Schering AG has announced that Bonefos (clodronate) has been accepted for filing and designated for priority review by the US FDA. Berlex Laboratories, Schering's US affiliate, is seeking approval for the use of Bonefos as an adjuvant oral treatment for reducing the occurrence of bone metastases in stage II/III breast cancer patients.

"We are tremendously pleased that the FDA has accepted Bonefos for priority review," said Reinhard von Roemeling, vice president Clinical Development Oncology, Schering AG Group. "This designation recognizes the significant unmet medical need facing women currently living with breast cancer," he added.

The FDA gives priority designation to products that are considered to be a potential significant therapeutic advancement over existing therapies and addresses an unmet medical need. The priority review designation provides for a six-month review from the date of filing, the company release said.

Meanwhile, Schering AG said its new dermatology company would be called "Intendis". The Intendis Group will incorporate Schering AG's world-wide dermatology business and operate its business primarily via own subsidiaries in Europe, Japan and North and South America. On June 15, 2004 Schering announced within the framework of its FOCUS initiative on the new strategic orientation of the Schering Group that it would create a separate legal entity for the company's activities in the field of dermatology.

"We are convinced that an autonomous dermatology business will give us a high degree of flexibility in creating strategic partnerships," professor Wolfgang Kehr, Head of Schering's Centre of Dermatology and designated Chairman of Intendis' Management Board said adding, "We have a number of successful products such as Finacea, Advantan and Psorcutan Beta and will systematically expand our business. Our aim is to become one of the ten largest pharmaceutical companies world-wide in the field of dermatology by 2010."

Intendis will have its headquarters in Berlin-Charlottenburg, Germany. In addition to professor Wolfgang Kehr (managing director), Dr Detlev Hessenbruch (finance and administration) has been appointed as general manager.