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news.US-based biopharmaceutical firm Galena Biopharma has entered into a definitive agreement to license the US rights for Zuplenz (ondansetron) oral soluble film (OSF), from MonoSol Rx, the developer of the oral soluble film technology, PharmFilm, and manufacturer of the product.
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In 2010, the US Food and Drug Administration (FDA) had approved Zuplenz for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV).
The drug is also approved in pediatric patients for moderately emetogenic CINV.
The company said that nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation.
Ondansetron, which is the active pharmaceutical ingredient in Zuplenz, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.
The licensing agreement includes an undisclosed upfront payment from Galena, as well as double digit royalty payments from sales of the product.
MonoSol Rx co-president and chief operating officer Keith Kendall said partnering with Galena Biopharma to provide Zuplenz to patients in need further reinforces the company’s position as a leader in the oral soluble film pharmaceutical market.
"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," Kendall said.
"With the increased availability of Zuplenz, clinicians will be able to improve the level of care they provide by utilizing our innovative drug delivery technology to eliminate swallowing issues and discomfort associated with chemotherapy, radiotherapy, and surgery."
Galena Biopharma president and chief executive officer Mark Ahn said: "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.
"Providing patients with an alternative solution for nausea and vomiting has long been a concept that oncologists and the general surgeon and oncology nurse communities have sought, and that we are eager to deploy."