Access to Medicines
Kyowa Kirin Group Policy for Access to Medicines
We at the Kyowa Kirin Group seek to fulfill our management philosophy, “The Kyowa Kirin Group companies strive to contribute to the health and wellbeing of people around the world by creating new value through the pursuit of advances in life sciences and technologies.”
The Kyowa Kirin Group, as a global specialty pharmaceutical company originating from Japan and committed to continuously creating life-changing value that ultimately makes people smile, believes that improving access to medicines is an important social issue related to health and well-being.
The Kyowa Kirin Group believe that it is our mission to deliver medicines to as many patients as possible and as quickly as possible, and we will promote initiatives from three perspectives of "providing medicines that meet unmet medical needs," "improving access to medicines," and "Quality Assurance and Stable Supply and Ensuring Patient Safety and Appropriate Use of Medicines" by clarifying the necessary functions for each initiative, appointing managers to oversee each function, and promoting close cooperation among the functions as well as collaboration with external stakeholders.
This group policy applies to all employees of the Kyowa Kirin Group. We will also encourage all of our partners in the supply chain to act in the spirit of this policy.
Provide pharmaceuticals for Unmet Medical Needs
- Promotion of research and development for the creation of groundbreaking drugs
The Kyowa Kirin Group has been working to create new drugs for diseases for which there are no effective treatments, including rare diseases, by focusing on their pathological mechanisms. The Kyowa Kirin Group will continue to take on the challenge of advancing our antibody technology, as well as making full use of even more diverse modalities in our drug discovery efforts, leveraging Kyowa Kirin's strengths. We will also be utilizing open innovation to accelerate this R&D effort. The Kyowa Kirin Group believes that the most important factor in improving access to medicines is to provide patients with the medicines produced in this way.
Improving access to medicines
- Access to unapproved drugs
For patients with serious or life-threatening symptoms for whom no other effective treatment is available, the Kyowa Kirin Group will appropriately consider how to provide the investigational drug in accordance with the regulations of each country if the physician judges that the expected efficacy of the investigational drug outweighs the safety risks to the patient, even when the patient does not meet the criteria for participation in a clinical trial.
- Intellectual property
Research and development are the business foundation of the Kyowa Kirin Group, and intellectual property is an important business asset for us. In countries with unique economic constraints, however, consideration will be given to patent applications and enforcement of patent rights.
- Disease awareness
The Kyowa Kirin Group will work globally with medical professionals, academic institutions, patient groups, and others to promote disease awareness and patient advocacy activities in accordance with country regulations, with the objective of improving understanding of the disease.
- Patient support
If safe use of quality-assured products is possible, the Kyowa Kirin Group will work to improve access to medicines through a variety of initiatives in accordance with national regulations, including programs to help patients who have difficulty obtaining medicines.
Quality Assurance and Stable Supply and Ensuring Patient Safety and Appropriate Use of Medicines
The Kyowa Kirin Group strives to ensure a stable supply through efficient global supply chain management, product quality assurance, and ensuring patient safety and appropriate use of medicines so that patients around the world can continue to use our products with peace of mind, and we deliver necessary medicines and related information to patients in an appropriate timing.
Provide Pharmaceuticals for Unmet Medical Needs
Kyowa Kirin has been working to create new medicines for diseases for which there are no effective treatments by focusing on their pathological mechanisms. We will continue to take on the challenge of advancing our antibody technology, as well as making full use of multiple modalities in our drug discovery.
Globally, by providing three pharmaceutical products - Crysvita®, Poteligeo® and Nouriast®/Nourianz®, we are working to deliver value and smiles for those who are facing diseases. Based on our Group Policy for Access to Medicines established in 2022, we are striving to improve access to our medicines across the value chain for delivering our life-changing value to patients who need them, while also realizing our growth as a Global Specialty Pharmaceutical Company.
Also, from the perspective of providing medicines that satisfy unmet medical needs, we have been working to create medicines for rare diseases for which there are no effective treatments currently.
Please see below for information on our medicines designated as orphan drug in Japan.
Improving access to medicines
Kyowa Kirin publishes "Cutaneous T-cell lymphoma (CTCL) Patient Experiences Report"
Kyowa Kirin International PLC has published "Cutaneous T-cell lymphoma (CTCL) Patient Experiences Report" which highlights the experiences of three individuals diagnosed with CTCL. Kyowa Kirin Group is deeply committed to working with patient communities to drive awareness, give patients a voice and empower those affected by rare diseases. Through this report, Kyowa Kirin International PLC demonstrates how CTCL affects the everyday lives of people who live with this condition.
In this report, Al from Norway, Ellie from the UK and Frederic from France who all live with CTCL, share their stories of life with this rare cancer. They explain the very real and significant impact the disease has had on their day-to-day life.
Whilst each individual’s story is unique, there are parallels across all three and through continued collaboration, opening up dialogues and advancing innovative science and technology, we want to bring hope for these patients worldwide, whose voices are not always heard.
All of Kyowa Kirin is grateful to Al, Ellie and Frederic who have shared their stories, in the hope of helping others in a similar situation and would also like to thank Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation for writing the foreword to the report.
White Paper on the unrecognized burden of XLH in adults in Europe
A White Paper "The unrecognized burden of XLH in adults – A call for action (480KB)" that aims to identify the unmet needs of adults living with the disease in Europe have been published in collaboration with medical experts and patient communities.
X-linked hypophosphatemia (XLH) is a genetic form of rickets causing debilitating abnormalities in the bones, muscles and joints. The disease has historically been considered a childhood disease, but the white paper seeks to provide a greater understanding of the challenges faced by adults with XLH and highlight what is needed in society to support people living with the condition throughout their life.
The study was conducted by Kyowa Kirin International PLC and expert authors Pol Harvengt (RVRH-XLH, French member association of the International XLH Alliance), Dr Lothar Seefried (Orthopedic Institute, König-Ludwig Haus, Würzburg, Germany), Dr Michael Smyth (Pharmaceutical physician and former employee of Kyowa Kirin International, Galashiels, UK) and Dr Richard Keen (Royal National Orthopaedic Hospital, Stanmore, UK).
Findings show that XLH causes severe pain, musculoskeletal deficits and mobility issues in adulthood with life-long psychosocial impacts, affecting not only the individual, but also their family, society and the healthcare system. In a survey amongst XLH patient associations, continued access to treatment in adulthood was ranked as one of the top priority unmet needs, as well as improving awareness among healthcare professionals of the need for ongoing specialist care.Furthermore, there is a strong need to recognise XLH as a lifelong disease and ensure integrated, high-quality care at all life stages, and to strengthen EU-level collaboration to address the inequality of disease burden and management across Europe.
Kyowa Kirin is grateful for the vital insights, support and counsel provided by the expert authors, the XLH Alliance Network, as well as to those adults involved with XLH and their clinicians. This is a great example of critical collaboration between medical and patient communities to develop a White Paper that make an important contribution to the medical literature. Our special gratitude goes to Oliver Gardiner (Chair of XLH UK and Co-Chair of the International XLH Alliance) and Tia Haverinen (Board member of Finnish Kalfos Ry) for their contributions.
Kyowa Kirin launched Rare Bones Framework in UK
Over the past few years, progress has been made to improve the standard of care for rare bone conditions; however, adults living with these conditions still face several challenges when accessing care.
In the UK, Kyowa Kirin brought together clinicians and patient representatives specialising in rare bone conditions to identify these care challenges and make recommendations on potential solutions to help improve care and promote a holistic approach to support people with these conditions. Following this initial discussion, a smaller steering committee was convened to develop the Proposed framework on a networked service model for care of adults living with rare bone conditions in England. On 16 May 2022, a broader group of clinicians, people living with rare diseases and patient groups also commented on the framework. Their contribution are factored into the final version of the document (available here along with an executive summary).
Its development was led and fully funded by Kyowa Kirin, with writing support from Evoke Incisive Health. The steering committee had full editorial control of its content and received no payment for their contribution and insights.
Kyowa Kirin is grateful for the rare diseases community’s support in developing this framework. We are keen to support clinicians, people with rare conditions and their representatives, as appropriate, to make it a reality in England and beyond.
Quality Assurance and Stable Supply, and Ensuring Patient Safety and Appropriate Use of Medicines
For related initiatives, please see the following pages.
Other related initiatives
Participating in the Global Health Innovative Technology Fund (GHIT Fund)
Since 2016, Kyowa Kirin has been participating in the GHIT Fund, a public-private partnership for promoting discovery of new drugs for infectious diseases in developing countries.
A public-private partnership jointly funded by the Government of Japan, Japan’s leading life science companies, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the UN Development Programme (UNDP), the GHIT Fund is the world’s first of its kind to exclusively tackle product development in the global health field.
By endorsing the GHIT Fund’s objective of establishment and activities and by supporting its activities to deliver new drugs to patients with currently untreatable diseases, We aims at contributing to the enhancement of global health.
Efforts to Reduce the Medical Costs Burden of Biopharmaceuticals
As public health spending increase, curbing them has become a issue in many countries.
The Kyowa Kirin Group, together with Kyowa Kirin Frontier Co., Ltd. and FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. is committed to contribute to society by responding to social demands to curb health spending and increasing opportunities for more patients to receive treatment.
For details, please visit the each company's website.