Business Wire

Chugai’s HEMLIBRA® Receives Priority Review Status from U.S. FDA for Hemophilia A Without Inhibitors

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the U.S. Food and Drugs Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® [US generic name: emicizumab-kxwh] for adults and children with hemophilia A without factor VIII inhibitors. The FDA is expected to make a decision on approval by 4 October, 2018. In the US, Genentech, Inc., a member of Roche Group is the BLA holder and is engaged in the development and distribution of HEMLIBRA, which was approved and launched for hemophilia A with inhibitors in November 2017.

“We are very proud that HEMLIBRA has been granted a second Priority Review for hemophilia A without inhibitors following the previous designation for hemophilia A with inhibitors, which underscores the innovation of this drug,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “In treatment of hemophilia A without inhibitors, there still remain unmet medical needs in the management of bleeding. Given this Priority Review status, we hope to be able to contribute to people with hemophilia A and their caregivers as soon as possible by providing HEMLIBRA as a new treatment option that can be administered subcutaneously with good bleeding control and eased treatment burden.”

The sBLA filing and Priority Review are based on the results of HAVEN 3 study (NCT02847637), which has been conducted with adults and adolescents with hemophilia A without factor VIII inhibitors under a collaboration between Chugai, Roche and Genentech. In EU, Roche has already filed the results to the European Medicines Agency for a supplemental indication of hemophilia A without inhibitors.

Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in safety or effectiveness of the treatment, prevention or diagnosis of a serious disease. In Japan, HEMLIBRA received regulatory approval in March 2018 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 and, in April 2018, was filed to the Ministry of Health, Labour and Welfare for a supplemental indication of hemophilia A without inhibitors.

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

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 totaled 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.

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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 17:00Tiedote

Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With

Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 16:41Tiedote

Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 15:00Tiedote

Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i

Announcement by Viking Corp on Tecnotree22.6.2018 14:09Tiedote

In the interests of stakeholder transparency, this announcement provides background and context to Viking's file bankruptcy proceedings upon Tecnotree: As many of you will now know, Viking Corp was recently forced to file bankruptcy proceedings upon Tecnotree, which were withdrawn on the 19 June. In the interests of stakeholder transparency, we make this Announcement to provide background and context to this action. Firstly, we would reflect on the recent history of our attempts to partner with Tecnotree and all its stakeholders. Viking launched a Tender Offer (TO), having conducted detailed discussions with the Tecnotree Board and our advisors. On the basis of those discussions, we were very confident that the TO price of 10 cents per share provided truly superior value for shareholders. So did the Tecnotree Board as evidenced by their unanimous recommendation of our Offer and of course, further evidenced by the current prevailing market price. This TO was supported in the most vigoro

HeartSciences Named “Start-Up to Watch”22.6.2018 14:00Tiedote

HeartSciences is delighted to have been highlighted as “Start-Up to Watch” in the June 8, 2018 issue of the MedTech Strategist. The article titled “HEARTSCIENCES: ARTIFICIAL INTELLIGENCE IMPROVES FRONTLINE RISK STRATIFICATION FOR HEART DISEASES” discusses HeartSciences’ role in addressing the current challenges and significant unmet need to identify heart disease at an early stage and reduce the high prevalence of expensive diagnostic testing with low yields. The article highlights the enormous opportunity for HeartSciences’ breakthrough MyoVista® Wavelet ECG (wavECG™) technology to benefit patients and to reduce health system costs and references a recently published study titled “Prediction of Abnormal Myocardial Relaxation From Signal Processed Surface ECG” in the Journal of American College of Cardiology (JACC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005088/en/ MyoVista Wavelet ECG Cardiac Testing Device (P

High-Performance Solutions and Complete Protection for Critical Installations: the Latest Innovations from CNIM and Its Bertin Subsidiary to Be Unveiled at WNE 201822.6.2018 12:39Tiedote

The third edition of the World Nuclear Exhibition – major event for the global nuclear energy community – will be held at Paris-Villepinte, June 26 th to 28 th , 2018. CNIM and Bertin Technologies , leading players in the fields of nuclear equipment, safe handling and instrumentation for the complete protection of nuclear power plants, will be unveiling their joint offerings at this exhibition (booth D125-Hall 7). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005185/en/ CNIM's high safety fuel handling systems (Photo: Business Wire) Based on its long experience of major nuclear projects and its cutting-edge industrial capabilities, CNIM’s offering reflects its ability to innovate and adapt to the most difficult environments. Highlights on its exhibition booth will include: The design and manufacturing of high-safety fuel handling systems (notably the design of three remotely operated spent fuel handling and transferri

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