SciClone Pharmaceuticals, Inc. Submits Regulatory Application For DC Bead In China
"With the filing of this regulatory application in China, we have taken an important step to broaden our product portfolio for the Chinese market and further our leadership position in this rapidly growing pharmaceutical market," said Friedhelm Blobel, Ph.D., Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We expect feedback from the SFDA within 90 days on this filing for DC Bead as an embolic agent, and concurrently we expect to initiate a clinical trial using DC Bead with doxorubicin, a specific chemotherapeutic agent to treat liver cancer, in the first half of 2007."
"We congratulate SciClone on the DC Bead regulatory submission," commented Crispin Simon, Chief Executive Officer of Biocompatibles International plc. "China is an important healthcare market and potentially the largest world market for products treating primary liver cancer."
About the DC Bead
The DC Bead is comprised of microscopic beads, which when administered by catheter into a blood vessel, block the supply of nutrients and blood to a tumor. While the blockage of the blood vessel itself can have an anti-tumor effect, chemotherapeutic agents can be added to the beads for a more targeted anti-tumor effect. This controlled delivery of an anti-tumor drug concentrates the toxic effect of the drug directly on the tumor and minimizes side effects throughout the rest of the body.
In June 2006, SciClone acquired the exclusive Chinese marketing rights from Biocompatibles International plc. (London:BII.L - News) for the DC Bead chemotherapy releasing device. The DC Bead is approved in Europe for use in the treatment of malignant hypervascularized tumors such as HCC.
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.
Liver cancer that cannot be removed through surgery is frequently treated by transarterial chemoembolization (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 the chemotherapeutic agent doxorubicin in particular is known to cause toxicity to the heart, including the risk of fatal congestive heart failure. DC Bead is designed to reduce this risk by delivering drugs directly to the tumor site.
About SciClone
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. A key part of SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products, such as the DC Bead, to broaden its portfolio 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 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 future sales and financial results, and 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. In addition, any statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are 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 changes in demand for ZADAXIN or DC Bead, the progress or failure of clinical trials, our actual experience in executing on our objectives, the performance of our partners, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during our clinical trials, our future cash requirements, delays in analyzing and synthesizing data obtained from clinical trials, future actions of our strategic partners, unexpected delays in preparation for enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and, with respect to DC Bead, in China, and the fact that experimental data and clinical results derived from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Contact:
Corporate contact: Richard Waldron Chief Financial Officer SciClone Pharmaceuticals, Inc. 650-358-3437
Source: SciClone Pharmaceuticals, Inc.