SciClone Licenses New Ondansetron Forumulation From APR For Chinese, Vietnam Markets
This article was originally published in PharmAsia News
Executive Summary
SHANGHAI - California-based SciClone Pharmaceuticals inked an agreement with Switzerland-based Applied Pharma Research to license Ondansetron Rapidflim for China and Vietnam. Under the agreement, SciClone will pay APR $1 million plus milestone payments for marketing rights for 10 years following regulatory approval, according to SciClone
|
SHANGHAI - California-based SciClone Pharmaceuticals inked an agreement with Switzerland-based Applied Pharma Research to license Ondansetron Rapidflim for China and Vietnam. Under the agreement, SciClone will pay APR $1 million plus milestone payments for marketing rights for 10 years following regulatory approval, according to SciClone. Co-developed by APR and its German partner LabTec GmbH, Ondansetron Rapidflim, is a rapidly dissolving thin-film formulation of anti-emetic ondansetron. The product is pending regulatory approvel in Europe. "A rapidly dissolving thin-film formulation of a successful drug that has been widely used to treat the common side effects of nausea and vomiting, following surgery, chemotherapy, and radiotherapy is very desirable, in our view," noted ThinkEquity analysts Jason Kolbert and Brian Skorney in a July 28 research note. "After all, no one typically wants to swallow a pill when he/she is vomiting, nor is it very effective if the person can't keep it in his/her system," the analysts said. Strativa Pharmaceuticals (a subsidiary of Par Pharmaceuticals) is also developing a thin film and oral spray version of ondansetron, according to the analysts. A bioequivalence study in Europe is ongoing, which is "comparing the RapidFilm delivery method to an already approved formulation of ondansetron," Friedhelm Blobel, SciClone's CEO told PharmAsia News. "SciClone's filing in China will be based on the decentralized approval in Europe, with approval expected in Belgium in 2010," Blobel added. "Based on a European formatted dossier and results from a bioequivalency study of Ondansetron Rapidflim, we plan to file for product registration with the State FDA in 2010 once the European approval of the product is obtained," Blobel said. SciClone expects regulatory approval and launch of the product in China in 2011. SciClone launched its sales operations in China in 1996, focusing on infectious disease, cancer and intensive care. The company set up offices in Beijing, Shanghai, Hong Kong and Guangzhou with 160 sales reps. The company has been focusing on building its distribution channels in China, and plans to reach more of China's population by expanding to tier 2 and 3 cities, according to Blobel. "Our commercial strategy in China is to strengthen our regulatory capabilities, clinical trial management and overall market intelligence, while accelerating sales growth, patient value and maintaining excellent profitability," Blobel noted. SciClone markets immunomodulator agent Zadaxin for Hepatitis B, Hepatitis C and other indications in China. The company is also developing DC Bead , a drug-eluting agent for treating liver cancer, which is currently under regulatory review with SFDA. "We do know that the clinical costs for approval in China are likely modest, and we do believe that there is generic competition from traditional oral formulations. With that said, SciClone has demonstrated its ability to market a brand product, Zadaxin, at a premium, and win business in China," said the analysts from ThinkEquity. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. SciClone estimated the China market for Serotonin 5-HT3 receptor antagonists, such as ondansetron, reached over $110 million in 2008. - Dai Jialing ([email protected]) |