Synthon announced today that it has successfully concluded multiple registration procedures for two dosage forms of ibandronic acid (ibandronate). Regulatory clearance has been obtained for ibandronate concentrate for solution for infusion (2mg and 6mg, vials) and solution for injection (3mg, pre-filled syringes) in 16 European countries.
Synthon's products are a fully generic version of Roche’s Bondronat® (2mg and 6mg) and Bonviva® / Bondenza® (3mg). Bondronat® is indicated for the prevention of skeletal events in patients with breast cancer and bone metastases and treatment of tumor-induced hypercalcaemia with or without metastases. Bonviva® / Bondenza® are indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
With this regulatory clearance, Synthon is further complementing its ibandronate product line of tablets - launched in June 2011 - and demonstrating its transition into a specialty pharmaceuticals company, with oncology as one of the key therapeutic areas. The company has a promising pipeline of research projects and pending regulatory applications across its technological platforms of small-molecule generics, biosimilars and new biological entities.
European sales of ibandronate for both the oncology and osteoporosis indications exceed EUR 330 million.
* Bondronat®, Bonviva® and Bondenza® are registered trademarks of F. Hoffmann-La Roche AG
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 Multiple Sclerosis and oncology. Synthon employs about 1,400 staff at 11 sites worldwide, and in 2010 it recorded a turnover of EUR 230 million. For more information, go to www.synthon.com.