Synthon today announced that it has successfully completed multiple decentralized procedures for two formulations of zoledronic acid. Regulatory approval has been obtained for zoledronic acid concentrate solution for infusion (4 mg / 5 ml) and zoledronic acid solution for infusion (5 mg / 100 ml) in 22 European countries.
Synthon’s products are fully generic versions of Novartis’ Aclasta® (5 mg / 100 ml) and Zometa® (4 mg / 5 ml). Aclasta® is used to treat men and post-menopausal women with osteoporosis or osteoporosis caused by treatment with steroids, and patients with Paget’s disease of the bone. Zometa® is indicated to prevent bone complications such as fractures and to reduce high calcium blood levels in adult patients due to the presence of a tumor.
EU sales for zoledronic acid for all these indications amount to EUR 408 million, based on IMS Midas data 2011.
Product launch is scheduled for later this year.
Synthon, with headquarters in Nijmegen, the Netherlands is an international fast-growing pharmaceutical company and a leader in the field of generic medicines. Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of auto-immune disease, multiple sclerosis and oncology. Our products are currently approved by regulatory agencies in over 80 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,400 staff at 11 sites worldwide, and in 2011 it recorded a turnover of EUR 260 million. For more information, go to www.synthon.com.