TOKYO--(BUSINESS WIRE)--Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, �Kyowa Kirin�) today announced that 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. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson�s and are currently reviewing the options available, which may include re-examination.

�We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson�s, an area which has had few innovative therapies for decades,� said Abdul Mullick, President of Kyowa Kirin International. �There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson�s, and we believe that istradefylline offers people living with the condition a chance to regain some control over the management of their �OFF� time. We remain committed to pursuing the registration of istradefylline in the EU.�

�Parkinson�s is a complex condition that affects every person living with it differently and is characterised by a broad range of symptoms that can significantly impact their quality of life,� said Professor Heinz Reichmann, Professor and Chair of the Neurology Department at the University of Dresden. �There is currently an urgent need for innovative treatments such as istradefylline for people living with Parkinson�s, to support them and their families in reducing their �OFF� time. I hope that the CHMP will reconsider their position on istradefylline.�

�First of all, I would like to appreciate those who have contributed to the development of istradefylline.� Said Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. �Although unfortunately it is a negative opinion from the CHMP this time, we will continue to think of how we can contribute to people living with Parkinson�s and their families as we do in the US and Japan.�

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.

About istradefylline

Istradefylline is a novel, first-in-class non-dopaminergic, adenosine A_2A receptor antagonist that reduces �OFF� time in people living with Parkinson�s through selective targeting of adenosine A_2A 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. Therefore, it helps restore the balance within the basal ganglia.^1,2

Istradefylline has been approved for use in Japan by the Ministry of Health, Labour and Welfare since 2013, under the brand name of NOURIAST^�. In August 2019 it also received approval from the U.S. Food and Drug Administration (FDA) as adjunctive treatment to levodopa / carbidopa in adult patients with Parkinson�s experiencing �OFF� episodes and is marketed under the name of NOURIANZ^�.^3,4

About Parkinson�s and �OFF� episodes

Parkinson�s is a chronic, progressive neurodegenerative condition that affects small regions in the brain that control movement, balance and posture.⁵ It is the fastest growing neurodegenerative disorder in the world,⁶ with an estimated 10 million people in the world currently living with the condition.⁷ Although it is classically characterised by motor symptoms (symptoms involving movement), people living with Parkinson�s 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. Over time symptoms progress and can be unpredictable, imposing a significant impact on daily life.⁵ This impact can extend to caregivers, friends and family, whose own wellbeing and quality of life can deteriorate as a result.⁸

�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:⁹

• 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 International in neurology

Kyowa Kirin International is committed to building meaningful partnerships with the wider Parkinson�s community and is working with healthcare professionals, government agencies, policymakers and patient advocacy groups to improve care and support for people living with Parkinson�s.

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 Jenner P, Mori A, Aradi S.D, et al. Istradefylline � a first generation adenosine A2A antagonist for the treatment of Parkinson�s disease. Expert Review of Neurotherapeutics 2021, doi:10.1080/14737175.2021.1880896.

² LeWitt P, Aradi S, Hauser R, et al. The challenge of developing adenosine A2A antagonists for Parkinson disease: Istradefylline, preladenant, and tozadenant. Parkinsonism Related Disord 2020;80(Supple 1):S54�S63.

³ Ministry of Health, Labour and Welfare. NOURIAST Prescribing Information. Available at http://docplayer.net/43410136-Nouriast-tablets-20-mg.html [Last accessed: July 2021].

⁴ FDA. NOURIANZ Prescribing Information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022075s000lbl.pdf [Last accessed: July 2021].

⁵ European Parkinson�s Disease Association. About Parkinson�s. Available from: https://www.epda.eu.com/about-parkinsons/what-is-parkinsons/ [Last accessed: July 2021].

⁶ GBD 2016 Parkinson�s Disease Collaborator Group. Global, regional, and national burden of Parkinson�s disease, 1990�2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018;17:939�953.

⁷ Ball N et al. Parkinson�s Disease and the Environment. Front Neurol 2019;10:1-8 [Last accessed: July 2021].

⁸ 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.

⁹ Freitas M, Hess C, Fox S. Motor complication of dopaminergic medications in Parkinson�s disease. Semin Neurol 2017;33(2):147-157.

Contacts

Contacts for Kyowa Kirin International:
Media
Sarah Evans

Email: [email protected]

Contacts for Kyowa Kirin Co., Ltd.:
Media
Hiroki Nakamura

Email: [email protected]

KKI/INT/IST/0141

Date of preparation: July 2021