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news.Shares in German research-based pharmaceutical firm Schering AG have dropped by nearly 6% after it announced that the FDA has issued an approvable letter for Bonefos, its treatment for breast cancer patients. The letter asks for more information and thus will delay the product's US approval.
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Bonefos (clodronate) is an oral non-amino bisphosphonate intended to reduce the occurrence of bone metastases in the post-surgical (adjuvant) treatment of breast cancer patients.
Berlex, Schering’s US affiliate, plans to request a meeting with the FDA to discuss the information that is needed to obtain approval, and will submit this information as quickly as possible.
Despite less than optimistic media murmurs regarding the delay, Schering remains positive about Bonefos. “We look forward to the opportunity to meet with the FDA so we can advance the approval process,” said Dr Marc Rubin, member of the Schering board of executive directors responsible for development and oncology.