The UK-based drug delivery company has partnered SciClone Pharmaceuticals to bring its product, an embolic bead delivered through a minimally invasive, non-surgical procedure to block the blood flow to tumours, to the Chinese market.
The approval from the CFDA this week boosts the geographical reach of DC Beads, BTG spokesman Chris Sampson told in-Pharmatechnologist.com, which the firm has flagged as a priority and source of growth.
“There will be some additional steps needed before we launch the product, notably pricing negotiation, so it may be some time before we see sales,” he said. “In the longer term, this does make us more comfortable with the growth potential of DC Bead.”
BTG specialises in products which combine drug and device in order to target how and where a medicine is delivered.
The DC Beads have been approved in this instance as a treatment that blocks blood flow to the tumour or target tissue in malignant hypervascularised tumours, while in other markets they are used to deliver chemotherapeutic drugs to tumours.
“The beads are produced from a biocompatible polyvinyl alcohol (PVA) hydrogel that has been modified with sulphonate groups that allow for the controlled loading and delivery of chemotherapeutics,” in addition to occluding the blood flow to tissue Sampson explained.
“In the UK for example, DC Bead is considered a device and is CE marked to be loaded with doxorubicin [Doxil, manufactured by Janssen] for the purpose of embolisation and delivery of a local, controlled, sustained dose of doxorubicin to the tumour,” he continued.
In other territories the beads are approved to be preloaded with Pfizer’s drug Camptosar (irinotecan) for embolisation of vessels supplying malignant colorectal cancer metastasised to the liver.
“As we come to better understand the needs and practices of the China market, we could consider supplementary filings to obtain specific approval for drug loading the beads.”
The DC Beads are manufactured from BTG’s Farnham facility in Surrey, UK.
Sale of brachytherapy business
In July 2013, the firm was hit with a US FDA warning letter at a plant in Oxford, Connecticut which made implantable brachytherapy bead devices used to treat cancer, forcing production to be put on hold.
Though a minor part of BTG’s business acquired as part of the £177m ($293m) acquisition of Biocompatibles in 2010, we asked Sampson on the latest update:
“In September of last year 2013 we sold our brachytherapy business, included the facility in Oxford, CT, to Eckert & Ziegler Group, based in Berlin, Germany,” he said. “At that time we had made significant progress in identifying and implementing remedial actions to address the issues cited by the FDA, but Eckert & Ziegler is now responsible for that work and the better source of a status update.”
However, he added BTG still maintained a small facility on the Connecticut site, responsible for processing orders and fulfilment of some Bead products, but they are not manufactured there.