MonoSol Rx Enters Into Exclusive Licensing Agreement With Galena Biopharma for Zuplenz(R) Oral Soluble Film
22 July 2014 - 9:15PM
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.
CONTACT: MonoSol Rx:
Sanford Plachter
Marketing Manager
(732) 564-5000
The Ruth Group for MonoSol Rx
Aaron Estrada (media)
(646) 536-7028
aestrada@theruthgroup.com
Lee Roth (investors)
(646) 536-7012
lroth@theruthgroup.com
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