Business Wire

Kyowa Kirin International and NewBridge Pharmaceuticals Enter Into Agreement to Improve Access to Medicines for Rare Disease Patients Across Middle East and North Africa

Share

Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) and a Japan-based global specialty pharmaceutical company, announced today the signing of a Promotion and Distribution Agreement with NewBridge Pharmaceuticals for the distribution of its existing rare disease portfolio across the Middle East and North Africa (MENA).

Under the terms of the agreement, NewBridge will commercialise CRYSVITA® (burosumab) for the treatment of X-Linked Hypophosphataemia (XLH) and Tumour-Induced Osteomalacia (TIO), as well as POTELIGEO® (mogamulizumab) for two subtypes of cutaneous T-cell lymphoma (CTCL), a rare non-Hodgkin’s lymphoma.

As part of the agreement, NewBridge will exclusively distribute the two products across MENA countries of Algeria, Iraq, Libya and Jordan. KKI and NewBridge also hope to collaboratively address a number of challenges facing the rare disease community in the region by supporting disease awareness, improving time to diagnosis, and improving access to innovative treatments indicated for rare and orphan diseases.

Jeremy Morgan, President of KKI, commented: “At Kyowa Kirin our purpose is to deliver life-changing medicines and make people smile. We are pleased to be entering into this agreement with NewBridge Pharmaceuticals who have a clear mission to transform the lives of MENA patients and their families. With a commitment to delivering life changing value for people impacted by under-diagnosed and under-served diseases, this agreement is key to ensuring patients living with XLH, TIO and CTCL are able to access the medicines they need, and is another positive step on our journey.”

"Given the high prevalence of rare diseases in the MENA region, I am personally inspired and proud that we at NewBridge are building on our existing partnership with Kyowa Kirin with the addition of their rare disease products to our region,” added Joe Henein, President & CEO of NewBridge Pharmaceuticals. “This collaboration totally aligns with our mission to provide access to new therapies for patients, aiming to alleviate their suffering and enhancing their quality of life."

About CRYSVITA (burosumab)

CRYSVITA (burosumab) is a recombinant human monoclonal antibody (mAb) that binds to the protein fibroblast growth factor 23 (FGF23). This has the impact of inhibiting the action of FGF23, allowing phosphate regulation in the body to be restored.1

About POTELIGEO (mogamulizumab)

Mogamulizumab is a first-in-class humanised mAb directed against CC chemokine receptor 4 (CCR4), a protein consistently expressed in both mycosis fungoides and Sézary syndrome2–4 once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.5

About Kyowa Kirin

Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions—Japan, Asia Pacific, North America, and EMEA/International.

You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com

About NewBridge Pharmaceuticals

NewBridge Pharmaceuticals is a regional specialty company with a comprehensive pharmaceutical platform of services and expertise, established to bridge the access gap and partner with global pharma and biotech companies to in-license and commercialise innovative therapeutics that address unmet medical needs into the Middle East and North Africa (MENA) regions.

For more information, please visit www.nbpharma.com

References

1Electronic Medicines Compendium. Crysvita 10 mg solution for injection. Available from: https://www.medicines.org.uk/emc/product/9779/smpc#gref. Last accessed: November 2023.
2Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405–10.
3Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood. 2002;99(5):1505–11.
4Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res. 2003;9:3625–34.
5Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171–174.

KKI/INT/KKI/0959
Date of preparation: July 2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20240807411936/en/

Contacts

Stacey Minton
Email: Stacey.Minton@kyowakirin.com

(c) 2024 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Vertex Announces US FDA Approval of ALYFTREK ™ , a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis20.12.2024 21:46:00 CET | Press Release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK. See below for Important Safety Information, including a Boxed Warning. “ALYFTREK is our fifth CFTR modulator to secure FDA approval and represents another significant milestone in our journey to serially innovate and to improve the lives of people living with cystic fibrosis,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “Our north star for more than 20 years has been to address the underlying cause of cystic fibrosis, treat more people with this disease, and bring more people to normal le

Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non- F508del TRIKAFTA-Responsive Variants20.12.2024 21:35:00 CET | Press Release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to TRIKAFTA based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508delCFTR mutations have been added to the TRIKAFTA label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their disease for the first time. “Since its first approval in 2019, TRIKAFTA has had a transformative impact on tens of thousands of people living with cystic fibrosis,” sai

HSBC Continental Europe Enters Into a Memorandum of Understanding Regarding Potential Sale of HSBC Assurances Vie (France) to Matmut Société d’Assurance Mutuelle20.12.2024 20:32:00 CET | Press Release

Regulatory News: HSBC Continental Europe has signed a Memorandum of Understanding (‘MOU‘) regarding the potential sale of its French life insurance business, HSBC Assurances Vie (France), to Matmut Société d’Assurance Mutuelle (‘Matmut’) (the “Potential Transaction”). HSBC Assurances Vie (France) provides a wide range of life insurance solutions and services, with over 20 billion euros of outstanding assets, net income1 of 77 million euros and a Solvency II ratio of 287% in 2023. As part of the Potential Transaction, HSBC Continental Europe and Matmut would enter into a long-term arrangement for HSBC Global Asset Management (France) to continue to partner with HSBC Assurances Vie (France). HSBC Assurances Vie (France) will continue its existing distribution arrangements. The Potential Transaction would provide customers and employees of HSBC Insurance Life (France) with the opportunity to join one of the leading French mutual insurance groups, which is in full development, and forms pa

SBC Medical Group Co., Ltd. Sells Two Subsidiaries20.12.2024 13:00:00 CET | Press Release

On December 17, 2024, SBC Medical Group Holdings Incorporated (“SBC Medical”, or the “Company”), announced that its subsidiary, SBC Medical Group Co., Ltd. (hereinafter referred to as "SBCMG"), has decided to sell all shares of its subsidiaries, SBC Kijimadaira Resort Co., Ltd. (hereinafter referred to as "Kijimadaira") and Skynet Academy Co., Ltd. (hereinafter referred to as "SNA"), as outlined below. The decision to sell these subsidiaries was made to concentrate SBCMG's management resources on its core medical services business, in line with its strategy of prioritizing and focusing on key business areas. The subsidiaries being sold operate in the following industries: Kijimadaira: Ski resort operations SNA: Flight training operations The shares will be sold to a company wholly owned by Yoshiyuki Aikawa, the CEO of the Company. Since this transaction constitutes a related party transaction, it was deliberated and approved by the Company’s Board of Directors and Audit Committee. To e

Aarhus University: New Global Study Sheds Light on the Learning Crisis: Three Years After COVID-1920.12.2024 13:00:00 CET | Press Release

TIMSS 2023 has revealed an alarming global learning crisis exacerbated by the COVID-19 pandemic. Compared to the long term trend in progress in mathematics and science achievement has not only stalled but reversed when taking school closures into account, with the most vulnerable students facing the steepest losses. Key Findings Global Achievement Decline: A 0.11 standard deviation drop in student performance reflects the pandemic's lasting impact. Disproportionate Impact: Low performers, girls, and language minorities faced losses up to twice the average (0.22 standard deviations), deepening existing inequities. Regional Variations: Countries with prolonged school closures and limited remote learning resources experienced the steepest declines. Why This Matters School closures disrupted the education of over one billion children worldwide, with disadvantaged students suffering the most. “The widening gender gap in STEM fields is particularly troubling,” said Christian Kjeldsen, incomi

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye