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

Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release

A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us

Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release

Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas

ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release

OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future

Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release

Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority

Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release

Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s

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