SciClone Pharmaceuticals, Inc. 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.