Business Wire

Chugai's Satralizumab Receives FDA Breakthrough Therapy Designation for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD).

“Satralizumab is a recycling antibody created utilizing Chugai’s proprietary antibody engineering technologies. We are delighted by the FDA’s designation for this innovative antibody based on the results of a Chugai-initiated global Phase III study” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “Satralizumab is designed to inhibit signaling of the inflammatory cytokine IL-6, which is known to play a role in the pathogenesis of NMO/NMOSD. We continue our efforts to hopefully bring satralizumab as a new treatment option as soon as possible to people living with this devastating disease with no approved drugs.”

The designation for satralizumab is based on data from the Phase III study (SAkuraSky study, NCT02028884) evaluating satralizumab added to baseline therapy. This is the seventh Breakthrough Therapy Designation received for four drugs created by Chugai.

[Reference]
Press release issued on October 15, 2018
Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018
https://www.chugai-pharm.co.jp/english/news/detail/20181015120001_561.html

About Breakthrough Therapy

Breakthrough Therapy Designation was adopted as part of the FDA Safety and Innovation Act (FDASIA) enacted in July 2012 aiming at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms. In order to grant Breakthrough Therapy Designation, preliminary clinical evidence is required demonstrating that the drug may have substantial improvement on at least one clinically significant endpoint over existing therapies. Breakthrough Therapy Designation includes the features of a Fast Track designation, with the addition of intensive guidance on efficient drug development as well as organizational commitment from FDA.

About Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis optica spectrum disorder (NMOSD) is a rare, lifelong, and debilitating autoimmune disease of the central nervous system (CNS) characterized by inflammatory lesions in the optic nerves and spinal cord. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, and loss of quality of life. In some cases, attacks of NMOSD result in death.

NMOSD pathogenesis is thought to involve AQP4-IgG autoantibody entry into the CNS, however approximately one-third of patients with NMOSD are AQP4-IgG seronegative1)-4). The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis.

Diagnostic criteria introduced in 2006 for neuromyelitis optica were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD was further revised to include a broader spectrum of disease. The diagnostic term NMOSD is now widely used5).

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.

 
References
1.   Jarius S, Ruprecht K, Wildemann B et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J Neuroinflammation 2012;9:14.
2. Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12.
3. Marignier R, Bernard-Valnet R, Giraudon P et al. Aquaporin-4 antibody-negative neuromyelitis optica: Distinct assay sensitivity-dependent entity. Neurology 2013;80:2194-200.
4. Takahashi T, Fujihara K, Nakashima I et al. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre. Brain 2007;130:1235-43.
5. Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.
 

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

Eurosport Signs an Exclusive Multi-Year Partnership Deal with Outbrain, Which Includes Outbrain’s Smartfeed and Video Technology16.1.2019 14:00Tiedote

Outbrain, the world’s leading native advertising platform, announced today it has signed a pan-regional deal with Eurosport, the number one destination for sports fans. The agreement spans 13 markets globally, including the UK, France, Germany, Italy, Spain, Asia, and Australia, and will be powered by Outbrain’s innovative Smartfeed technology. Smartfeed provides a content discovery feed that allows publishers to customise the user experience, improving both engagement and revenue. It is designed for a range of content from promoted articles to editorial pieces to videos, and functions across all devices including desktop, mobile, and apps. Eurosport will also utilise Outbrain’s Amplify platform to promote their own videos. Earlier this year, Outbrain released Focus, a click-to-watch video experience built for engagement and performance, and tailored for high quality and long form video content. Focus consistently results in higher click-through and completion rates, which makes it ide

Knopp Biosciences Expands Research Collaboration with Cincinnati Children’s to Characterize Effect of Dexpramipexole in Inflammatory Diseases16.1.2019 14:00Tiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with a high unmet need, today announced the expansion of its research collaboration with Cincinnati Children’s Hospital Medical Center to further elucidate the eosinophil-depleting mechanism of action of Knopp’s lead investigational drug, dexpramipexole. Eosinophils are white-blood cells that play a central role in several debilitating conditions, including asthma, hypereosinophilic syndrome (HES), and other inflammatory diseases. Dexpramipexole has been shown to selectively reduce eosinophil levels in multiple clinical trials, including a Phase 2 study in HES and a Phase 2 trial in chronic rhinosinusitis with nasal polyps. Knopp is advancing dexpramipexole into Phase 2 development in severe asthma and Phase 3 development in HES. The research at Cincinnati Children’s Hospital Medical Center is being led by Patricia C. Fu

NexPlayer Supporting Low Latency HLS & DASH Streaming on Android, iOS, Smart TVs, STBs, PCs, and Macs16.1.2019 12:52Tiedote

As part of their mission to provide the most advanced feature set, NexPlayer has added low latency functionality to its media players. NexPlayer allows you to enable low latency streaming with HLS and DASH on all devices, solving the latency problem and improving the OTT viewing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005301/en/ Latency is a serious issue for streaming services, as live playback with HLS and DASH typically falls 30 seconds to a minute behind the live event. With linear TV only 6 seconds behind, OTT viewers find out what happens via social media or text before seeing it firsthand. Now with the support of NexPlayer, media organizations can achieve sub-6 second latency on Android, iOS, Smart TVs, STBs, PCs, and Macs. In the past, the only ways to achieve low latency were through proprietary end-to-end protocols or by foregoing ABR support. Both methods have considerable drawbacks. Propr

Temenos Revolutionises its Banking Software, with the Launch of Two New Cloud-Native, Cloud-Agnostic Products – Temenos Infinity & Temenos T24 Transact to Accelerate Cloud Adoption16.1.2019 11:43Tiedote

Temenos (SIX: TEMN) the banking software company, today marked a major milestone with the launch of two new products. Temenos Infinity – a breakthrough digital front office product and Temenos T24 Transact – the next generation in core banking. These new products combine the most complete banking functionality in the market, leveraging 25 years of functionality from 3,000 banks in over 150 countries with the most advanced cloud-native, cloud-agnostic, API first technology and design-led thinking. Through APIs, both products can be implemented independently or integrated. Clients will be able to roll-out new applications in hours utilising advanced continuous deployment tools and methodologies. The conversion from Temenos’ existing Digital Front Office and T24 Core Banking products are automatic and upgrades for existing clients to the new cloud-native, cloud-agnostic Temenos products are available from April 2019. All Temenos SaaS products run on the new Temenos platform. Temenos Infin

Urban Airship Acquires Accengage, Extending Its Worldwide Leadership with Unmatched Presence Across Europe16.1.2019 11:30Tiedote

Digital customer engagement company Urban Airship today announced that it has acquired Accengage, continental Europe’s largest provider of mobile CRM and push notifications. Together Urban Airship and Accengage now form the world’s largest mobile customer engagement company, with rapidly growing solutions for apps, websites, SMS, email, mobile wallets and other channels. Customers from each company will quickly benefit from access to new technology and expanded engineering resources, as well as support from Europe’s largest team of digital customer engagement experts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005215/en/ Urban Airship customers include 25 percent of the Fortune 100 with companies such as Adidas, ASOS, BBC, Caesars Entertainment, Jet Airways, Shop Direct, Vodafone and Zeit Online. Accengage adds hundreds more global brands including Air France-KLM, Lidl, Mediaset España, OUI.sncf, Orange, Sephora Eu

OpenGate Capital Launches OGx Digital Transformation Capability16.1.2019 11:00Tiedote

OpenGate Capital, a global private equity firm, announced today that it has launched OGx, a newly formed digital innovation and business transformation growth capability as part of the firm’s commitment to untap the full potential of its acquired businesses. Developed during 2018, OGx represents the combined power of the firm’s operational excellence best practices with applied exponential technologies and business model innovation to yield the XPotential™ for select investments. Andrew Nikou, OpenGate Capital’s founder and CEO stated, “We are constantly looking for innovative and differentiated ways to accelerate profitable growth in the businesses we acquire. We are excited to launch OGx after successfully piloting it during 2018, recognizing that in this age of increased technology and business disruption, sustainable and scalable value creation within our holding period must go well beyond traditional operating drivers. We believe that a great deal of upside can be created from tak

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