KYOWA-KIRIN-CO.,-LTD.
12.11.2021 13:36:13 CET | Business Wire | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that following a re-examination procedure the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Parkinson’s is a chronic, progressive neurodegenerative condition that affects small regions in the brain that control movement, balance and posture.1 It is the fastest growing neurodegenerative disorder in the world.2
“We are disappointed by the CHMP opinion. We will take time to assess our plans for istradefylline in EMEA,” said Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. “We appreciate the collaboration we have had with all stakeholders and applaud the Parkinson’s community for their commitment to supporting people living with this chronic, debilitating condition.”
The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. The company is committed to bringing our innovative therapies to patients.
About istradefylline
Istradefylline was developed as a novel, first-in-class non-dopaminergic, adenosine A2A receptor antagonist that reduces ‘OFF’ time in people living with Parkinson’s through selective targeting of adenosine A2A receptors in the basal ganglia. Whilst dopaminergic treatment targets the dopamine receptors in the direct and indirect pathways to facilitate movement, istradefylline, as an add-on to L-Dopa, reduces the activity of the indirect pathway which suppresses movement.3,4 Consequently, it helps restore the balance within the basal ganglia.1,2
About Parkinson’s and ‘OFF’ episodes
There are an estimated 10 million people in the world currently living with Parkinson’s.5 Although it is classically characterised by motor symptoms (symptoms involving movement), people living with the condition also experience a large range of non-motor symptoms, which add to the complexity of living with the condition.5 Although Parkinson’s is not life threatening there is currently no cure.1 Over time symptoms progress and can be unpredictable, imposing a significant impact on daily life.1 This impact can extend to caregivers, friends and family, whose own wellbeing and quality of life can deteriorate as a result.6
‘OFF’ episodes is used to describe the return of Parkinson’s symptoms, also known as ‘OFF’ symptoms, and can be triggered by a variety of phenomena, including:7
- Delayed onset of response to medication
- Reduced duration of benefit from a medication
- Reduced or no efficacy of a dose of medication
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/ .
Kyowa Kirin International is a subsidiary of Kyowa Kirin Co., Ltd.
Kyowa Kirin International
http://www.international.kyowa-kirin.com /
Galabank Business Park
Galashiels, TD1 1QH
United Kingdom
References
1. European Parkinsons Disease Association. About Parkinson’s, https://www.epda.eu.com/about-parkinsons/what-is-parkinsons/ [Last accessed Novemeber 2021].
2. Dorsey ER, Sherer T, Okun MS, et al. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis 2018; 8: S3-s8. 2018/12/26. DOI: 10.3233/jpd-181474.
3. Saki M, Yamada K, Koshimura E, et al. In vitro pharmacological profile of the A2A receptor antagonist istradefylline. Naunyn Schmiedebergs Arch Pharmacol 2013; 386: 963-972. 2013/07/03. DOI: 10.1007/s00210-013-0897-5.
4. LeWitt PA, Aradi SD, Hauser RA, et al. The challenge of developing adenosine A(2A) antagonists for Parkinson disease: Istradefylline, preladenant, and tozadenant. Parkinsonism Relat Disord 2020; 80 Suppl 1: S54-s63. 2020/12/23. DOI: 10.1016/j.parkreldis.2020.10.027.
5. Ball N, Teo W-P, Chandra S, et al. Parkinson's Disease and the Environment. Frontiers in Neurology 2019; 10. Mini Review. DOI: 10.3389/fneur.2019.00218.
6. Armstrong MJ, Rastgardani T, Gagliardi AR, et al. The impact of off periods on persons with Parkinson’s and care partners: a qualitative study. Neurol Clin Pract 2020;10.1212/CPJ.0000000000000921.
7. Freitas ME, Hess CW and Fox SH. Motor Complications of Dopaminergic Medications in Parkinson's Disease. Semin Neurol 2017; 37: 147-157. 2017/05/17. DOI: 10.1055/s-0037-1602423.
KKI/INT/IST/0142
Date of preparation: November 2021
View source version on businesswire.com: https://www.businesswire.com/news/home/20211112005565/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
JTB to Acquire Asian DMC Leader EXO Travel for Accelerated Global Growth18.6.2026 04:00:00 CEST | Press release
— Advancing JTB's “Departing Globally, Arriving Globally” Vision — JTB Corp. today announced that it has reached an agreement to acquire all the shares of All Wise Holdings Pte. Ltd., the operator of Bangkok-based EXO Travel Group, a leading Destination Management Companies (DMCs) in Asia. The acquisition will be made through a JTB group company in the Asia-Pacific region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615106801/en/ EXO Travel operates in the B2B market, primarily across Asia Pacific. For over 30 years, it has consistently maintained high customer satisfaction based on trust, achievements and high-quality service. The company has a strong brand presence in the affluent markets of Europe, North America and Australia, where the trust of partner companies contributes significantly to its value. Additionally, EXO Travel leverages its extensive network of destinations in Asia Pacific to develop strong products
LabGenius Therapeutics and LG Chem Enter a Research Collaboration, Option and License Agreement to Develop an AI/ML-Designed Tumour-Targeting Antibody18.6.2026 01:01:00 CEST | Press release
The companies have entered into a multi-year research collaboration, option and licensing agreement in which LabGenius Therapeutics will leverage its AI/ML-driven antibody discovery platform,EVA™, to design and engineer next-generation multispecifics with enhanced therapeutic properties LabGenius Therapeutics will receive an undisclosed upfront payment and potential early milestones, plus, if the option is exercised, potential triple-digit million clinical, regulatory, and commercial milestones, along with royalties on net sales LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise therapeutic antibodies, today announced a multi-year research collaboration, option and licensing agreement with LG Chem. The collaboration aims to identify next-generation multispecific antibodies designed to overcome the key limitations of existing immunotherapies, including on-target, off-tumour toxicities. Together,
Joe Vernachio Named President of SOREL18.6.2026 00:00:00 CEST | Press release
Columbia Sportswear Company (Nasdaq: COLM), a leading innovator in active outdoor apparel, footwear, accessories and equipment, today announced that Joe Vernachio will be the next President of SOREL. Founded in 1962, SOREL is a leader in functional and lifestyle footwear that can be worn anywhere from the tundra to the streets of New York City. “We’re excited to welcome Joe Vernachio back to the Columbia Sportswear family,” said Tim Boyle, CEO and Chair of the Board. “Joe is a terrific leader who can build on the great work, talent and momentum in place at SOREL.” Mr. Vernachio led the Mountain Hardwear brand for several years, until he left to become the COO and ultimately, the CEO of Allbirds. His background also includes time as Global Vice President for Product and Operations at The North Face, and key roles at Nike, Spyder, Roots, Calvin Klein and Patagonia. “Joe is a consumer‑focused, collaborative leader with a deep passion for product and brand storytelling. His energy, experti
Venture Global and EnBW Announce New LNG Purchase Agreements17.6.2026 22:30:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and EnBW announced the execution of new, binding agreements for the purchase of approximately 0.82 million tonnes per annum (MTPA) of U.S. liquefied natural gas (LNG) from Venture Global for approximately five years commencing in 2026, to be supplied from Venture Global’s portfolio. The new agreements add to the existing long-term sales and purchase agreements (SPAs) between Venture Global and EnBW for 2 MTPA for 20 years. “As one of Germany’s top LNG suppliers, Venture Global is proud to strengthen our partnership with EnBW and support the region’s energy security with a reliable supply of LNG,” said Venture Global CEO Mike Sabel. “The new mid-term agreements build on our strong, long-standing relationship with EnBW and reflects our commitment to meeting our customers’ evolving energy needs. Our dynamic marketing platform uniquely positions us to provide supply solutions across the short, medium, and long term.” About Venture Global Venture Globa
Kinaxis Announces Results of Voting at Annual and Special Meeting of Shareholders17.6.2026 22:05:00 CEST | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, received approval for all resolutions put forward to shareholders at today’s Annual and Special Meeting of Shareholders (the “Meeting”), as detailed in the Company’s management information circular dated May 5, 2026 (the “Circular”). 1. Election of Directors Shareholders voted to elect all eight directors nominated to the Kinaxis board, to hold office until the close of the next annual meeting of shareholders of the Company or until their successors are elected or appointed. Name of Nominee Total Number of Votes For Percentage of Votes For Total Number of Votes Against Percentage of Votes Against Razat Gaurav 21,870,163 99.01% 219,468 0.99% Robert Courteau 20,882,945 94.54% 1,206,685 5.46% Gillian (Jill) Denham 21,474,486 97.22% 615,143 2.78% José Alberto Duarte 21,699,181 98.23% 390,448 1.77% Lynn Loewen 21,952,244 99.38% 137,387 0.62% Angel Mendez 21,410,402 96
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom