New Indication for Teijin Pharma’s Febuxostat in Europe
Tokyo, Japan, June 30, 2015 --- Teijin Pharma Limited, the core company of the Teijin Group’s medical and pharmaceutical business, announced today, the Menarini Group, a sublicensee of its European partner Ipsen, has received approval in Europe for an expanded indication for ADENURIC (febuxostat), a novel drug for the treatment of hyperuricemia and gout. The indication is prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (TLS).
The expanded indication is based on positive results achieved in a phase 3 clinical trial involving 346 patients exhibiting intermediate to high risk of TLS. The trial proved that febuxostat has important clinical significance and high potential for treatment compared to existing options. As a result, the Menarini Group has been allowed to extend its marketing protection period for an additional year, until April 20, 2019.
In the meantime, Teijin Pharma is conducting a phase 3 clinical trial of febuxostat for hyperuricemia associated with a malignant tumor receiving chemotherapy.
TLS is a generic term for symptoms caused by large quantities of nucleic acids, phosphate and potassium in malignant tumor cells that are released into the blood due to the administration or radiation of anticancer agents. Nucleic acids are degraded and metabolized into uric acid. When large quantities of uric acid are produced in the human body due to TLS, the result can be hyperuricemia or acute renal failure, which sometimes leads to a critical and possibly fatal outcome.
In Europe allopurinol is used for prevention of TLS-associated hyperuricemia as the standard of care, which is also used for hyperuricemia associated with gout. The only alternative option, rasburicase, a uric acid-degrading enzyme, is used in Europe mainly in the case of patients with high-risk of TLS. Under these conditions, new treatment options have been in demand.
Going forward, Teijin Pharma aims to continue contributing to enhanced antihyperuricemic treatments and the improved quality of life for gout patients.
About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of sustainable transportation, information and electronics, safety and protection, environment and energy, and healthcare. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 150 companies and around 16,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY786.2 billion (USD 6.6 billion) and total assets of JPY 823.7 billion (USD 6.9 billion) in the fiscal year ending March 31, 2015.
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