Galena Licenses MonoSol Rx’s Oral Thin Film Drug Zuplenz

Galena Biopharma, Inc., a biopharmaceutical company developing and commercializing targeted oncology treatments, has entered into a definitive agreement to license the US rights for the commercial product Zuplenz (ondansetron) oral soluble film. The asset was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm, and manufacturer of the product.

Zuplenz was approved in 2010 by the US Food and Drug Administration (FDA) in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting, and post-operative nausea and vomiting. Zuplenz is also approved in pediatric patients for moderately emetogenic CINV.

Ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.  

Galena has entered into an exclusive license and supply agreement with MonoSol Rx, the effectiveness of which is subject to the court approval of a settlement that MonoSol Rx has reached with a former licensee of Zuplenz.  Under the terms of the license agreement, upon effectiveness of the license and transfer to Galena of the new drug application for Zuplenz, Galena will pay MonoSol Rx a total of $5 million in cash and stock. The license agreement also provides for fixed double-digit royalties on net sales and pre-specified, one-time sales milestones. Zuplenz has issued and pending US patent applications with an anticipated expiration date of 2029. Galena expects to launch Zuplenz in early 2015.

Source: Galena BioPharma 

Leave a Reply

Your email address will not be published. Required fields are marked *