Healthcare Industry News: Oral Mucositis
News Release - March 24, 2010
ondansetron RapidFilm(TM) Approved in 16 European CountriesSciClone Expects European Approvals to Support Efforts for Regulatory Approval in China, Vietnam, Hong Kong, and Macau
FOSTER CITY, CA--(HSMN NewsFeed) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN ) today announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union ("EU") countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China ("China"), Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China's rapidly growing pharmaceutical market. A key part of SciClone's strategy is to use its decade of experience in China and to grow its international business by adding commercial stage or near term commercial stage products to its portfolio.
"We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts," stated Friedhelm Blobel, Ph.D., President and Chief Executive officer of SciClone Pharmaceuticals. "The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval."
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
This novel dosage form was specifically designed to solve patient compliance problems found with existing formulations of ondansetron. Patients suffering from nausea and vomiting may have problems swallowing and difficulty retaining tablets in the gastrointestinal system long enough for tablets to dissolve fully. Ondansetron delivered in this polymeric film strip allows for fast absorption without requiring potentially nausea-worsening liquids to be introduced into the patient's system.
Serotonin 5-HT3 receptor antagonists, such as ondansetron, are the most commonly prescribed treatment for chemotherapy and radiotherapy-induced nausea and vomiting in China, where 2008 sales reached more than $110 million, according to SciClone's estimates.
SciClone Pharmaceuticals (NASDAQ:SCLN ) is a profit-focused, global specialty pharmaceutical 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 overall 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, in clinical studies as an enhancer of vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; 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; and SCV-07 in a 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 exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China, Vietnam Hong Kong, and Macau, for which it will seek regulatory approval. For additional information, please visit www.sciclone.com.
This press release contains forward-looking statements regarding development objectives and timing expectations. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "potential," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include that regulatory officials in China or Vietnam may not approve ondanestron RapidFilm for use in these countries, could impose commercial or other restrictions on SciClone's distribution of this produce or that the product could develop in the future unforeseen complications with its use. Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.
Source: SciClone Pharmaceuticals
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