August 28, 2014BTG and SciClone Announce that DC Bead® has been approved by China Food and Drug Administration
London, UK, 28 August 2014
BTG plc (LSE: BTG), the specialist healthcare company, and its partner SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN), a China-focused specialty pharmaceutical company, today announce that the China Food and Drug Administration has approved the registration of DC Bead® for the embolisation of malignant hypervascularised tumours.
BTG and SciClone previously entered into an agreement granting SciClone exclusive licensing and distribution rights to DC Bead® in China. Under the agreement, SciClone will purchase product from BTG at a specified price for sale in China. Commercial launch plans are now underway.
Louise Makin, Chief Executive Officer at BTG, said: “Approximately half of the world’s liver cancer patients are in China and there is a great interest among Chinese physicians to offer new, differentiated treatment options. Today’s news marks an important step toward bringing our first interventional oncology product, DC Bead®, to the Chinese market where we can help address this need.”
Friedhelm Blobel, SciClone Chief Executive Officer commented: “Together with our partner BTG, we will now focus our efforts on preparing for the introduction of the product in the Chinese market. Oncology is a core business focus for SciClone, and our sales team and academic marketing liaisons have established high quality relationships with the medical professionals and institutions that specialize in cancer treatment. We believe DC Bead® has the potential to be a valuable addition to SciClone’s oncology product portfolio.”
DC Bead® is a novel treatment for liver cancer which is currently approved in 40 countries worldwide, including Europe. DC Bead® is an embolic bead delivered through a minimally invasive, non-surgical procedure to block the blood flow to tumours.
DC Bead® is registered in China for the embolisation of malignant hypervascularised tumours such as hepatocellular carcinoma (“HCC”), the most common form of primary liver cancer. The majority of people with HCC have cirrhosis, usually from chronic hepatitis B or hepatitis C infection, or chronic alcoholism. Because of the country’s high incidence of hepatitis, China accounts for approximately one-half of the world’s liver cancer cases. More than 350,000 people die from primary liver cancer in China annually[i].
DC Bead® and/or all indications may not be available in all territories. DC Bead® is not currently cleared by the FDA for sale or distribution in the USA.
For further information please contact:
Chris Sampson, Director of Corporate Communications
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251178
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Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7805 354134
Ben Atwell/Simon Conway, FTI Consulting
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Wilson W. Cheung, Chief Financial Officer
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Jane Green, Investors/Media
+1 650 358 1447
BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.
SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone's proprietary lead product, ZADAXIN® (thymalfasin), is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Through its promotion business with pharmaceutical partners, SciClone markets multiple branded products in China which are therapeutically differentiated. The Company has successfully in-licensed products with the potential to become future market leaders and to drive the Company's long-term growth. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.