Business Wire

Chugai’s Satralizumab Meets Primary Endpoint in Phase III Monotherapy Study in NMOSD

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that a phase III monotherapy study of satralizumab (development code: SA237), SAkuraStar Study (NCT02073279) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which currently has no approved treatments, has achieved the primary endpoint. The primary endpoint was time to first protocol-defined relapse in the double-blind period. A statistically significant reduction in the risk of relapse was confirmed in patients who received satralizumab, compared to those who received placebo. Furthermore, the safety profile of satralizumab was consistent with that seen in previous studies. Further details will be presented at a future medical meeting.

“We are pleased that satralizumab showed benefits also in a monotherapy setting following the previous results as add-on to baseline treatment in patients with NMOSD,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “We will work diligently to prepare for regulatory filing so that we can offer a new treatment option to patients with NMOSD as soon as possible.”

SAkuraStar Study

Summary:
A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab administered to patients with NMOSD

Primary Endpoint
Time to first protocol-defined relapse adjudicated by an independent review committee in the double-blind period

Main Secondary Endpoints
Visual Analogue Scale (VAS) score for pain
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score

Study Design:

  • About 90 male and female patients aged from 18 to 74 years were randomized.
  • Patients were randomized to either of the following two treatment groups in a 2:1 ratio. Satralizumab (120 mg) or placebo was subcutaneously administered at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals.
  • The double-blind period ended when the total number of protocol-defined relapse had reached 44 or at 1.5 years after the enrollment of the last patient, whichever occurred first.
    After completion of the double-blind period, patients in both groups were able to continue treatment with satralizumab in an open-label extension period.
  • Patients with neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with NMOSD (as defined by the diagnostic criteria in 2007) with anti-aquaporin-4 (AQP4) antibodies were enrolled.

[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 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.

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

SCG Chemicals Company chooses gPROMS modelling for digital design and operations22.3.2019 18:55:00 EETTiedote

Process Systems Enterprise (PSE), the Advanced Process Modelling company, today announced that it has signed a long-term agreement with SCG, one of the largest integrated petrochemical companies in South East Asia, to standardise on PSE’s gPROMS® modelling technology for digital design and operations. SCG applies advanced process models within digital design initiatives to explore the process decision space rapidly and effectively, in order to reduce uncertainty and make better, faster and safer design and operating decisions. This help them to accelerate innovation and optimise the design and operation of their process plants. Dr Suracha Udomsak, SCG’s Emerging Business Director and R&D Director, says, “at SCG Chemicals, advanced process modelling (APM) is a key element in our Digital Manufacturing platform. APM accelerates innovation by making the development workflow ‘faster, cheaper & safer’, which are key considerations for us. It is a core technology building block that enables u

Logicor Announces Results for Year Ended 31 December 201822.3.2019 17:29:00 EETTiedote

Logicor announces strong financial performance for the year ended 31 December Net Operating Income (NOI): €639 million, which represents year on year growth of 2.5%, reflecting our strategic focus on increasing occupancy and capturing market rental growth. Over 60% of NOI is generated in the key markets of the UK (26%), Northern Europe1 (21%) and France (15%). Gross Asset Value: €12.5 billion, a 3.3% increase in valuation, which reflects the strong performance of our portfolio, in particular in Northern Europe. EPRA Occupancy: 94.4%, with physical occupancy up 70 bps over the year, underpinned by strong growth in each of our three largest regions of the UK (+120 bps), Northern Europe (+110 bps) and France (+220 bps). LTV: 51%, down from 52% at year end 2017 following increases in property values. At year end, our debt to EBITDA ratio was 11.3x. Capital Structure In 2018 Logicor (rated BBB (Stable) by S&P) established a Euro Medium Term Note (‘EMTN’) programme and raised €1.8 billion of

Delticom AG/Mytyres.co.uk: Buying Great Value Tyres Online Doesn’t Mean Missing out on Professional Fitting22.3.2019 17:15:00 EETTiedote

Spring is just around the corner, and it’s time for drivers to start thinking about changing to summer tyres. However, a tyre check may show that your current summer tyres are getting old, worn out, or have visible damage, such as cracks or bumps. If this is the case, then it's time for a new set of tyres. The legal minimum tread depth is 1.6 mm, however experts recommend significantly more – summer tyres should be replaced even if the tread depth is 3 mm. Regardless of mileage, you should change your tyres at least every eight to ten years. This is because the rubber starts to harden, the tyres lose grip on the road, and driving performance is affected. Of course, a set of four new tyres is a significant investment – authorised workshops can often charge between 250 and 350 pounds. If you want to save money, consider the alternatives: the result is an increasing number of customers turning to online shops such as Mytyres.co.uk to buy new tyres. The market share of tyres sold online ha

Trueman Man Clinic Achieves 10000 Surgery Milestone with Its SWITCH Operation22.3.2019 16:00:00 EETTiedote

Trueman Man Clinic Network announced that the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation), has been successfully completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190322005013/en/ Trueman Man Clinic Network has been successfully completed the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation). The SWITCH Premature Ejaculation Surgery (SWITCH operation) developed in 2010 by Dr. Yang, the chief director of the Trueman Man Clinic Network, can reduce the side effects of penile neurectomy and maintain the stable reduction of the glans sensation. The Trueman Man Clinic Network is the leading hospitals for male enhancement surgeries in Korea consists of 11 clinics, with 16 doctors working. As of 2019, more than 43,000 man clinic surgeries have been performed. (Photo: Business Wire) The Trueman Man Clinic Network is the leading hospitals for m

Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible22.3.2019 14:22:00 EETTiedote

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). “Today’s submission brings us one step closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “We are incredibly grateful to the patients and investigators who participated in the MAIA clinical trial programme and look forward to working closely with the regulatory authorities to secure approval of this new combination.” The submission is supported by data from the Phase 3 MAIA (MMY3008) study, which were presented at the 60th Annual Meeting of the American

Bartek Ingredients Expands Leadership Team22.3.2019 01:35:00 EETTiedote

Bartek Ingredients Inc. recently completed a 4,000 ton/year capacity expansion for its malic and food-grade fumaric acid production facility, and today it announces the expansion of its leadership team, with the hiring of Jeff Billig as Vice President of Marketing & Business Development and Heinrich G. Schaefer as International Sales Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190321005785/en/ The global leader in malic and fumaric acid ingredients expands its leadership team. (Photo: Business Wire) Bartek’s investment in both its team and facilities reinforces its position as the leader in malic and fumaric acid globally and aligns with its mission to facilitate growth and increase global reach to better serve existing customers and markets while opening up new ones. Bartek’s addition of Billig and Schaefer lays the foundation for additional resource investment in the near future while rapidly increasing its sa

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