Synthon announces European approvals for Ibandronic acid

Synthon is announcing today that it has successfully concluded multiple registration procedures for Ibandronic acid. Regulatory clearance has been obtained for Synthon's product in 25 European countries. Registration has been established for two products, Ibandronic acid 50 mg tablets and Ibandronic acid 150 mg tablets.

Synthon's products are a fully generic and bioequivalent version of Bondronat® 50 mg and Bonviva® 150 mg tablets. The product contains the active ingredient sodium ibandronate.

Bondronat® is indicated for the prevention of skeletal events in patients with breast cancer and bone metastases. Bonviva® is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

European sales of Ibandronic acid in 2009 were 358 million Euros based on IMS Midas data.

About Synthon:

Synthon’s Ibandronate forms part of a rich pipeline of research projects and pending regulatory applications.

Synthon is a privately held specialty pharma company. With facilities in nine different countries, the company is dedicated to research, development, production, licensing and marketing of high quality alternatives to innovative medicines.

Bonviva® and Bondronat® are trademarks of Hoffmann-La Roche AG.

For more information please contact PR@synthon.com.