SciClone Pharmaceuticals Expands Portfolio by Licensing Ondansetron RapidFilmTM for Chinese Market |
 |
 |
| Monday, 27 July 2009 15:47 |
|
"As access to quality healthcare and cancer therapies expands in China, the market for novel anti-emetic pharmaceuticals is growing rapidly," said Friedhelm Blobel, PhD, President and Chief Executive Officer of SciClone Pharmaceuticals. "Meeting this growing need with a potentially best-in-class formulation makes ondansetron RapidFilm a natural fit for SciClone's portfolio and underscores our commitment to expanding our presence in the Chinese healthcare market." Paolo Galfetti, CEO of APR, stated, "SciClone's more than 175-strong sales organization in China uniquely positions the company to introduce our ondansetron thin film product to that market. We are excited to be entering into this relationship with SciClone and anticipate a successful product launch and commercialization effort." Specific terms were not disclosed, but the agreement is for a ten-year period following regulatory approval, and calls for an upfront payment of $1 million and milestone payments in line with similar transactions of this kind. Based on a European formatted dossier and results from a bio-equivalency study of ondansetron RapidFilm, SciClone plans to file for product registration with the State Food and Drug Administration of China in 2010 once the European approval of the product is obtained. SciClone believes it will obtain regulatory approval in 2011 at which time it expects to introduce the product through its existing sales organization. Ondansetron RapidFilm, developed in a joint venture between APR and its German partner LabTec GmbH ("LabTec"), is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist. Ondansetron 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. The RapidFilm 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 RapidFilm 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. About SciClone SciClone Pharmaceuticals ( BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section Add this page to your favorite Social Bookmarking websites            |
FOSTER CITY, CA and BALERNA, SWITZERLAND--SciClone Pharmaceuticals, Inc. (
Free Phone Trade Alerts
