BEDMINSTER, N.J., April 27, 2023 /CNW/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a top 50 global specialty pharmaceutical company, today assumes primary commercial leadership for PrCRYSVITA™ (burosumab injection) in the United States and Canada from Ultragenyx Pharmaceutical, Inc., a transition planned for from the start of their decade-long collaboration. Initially discovered and developed by Kyowa Kirin, CRYSVITA is used for the treatment of X-linked hypophosphataemia (XLH) in adult and pediatric patients 6 months of age and older and for the treatment of FGF23-related hypophosphataemia in tumor-induced osteomalacia (TIO) associated with tumors that cannot be curatively resected or localized in adult patients. The transition builds on the company's existing commercial portfolio and commitment to address the needs of people living with rare diseases.
"Our collaboration with Ultragenyx has been a great success for children and adults living with XLH and TIO. Their contributions were instrumental in expediting late-stage trials, securing regulatory approval, and delivering treatment to thousands of patients," said Steve Schaefer, President, Kyowa Kirin North America. "Kyowa Kirin intends to build on the successful launch and broad access that's been established for CRYSVITA, as well as the learnings we have from working alongside XLH and TIO communities around the world, to bring more research, education, and support to patients in North America."
About the Partnership
Kyowa Kirin entered into a collaboration agreement with Ultragenyx in 2013 to hasten late-stage clinical studies and delivery of CRYSVITA to patients. Ultragenyx led Phase 3 studies and took responsibility for launching the medicine in the U.S., Canada, Latin America, and Turkey, while Kyowa Kirin leveraged its global footprint and capabilities to launch CRYSVITA across Europe, Asia, Australia, and the Middle East in addition to global manufacturing and distribution.
As part of the agreement, primary commercial responsibility for CRYSVITA in the U.S. and Canada would revert to Kyowa Kirin five years after first commercial use. During this time, the company experienced significant growth in North America, making significant investments in talent, technology, and infrastructure to support its rare disease business and services for patients, including the creation of Kyowa Kirin Cares, first created to support the company's oncology franchise, its comprehensive patient support program. Starting April 27, 2023, all support services for CRYSVITA patients and caregivers in Canada will be provided through this program.
In addition to leading commercial efforts in Latin America and Turkey, Ultragenyx will continue to work with Kyowa Kirin for the next 12 months, providing support for some commercial activities in North America.
About XLH and TIO
X-linked hypophosphataemia is a rare, lifelong, genetic disease that can impact the bones and muscles in both children and adults. Tumor-induced osteomalacia is an extremely rare, difficult-to-diagnose disease caused by slow-growing tumors that occur throughout the body.
In XLH and TIO, the body doesn't hold on to enough phosphorus, which is an essential mineral for bone health. This is due to the production of excess fibroblast growth factor 23 (FGF23), causing the body to release too much phosphorus through the urine. When phosphorus levels are too low (hypophosphataemia), it can cause the softening and weakening of growing bones in children (rickets) and mature bones in adults (osteomalacia).
In children, XLH typically appears as bowed legs or knock knees. Over time, bone weakening can also lead to bone abnormalities in the legs, delayed growth, and short stature. In adults, XLH may cause osteomalacia, fractures and pseudo-fractures, and hypophosphataemia. Patients with TIO may develop multiple bone abnormalities and can experience symptoms including severe hypophosphataemia, osteomalacia, and fractures. Symptoms are progressive and can lead to long-term disabilities, so it is vital that TIO be treated as soon as possible.
About CRYSVITA
CRYSVITA is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, that binds to and inhibits the biological activity of FGF23. By blocking FGF23, CRYSVITA helps to restore phosphate reabsorption in the kidney and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium.
Canada CRYSVITA Indication
CRYSVITA (burosumab Injection) is indicated for the treatment of X-linked hypophosphataemia (XLH) in adult and pediatric patients 6 months of age and older and for the treatment of FGF23-related hypophosphataemia in tumor-induced osteomalacia (TIO) associated with tumors that cannot be curatively resected or localized in adult patients. Treatment should be initiated and monitored by a health professional experienced in the management of patients with metabolic bone diseases.
Please consult the product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical department by calling 1-833-388-5872.
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 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 Kyowa Kirin North America at: https://kkna.kyowakirin.com/.
SOURCE Kyowa Kirin
Kyowa Kirin North America, Inc., Lauren Walrath, Vice President, Public Affairs - North America, Phone: +1 375-2309, Email: [email protected]
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