Biocompatibles International plc
Biocompatibles International plc is a leading company in the field of drug-device combination products. The Oncology Products Division conducts the marketing of Biocompatibles' approved oncology products. These include products that are used for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer and prostate cancer. Our R&D Facilities are engaged in licensing and in new product development for oncology, stroke, and diabetes and obesity. We have collaborative agreements with AstraZeneca, Bayer Healthcare Pharmaceuticals Inc. and Medtronic Inc.
See more information about Biocompatibles International plc
Biocompatibles drug-eluting bead product to be delayed till late 2010
Biocompatibles International PLC said the launch of the DC Bead drug-elating bead product in China is likely to be delayed until the second half of 2010, however, it called the delay "modest given the size of the opportunity."
DC Bead was originally planned for launch in China later this year, but the country's State Food and Drug Administration (SFDA) has asked Biocompatibles' distribution partner SciClone Pharmaceuticals Inc (Nasdaq:SCLN) to conduct a small local trial to supplement data obtained from a previous study performed in Hong Kong.
The additional data will allow the SFDA to complete its review of the regulatory application for the liver cancer treatment.
The trial is planned to commence in the current quarter and, provided the outcome is positive, Biocompatibles expects to receive regulatory approval for DC Bead in the second half of 2010. DC Bead is approved in 40 countries worldwide, including the US (as LC Bead) and Europe.
