Business Wire

KYOWA-KIRIN

7.8.2024 09:01:31 CEST | Business Wire | Press release

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

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

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

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Visual Bank Expands “Qlean Dataset” to Support Large-Scale Japanese Speech Foundation Models1.4.2026 21:45:00 CEST | Press release

Delivering 100,000+ hours of rights-cleared Japanese audio, including regional dialects and culturally contextualized speech essential for commercial AI development. Visual Bank Inc. (CEO: Saneyuki Nagai), through its subsidiary amanaimages Inc., one of the largest digital asset providers for the marketing and advertising industry in Japan with over 40 years of history, today announced the expansion of its Qlean Dataset, a premium AI training data solution designed for developers building high-performance Japanese speech foundation models. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401752248/en/ Visual Bank Group, leveraging over 40 years of expertise through amanaimages Inc., expands Qlean Dataset, delivering high quality, rights cleared Japanese language corpora, including 100,000+ hours of commercially usable audio. A new development within the Qlean Dataset division, which focuses on providing datasets for institu

Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press release

ARK Invest, backer of OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund and Schooner Capital back new round bringing total funding to $110M Plans to scale to 40 bases in the United States, supported by seven years of operational orchestration experience, and recently expanded its global partnerships with Uber, joining Deliveroo, Just Eat and DoorDash in delivering everyday items by air. Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include

Bureau Veritas Launches an Independent AI Assessment Offering for European Enterprises, Developed in Partnership with Amazon Web Services (AWS)1.4.2026 17:45:00 CEST | Press release

Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the launch of an AI systems audit to help European enterprises assess and demonstrate their compliance with the European Union's "AI Act" regulatory requirements. This offering combines on-site audits, document analysis, and direct testing to deliver an independent maturity report. Since the EU's AI regulation came into force in 2024, companies have faced major implementation challenges. According to a recent report*, 68% of them struggle to interpret the provisions of the text, while 60% have yet to put in place the governance needed to comply. Non-compliance can cost them up to 7% of annual revenue. Bureau Veritas has developed this new audit offering to help companies identify their compliance gaps and remedy them. Bureau Veritas's new audit offering comprises a pre-audit, document review, on-site audit, and direct testing, resulting in an independent report on the client's AI maturit

Greenland Resources Signs Eight Year Off-take Agreement With SSAB to Supply High Quality Molybdenum1.4.2026 16:29:00 CEST | Press release

Greenland Resources Inc. (TSX:MOLY, FSE:M0LY) (“Greenland Resources” or the “Company”) is pleased to announce the Company has signed a binding off-take agreement with SSAB, a Nordic and US-based steel producer headquartered in Sweden. The company is a leading producer on the global market for advanced high-strength steels providing solutions to the defence, automotive, infrastructure and energy industries. A stock exchange press release from SSAB can be found on their website at www.ssab.com This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401270749/en/ The off-take agreement provides an established price floor and price ceiling and will allow SSAB to secure high quality low carbon emission ferromolybdenum extracted in Greenland and refined in Belgium. SSAB will be able to ensure a stable and responsibly sourced long term secured primary molybdenum supply with high sustainability standards and low scope 1&2 emissions from a

VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System1.4.2026 15:30:00 CEST | Press release

VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system. The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDYNE system in patients with severe tricuspid regurgitation (TR). “This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.” Significant unmet clinical needs exist in the

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