Galena Biopharma (GALE) Enters Licensing Agreement for Zuplenz Oral Soluable Film

Galena Biopharma (Nasdaq: GALE) has entered into a definitive agreement to license the U.S. 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 U.S. 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 (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. It is estimated that up to 90% of chemotherapy and up to 80% of radiotherapy patients will experience CINV and RINV respectively.

The active pharmaceutical ingredient in Zuplenz, 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. According to data from Wolters Kluwer, the oral 5-HT3 market exceeds $1 billion in the U.S.

Zuplenz utilizes MonoSol Rx's proprietary PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than thirty seconds. This rapidly dissolving, oral soluble film eliminates 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 the patient's inability to keep the medication down without vomiting. Zuplenz is supplied in both 4 mg and 8 mg ondansetron doses with a safety profile equivalent to other products in the class.

"We believe the innovative product benefits of Zuplenz, combined with our experienced oncology sales team, will create significant acceleration and leverage to our commercial product portfolio," said Mark J. Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. "Our commercial franchise was established last year with the acquisition of Abstral® for the treatment of breakthrough cancer pain. Adding Zuplenz to our commercial portfolio enhances our offering of supportive care products that are simple to take and provide reliable dosing to improve the quality of life for patients suffering from cancer or recovering from surgery and the associated side-effects."

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 (NDA) for Zuplenz, Galena will pay MonoSol Rx a total of $5,000,000 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 U.S. patent applications with an anticipated expiration date of 2029. Galena expects to launch Zuplenz in early 2015.

"MonoSol Rx has established our proprietary PharmFilm technology in multiple approved and pipeline products, including Zuplenz and Suboxone®. We believe Galena's established, oncology focused commercial team understands the advantages of our PharmFilm technology and can successfully commercialize Zuplenz in all three indications," concluded, A. Mark Schobel, Co-President and CEO of MonoSol Rx.

You May Also Be Interested In

• Take-Two Interactive Software (TTWO) to Cut 5% Staff, Announces Cost Reduction Plan
• Morgan Stanley CEO: investment banking momentum is building - Conference Call
• UnitedHealth (UNH) beats earnings, revenue estimates in Q1; shares up