MonoSol Rx Enters Into Exclusive Licensing Agreement With Galena Biopharma for Zuplenz(R) Oral Soluble Film

Will Use PharmFilm(R) Technology for Treatment of Chemotherapy, Radiation and Post Operative-Induced Nausea and Vomiting


WARREN, N.J., July 22, 2014 (GLOBE NEWSWIRE) -- MonoSol Rx, the developer of PharmFilm® drug delivery technology, today announced that it has licensed Zuplenz® (ondansetron) to Galena Biopharma, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. Zuplenz is an oral soluble film (OSF) for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting.

The licensing agreement includes an undisclosed upfront payment from Galena, as well as double digit royalty payments from sales of Zuplenz. Zuplenz is the first oral soluble lingual film product approved by the U.S. Food and Drug Administration (FDA) as a prescription medication, based on MonoSol Rx's proprietary PharmFilm® technology. 

Keith J. Kendall, Co-President and Chief Operating Officer of MonoSol Rx, remarked, "Partnering with Galena Biopharma to provide Zuplenz to patients in need further reinforces MonoSol Rx'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. 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."

"We are pleased to be working with MonoSol Rx to offer Zuplenz to patients in need," said Mark J. Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. "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."

Zuplenz is a unique formulation of ondansetron using MonoSol Rx's proprietary PharmFilm® technology, co-developed with partner APR Applied Pharma Research s.a. of Switzerland. It is based on a novel and proprietary oral drug delivery technology platform and consists of a polymeric OSF containing ondansetron. Once placed in the mouth, it dissolves in a few seconds, allowing the medication to be absorbed and delivered without water.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence. For press releases and other company information, visit www.monosolrx.com.

* PharmFilm is a registered trademark of MonoSol Rx.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information, visit www.galenabiopharma.com.

About APR Applied Pharma Research

APR is an independent, international and integrated Healthcare Company headquartered in Switzerland, which focuses on three major areas: Delivering, Funding and Supporting Innovation in Healthcare. In particular, APR develops and licenses innovative, value added and patented healthcare products and proprietary drug delivery systems primarily in the oral and topical fields; APR also invests in companies or early stage innovative projects and provides a balanced mix of equity funding and/or financing together with APR's development, scientific, technical, marketing, licensing and management skills and know how; finally, APR supports biotech and pharmaceutical companies in the development of new pharmaceutical projects by providing on a contract basis added value, consultancy and R&D services under contract using a General Contractor approach. APR has entered into licensing and partnership agreements with pharmaceutical companies in over 100 countries worldwide with international sales on a worldwide basis.



            

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