SciClone Pharmaceuticals, Inc. Expands Portfolio by Licensing Ondansetron RapidFilm(TM) for Chinese Market from APR Applied Pharma Research S.A.
"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 (NASDAQ:SCLN - News) is a profit-driven, global biopharmaceutical 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 expense management. ZADAXIN 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 for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; RP101 in a phase 2 trial for the treatment of pancreatic cancer; 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; SCV-07 with a ready-to-initiate phase 2 trial for the treatment of HCV; and, awaiting approval in China, DC Bead(TM) for the treatment of liver cancer. For additional information, please visit www.sciclone.com.
About APR Applied Pharma Research S.A.
APR is a private R&D corporation headquartered in Switzerland. The core business is the development of its own selected drug candidates (developed using APR proprietary technologies) as well as the development of pharmaceutical products and medical devices under third party contract. Leveraging its technology platforms, R&D know-how, marketing and regulatory expertise, APR is committed to create sustainable value on its own as well as on third party products and projects. The APR products and technologies are licensed to third parties for distribution and marketing. R&D activities are carried out directly or under contract.
Forward-Looking Statements
This press release contains forward-looking statements regarding business 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," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," 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 our ability to obtain product registration of and commercialize ondansetron RapidFilm(TM) in China and Vietnam which may be affected by regulatory restrictions, economic conditions, competition, the performance of our partners, vendors and other third parties with which we do business, and other matters. Please also refer to other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.