Galena Biopharma will license U.S. rights to the oral soluble film (OSF) formulation of Zuplenz® (ondansetron) for nausea and vomiting in cancer patients from its co-developer and manufacturer MonoSol Rx for more than $5 million, the companies said today.

The licensing agreement comes less than a year before the oral film formulation’s scheduled launch early next year. As with the existing Zuplenz tablet, the new Zuplenz OSF will be indicated for the prevention of chemotherapy-induced, radiation-induced and post-operative nausea and vomiting treatment.

A serotonin 5-HT3 receptor antagonist that works by blocking the action of serotonin, Zuplenz was approved in adults by the FDA in 2010 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—also indicated for children for moderately emetogenic CINV—is supplied in both 4 mg and 8 mg ondansetron doses, with a safety profile equivalent to other products in the class.

Zuplenz OSF uses MonoSol Rx’ PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than 30 seconds, allowing for its use without water. Co-developed with APR Applied Pharma Research, the OSF consists of a polymeric OSF containing ondansetron.

The oral soluble film is designed to eliminate the burden of swallowing pills during periods of emesis and in cases of oral irritation, therefore increasing patient adherence and reducing emergency room visits and hospitalization due to a lack of patient compliance or patient inability to keep the medication down without vomiting.

Galena agreed to pay MonoSol Rx an undisclosed upfront payment, as well as $5 million in cash and stock, and fixed double-digit royalties on net sales and pre-specified, one-time sales milestones.

“MonoSol Rx's oral film delivery technology represents a substantive advancement in terms of ease of use and compliance for supportive care patients, where difficulty swallowing can be a major issue,” Mark J. Ahn, Ph.D., Galena’s president and CEO.

Added Keith J. Kendall, MonoSol Rx’ co-president and COO: “Through this partnership, we hope to empower supportive care providers with a more comfortable, easier-to-use formulation of ondansetron that addresses a significant unmet medical need, particularly among cancer patients.”

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