Update on status of DC Bead regulatory application in China
07/08/2009
Biocompatibles International plc (LSE:BII) refers to the following statement made on 4 August 2009 by SciClone Pharmaceuticals, Inc. (Nasdaq:SCLN), the Company’s distribution partner for China. Within the report of its second quarter 2009 results, SciClone stated:
“SciClone has recently learned from SFDA regarding its regulatory application of DC Bead™, a product for the treatment of liver cancer, that in order for the agency to complete its review, SciClone must conduct a small local trial to supplement data obtained from a previous study performed in Hong Kong by Ronnie Poon, MD. If the trial, which is planned to commence this quarter, is positive, the Company 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.”
The Company had established the goal of launching the DC Bead™ in China in 2009.
Crispin Simon, Chief Executive of Biocompatibles International plc, said “While we would have liked to have secured DC Bead approval in China this year, we believe that the projected delay is modest given the size of the opportunity.”
Contacts:
Biocompatibles
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Hogarth Partnership Limited
Julian Walker / Anna Keeble
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products. The Oncology Products Division conducts the marketing of Biocompatibles’ approved oncology products, supplied from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead products which are used in more than 35 countries for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer, and other cancers; and Brachytherapy products (Radiation-Delivering Seeds) which are used in the treatment of prostate cancer. Our distribution partners include AngioDynamics Inc., Terumo Corporation and Eisai Co. Ltd.
Our R&D Facilities are engaged in licensing and in new product development, based on the company’s core drug delivery technologies. The Drug Delivery Division, in Farnham, UK is developing new products for oncology. CellMed, in Alzenau, Germany, is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; and a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca. We also have collaborative agreements with Bayer Healthcare Pharmaceuticals Inc., Medtronic Inc. and Merz Pharmaceuticals GmbH.
This news release contains forward-looking statements that reflect Biocompatibles’ current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of Biocompatibles’ research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory and commercialisation processes.
About SciClone (www.sciclone.com)
SciClone Pharmaceuticals (NASDAQ: SCLN) is a profit-driven, global biopharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and expense management. ZADAXIN (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug candidates includes thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; RP101 in a phase 2 trial for the treatment of pancreatic cancer; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; SCV-07 with a ready-to-initiate phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead in China, where the product is under regulatory review. The Company also has commercialization and distribution rights to an anti-nausea drug ondansetron RapidFilmTM in China and Vietnam, for which it is seeking regulatory approval.