

Larsen & Toubro Infotech (BSE code: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q3 FY19 results today. In US Dollars: Revenue at USD 346.9 million; growth of 5.6% QoQ and 18.2% YoY Constant Currency Revenue growth of 6.1% QoQ and 20.6% YoY In Indian Rupees: Revenue at Rs 24,729 million; growth of 6.1% QoQ and 31.3% YoY Net Income at Rs 3,755 million; growth of (6.2%) QoQ and 32.8% YoY “We are pleased to deliver another strong quarter with 5.6% QoQ growth in USD revenues. Our broad-based revenue growth, superior margin delivery and steady cash generation in Q3 is a testimony of our focused execution and client centricity. We are also thrilled to welcome Ruletronics to LTI family. Ruletronics enables businesses to transform and evolve digitally by providing innovative BPM and CRM solutions leveraging Pega Platform.” - Sanjay Jalona, Chief Executive Officer & Managing Director, LTI Recent Deal Wins Nets, the leading payments company in th

Schlumberger Announces Full-Year and Fourth-Quarter 2018 Results18.1.2019 15:00Tiedote

Schlumberger Limited (NYSE: SLB) today reported results for full-year 2018 and the fourth quarter of 2018. (Stated in millions, except per share amounts) Full-Year Results Twelve Months Ended Change Dec. 31, 2018 Dec. 31, 2017 Year-on-year Revenue $32,815 $30,440 8% Pretax operating income $4,187 $3,921 7% Pretax operating margin 12.8% 12.9% -12 bps Net income (loss) - GAAP basis $2,138 $(1,505) n/m Net income, excluding charges & credits* $2,261 $2,085 8% Diluted EPS (loss per share) - GAAP basis $1.53 $(1.08) n/m Diluted EPS, excluding charges and credits* $1.62 $1.50 8% Full-Year Consolidated Revenue by Area North America $11,984 $9,487 26% Latin America 3,745 3,976 -6% Europe/CIS/Africa 7,158 7,072 1% Middle East & Asia 9,543 9,394 2% Other 385 511 n/m $32,815 $30,440 8% North America revenue $11,984 $9,487 26% International revenue $20,446 $20,442 - North America revenue, excluding Cameron $9,668 $7,518 29% International revenue, excluding Cameron $17,675 $17,423 1% *These are non

FLIR Systems Awarded $89 Million Contract from French Armed Forces to Deliver Black Hornet Personal Reconnaissance System18.1.2019 14:00Tiedote

FLIR Systems, Inc. (NASDAQ: FLIR) announced today it has been awarded a contract from the French Defense Procurement Agency (DGA) in support of the French Operational Pocket Drone (DrOP) program. The contract has a ceiling value of $89 million to provide the FLIR Black Hornet® 3 nano-unmanned aerial vehicle (UAV) and Personal Reconnaissance System (PRS) to support French Armed Forces operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190118005085/en/ The French Armed Forces awarded FLIR Systems a contract to deliver the Black Hornet Personal Reconnaissance System for military operations. (Photo: Business Wire) The Black Hornet PRS is the world’s smallest combat-proven nano-Unmanned Aerial System (UAS) and is currently deployed in more than 30 countries. The Black Hornet enables the warfighter to maintain situational awareness, threat detection, and surveillance no matter where the mission takes them. Equipped with el

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme