Cerebral vasospasm

Sosei Heptares Operational Highlights and Consolidated Results for 12 Months ended 31 December 2023

Retrieved on: 
Tuesday, February 13, 2024

Tokyo, Japan and Cambridge, UK, 13 February 2024 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the 12 months ended 31 December 2023.

Key Points: 
  • Tokyo, Japan and Cambridge, UK, 13 February 2024 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the 12 months ended 31 December 2023.
  • Chris Cargill, President & CEO of Sosei Heptares, commented: “2023 has been a transformational year for Sosei Group and the progress made by our teams across all areas of the business has been exceptional.
  • Marketing approval for PIVLAZ® in South Korea – for the prevention of cerebral vasospasm and related conditions after aneurysmal subarachnoid hemorrhage (“aSAH”) securing.
  • A Phase 1 study of NBI-1117569 has begun and a Phase 1 study of NBI-1117567 is expected to begin in 2024.

Sosei Group Announces Marketing Approval for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea

Retrieved on: 
Thursday, December 7, 2023

Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.

Key Points: 
  • Tokyo, Japan, Seoul, South Korea, and Cambridge, UK, 7 December 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
  • The MFDS approval is based on scientific and clinical data from an extensive Japanese Phase 3 program submitted by Idorsia Pharmaceuticals Korea (“IPK”), a Sosei Group company.
  • In South Korea, the Marketing Authorization of PIVLAZ™ is held by IPK and will become commercially available to patients in early 2025.
  • PIVLAZ™ received marketing approval in Japan in January 2022 and was launched in April 2022 by Idorsia Pharmaceuticals Japan ("IPJ”), also a Sosei Group company.

Sosei Heptares Operational Highlights and Consolidated Results for the Third Quarter and First Nine Months of 2023

Retrieved on: 
Friday, November 10, 2023

Tokyo, Japan and Cambridge, UK, 10 November 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the third quarter and nine months ended 30 September 2023.

Key Points: 
  • Tokyo, Japan and Cambridge, UK, 10 November 2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the third quarter and nine months ended 30 September 2023.
  • Lean, go-to-market commercial model, well positioned to scale rapidly to generate significant value from Japan and APAC (ex-China) geographic expansion.
  • Note regarding the Idorsia transaction: the quarter ended 30 September 2023 (Q3 2023) is the first period in which the Group has consolidated the financial results of Idorsia’s former Japanese and South Korean businesses.
  • Revenue totalled JPY 5,474 million (US$39.6 million*), a decrease of JPY 3,167 million (US$27.9 million) vs. the prior corresponding period.

Sosei Heptares Operational Highlights and Consolidated Results for the Second Quarter and First Half of 2023

Retrieved on: 
Friday, August 4, 2023

Tokyo, Japan and Cambridge, UK, 4 August 2023 – Sosei Group Corporation (“the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2023.

Key Points: 
  • Tokyo, Japan and Cambridge, UK, 4 August 2023 – Sosei Group Corporation (“the Company”; TSE: 4565) provides an update on operational activities and reports its consolidated results for the second quarter and first half ended 30 June 2023.
  • Sosei Heptares will explore next steps with Pfizer for the future development of lotiglipron.
  • Revenue totalled JPY 2,146 million (US$15.9 million*), a decrease of JPY 311 million (US$4.1 million) vs. the prior corresponding period.
  • Core operating loss** totalled JPY 2,720 million (US$20.2 million) vs. a core operating loss of JPY 2,378 million (US$19.4 million) in the prior corresponding period.

Sosei Heptares Acquires Idorsia’s Pharmaceuticals Business in Japan and APAC (ex-China), Accelerating its Transformation into a Fully Integrated Biopharmaceutical Company

Retrieved on: 
Thursday, July 20, 2023

This fully funded transaction is truly transformational and achieves one of our key strategic objectives, establishing the Company as a fully integrated Japan-focused biopharmaceutical business, with growing commercial sales and an expected new product launch next year.

Key Points: 
  • This fully funded transaction is truly transformational and achieves one of our key strategic objectives, establishing the Company as a fully integrated Japan-focused biopharmaceutical business, with growing commercial sales and an expected new product launch next year.
  • “The Japan pharmaceutical market, given its size, large ageing population and attractive high quality clinical development and regulatory environment is the key next step for Sosei Heptares’ growth ambitions.
  • I would also like to welcome Dr. Satoshi Tanaka and the other members of the IPJ and IPK teams to Sosei Heptares.
  • The acquisition of IPJ and IPK addresses this objective and is the conclusion of a rigorous global search by the Sosei Heptares team.

Six New Member Companies Join the International Consortium for Innovation and Quality in Pharmaceutical Development

Retrieved on: 
Monday, September 12, 2022

WASHINGTON, Sept. 12, 2022 /PRNewswire-PRWeb/ -- The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) announced the joining of six (6) new member companies at its recent Board of Directors meeting. The new members are Novo Nordisk, The Bill and Melinda Gates Medical Research Institute, Relay Therapeutics, Xencor, CSL Behring, and Idorsia. This brings the IQ Consortium membership to 44 companies.

Key Points: 
  • The IQ Consortium continues to grow and advance innovative solutions in pharmaceutical development through precompetitive collaboration.
  • WASHINGTON, Sept. 12, 2022 /PRNewswire-PRWeb/ -- The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) announced the joining of six (6) new member companies at its recent Board of Directors meeting.
  • Margaret Faul , the consortium Chair, said that "it is exciting to welcome new members to the IQ Consortium.
  • The IQ Consortium is proud to have these innovative companies join the consortium and looks forward to further collaboration in the pursuit of pharmaceutical development, technical innovation, and continued service to patients.

Idorsia announces financial results for the first half 2022 – reaching commercial stage

Retrieved on: 
Tuesday, July 26, 2022

Based on the estimated incidence of aSAH in Japan, approximately 10%of aSAH patients were treated with PIVLAZ in June 2022.

Key Points: 
  • Based on the estimated incidence of aSAH in Japan, approximately 10%of aSAH patients were treated with PIVLAZ in June 2022.
  • Daridorexant was approved by the US FDA in January 2022 and by the European Commission in April 2022.
  • Idorsia will also make the detailed results of the Phase 3 study available through scientific presentations and peer-reviewed publications.
  • The study is expected to conclude by the end of 2022, reporting results in the first quarter of 2023.

PIVLAZ (clazosentan) – Idorsia’s first commercial product – now available for patients in Japan

Retrieved on: 
Wednesday, April 20, 2022

PIVLAZ is now available to physicians to start treating patients in Japan.

Key Points: 
  • PIVLAZ is now available to physicians to start treating patients in Japan.
  • Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan today announced that PIVLAZ (clazosentan) is now available to physicians in Japan to start treating aSAH patients.
  • and President of Idorsia Pharmaceuticals Japan, commented:
    I am very proud to be launching Idorsias first product here in Japan, and Im sure it will be the first of many innovative medicines from Idorsia, which will help many patients.
  • When listing PIVLAZ, the National Health Insurance system has recognized this innovative medicine as fulfilling an important medical need for patients facing a life-threatening condition.

Rapid Medical Receives FDA Breakthrough Device Designation for Vasospasm Treatment

Retrieved on: 
Tuesday, February 15, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, today announced FDA breakthrough designation for its Comaneci embolization assist device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke.

Key Points: 
  • Rapid Medical , a leading developer of advanced neurovascular devices, today announced FDA breakthrough designation for its Comaneci embolization assist device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke.
  • View the full release here: https://www.businesswire.com/news/home/20220215005893/en/
    Comaneci is the first device that allows physicians to monitor vessel expansion, apply incremental adjustments, and enhance treatment with combination therapeutics.
  • With this unprecedented control, the FDA designated Comaneci as a breakthrough deviceoffering advantages over existing technology to improve safety and efficacy in cerebral vasospasm.
  • This breakthrough designation will help expedite the availability of Comaneci, potentially providing a safer option for these sick patients, describes James Romero, President, Americas, at Rapid Medical.

Idorsia announces financial results for 2021 – 2022 to be a transformative year – Sustainable profitability expected in 2025

Retrieved on: 
Tuesday, February 8, 2022

Idorsia created 268 new positions worldwide in 2021, bringing the total number of employees (permanent, post-doc, and apprentices) to 1176 (2020: 908).

Key Points: 
  • Idorsia created 268 new positions worldwide in 2021, bringing the total number of employees (permanent, post-doc, and apprentices) to 1176 (2020: 908).
  • My role and that of the Board is to provide direction and oversight, as well as governance of the organization.
  • We are building Idorsia with a long-term focus, and we run the company in a responsible and sustainable way.
  • In 2021, we made great strides toward realizing our vision of creating a sustainable mid-sized biopharmaceutical company based on innovation.