Healthcare Industry News: doxorubicin
News Release - June 9, 2006
SciClone Acquires Exclusive Rights in China to DC Bead Chemoembolization DeviceSAN MATEO, CA--(Healthcare Sales & Marketing Network)--Jun 9, 2006 -- SciClone Pharmaceuticals, Inc. (NasdaqNM:SCLN ) today announced that it has entered into a three year agreement with Biocompatibles International plc. (London:BII.L ) granting SciClone exclusive rights to market Biocompatibles' DC BeadTM chemotherapy releasing device within China, particularly for the minimally invasive treatment of malignant hypervascular tumors such as primary liver cancer, hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent and deadly forms of cancer in China accounting for over 300,000 deaths each year. The DC Bead is designed to be used in trans-arterial chemoembolization (TACE) procedures to embolize a tumor and deliver the chemotherapeutic agent, doxorubicin, to the tumor site in a targeted and consistent controlled-release manner. Potential advantages include increasing the exposure of the tumor to the drug and reducing drug-related toxicity by minimizing systemic exposure.
Under this agreement, Biocompatibles will manufacture the DC Bead in the U.K. and supply the product to SciClone to market in China. The agreement can be renewed three years post regulatory approval in China. A regulatory submission for approval in China is planned during 2006. The DC Bead is approved in Europe for use in the treatment of malignant hypervascularized tumors.
"The DC Bead is a natural fit for us given our sales and marketing operation's experience in the area of liver disease in China," commented Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "SciClone has successfully marketed ZADAXIN® to a targeted network of physicians and pharmacies by focusing on the 500 leading hospitals in the major metropolitan areas of China. SciClone's network of physicians includes medical thought-leaders in the fields of liver disease, cancer and intensive care and we believe that they will be keenly interested in the potential therapeutic advantages of the DC Bead."
"We are delighted with our partnership with SciClone who have the resources and credibility to tackle this important opportunity," commented Crispin Simon, Chief Executive of Biocompatibles. "We are targeting China to be a significant contributor of our sales once the DC Bead is approved. This is based on the expected growth of China's market for healthcare products in general and on the prevalence of HCC in particular."
About the DC Bead
The DC Bead is a drug delivery embolization system comprised of polyvinyl alcohol hydrogel microspheres that are loaded by the hospital pharmacy with the chemotherapy agent doxorubicin. The DC Bead combines the embolization and drug delivery to the tumor in one step. The DC Bead is administered by a catheter into the blood vessels feeding the tumor. The DC Bead is intended to block blood flow from the vessels to the tumor while releasing doxorubicin directly into the tumor site over a period of ten to fourteen days. This controlled delivery concentrates the chemotherapeutic effect of the drug directly on the tumor and minimizes systemic toxicity throughout the rest of the body.
About Primary Liver Cancer
Hepatocellular carcinoma (HCC), or primary liver cancer, is the fifth most common form of cancer worldwide, but represents the third most common cause of death from cancer. Over half of all worldwide cases of liver cancer occur in China with nearly 350,000 new cases and over 300,000 deaths each year, according to the GloboCan 2002 database (International Agency for Research on Cancer). The pervasiveness of liver cancer in China is principally due to the high prevalence of hepatitis B in that part of the world. Left untreated, hepatitis B often leads to cirrhosis of the liver and liver cancer.
The current standard of care for unresectable liver cancer is TACE. While TACE has shown efficacy in treating unresectable HCC, one of its drawbacks is the risk of systemic leakage of the chemotherapeutic drug throughout the body. The systemic exposure to doxorubicin in particular is known to cause myocardial toxicity including the risk of fatal congestive heart failure.
Biocompatibles International plc
Biocompatibles International plc is a medical technology company focused on drug device Combination Products for use in oncology and cardiology. The Company's proprietary biomedical polymer systems provide medical devices with enhanced biocompatibility and offer a platform for drug delivery. In 2002, Biocompatibles sold its cardiovascular stent division to Abbott Laboratories for £165 million and its contact lens division to The Cooper Companies, Inc. for £68 million. Further information is available at www.biocompatibles.com.
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products to market in this rapidly growing pharmaceutical market. SciClone's other drug development candidate is SCV-07, currently in early clinical development in the U.S. for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding progress and results of our clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including future actions of our collaborative partner, unexpected adverse results to patients, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and China and our ability to expand our operations, product portfolio and sales and marketing in China, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Source: SciClone Pharmaceuticals
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