Further Trial Data Awaited for Bonefos in the U.S.
MONTVILLE, N.J., May 11, 2005 -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR; FSE: SCH), today announced that the outcome of its New Drug Application (NDA) for Bonefos (clodronate) is dependent upon the results of the ongoing National Surgical Adjuvant Breast and Bowel Project (NSABP) B-34 study.
The decision follows a meeting with the U.S. Food and Drug Administration (FDA) in May at which the agency indicated it would not consider approving Bonefos for marketing until results from the NSABP B-34 trial are known. Final results from the B-34 trial, which completed enrollment of 3,323 women with breast cancer in March 2004, are anticipated in 2008.
Berlex submitted an NDA for the use of Bonefos in the United States as an adjuvant oral treatment for reducing the occurrence of bone metastases in Stage II/III breast cancer patients and had received an approvable letter for Bonefos from the FDA on Jan. 6, 2005.
"While we were hopeful that the existing data would be sufficient for the FDA, "said Reinhard Franzen, President and Chief Executive Officer of Berlex Laboratories, "we now look forward to the results of the NSABP B-34 trial to determine the role that Bonefos might play in the treatment of breast cancer patients."
Oral Bonefos is approved in 67 countries outside the United States largely for the treatment of tumor-induced osteolysis and hypercalcemia. So far, nearly 20 years of use and 300,000 patient-years of experience with Bonefos have been accumulated worldwide.
Berlex, Inc., is committed to developing novel diagnostics and therapeutics that address unmet medical needs.
Berlex develops and markets diagnostic imaging agents and treatments in the areas of female healthcare and oncology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous system and gastroenterology.
Posted: May 2005
- Berlex Receives Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer - January 7, 2005
- Bonefos Accepted for Filing and Granted Priority Review by FDA - September 9, 2004