- Novel, rapidly dissolving oral PharmFilm® enables faster
absorption, increased convenience and better compliance for
patients.
- Planned launch in multiple indications—chemotherapy-,
radiation- and post operative-induced nausea and vomiting—in early
2015.
- FDA-Approved product to be added to Galena's established
oncology commercial team.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today announced it 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.
About Zuplenz® (ondansetron) Oral Soluble
Film
Zuplenz® (ondansetron) Oral Soluble Film is approved by the U.S.
Food and Drug Administration (FDA). Zuplenz is approved 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.
Zuplenz utilizes the proprietary PharmFilm® technology as an
oral soluble film that dissolves on the tongue in under 30
seconds. This rapidly dissolving film eliminates the
burden of swallowing pills during periods of emesis and in cases of
oral irritation, therefore increasing patient adherence and
reducing emergency visits and hospitalization due to a lack of
patient compliance or the patient's inability to keep their
treatment 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.
About Chemotherapy-, Radiation- and Post
Operative-Induced Nausea and Vomiting
It is estimated that up to 90% of patients receiving
chemotherapy experience CINV and up to 80% of patients undergoing
radiotherapy will experience RINV. For patients, CINV/RINV is among
the most feared and distressing side effects, and uncontrolled or
poorly controlled CINV/RINV can cause patients to be malnourished
or dehydrated, have electrolyte imbalances, or experience physical
and mental deterioration. In extreme cases, patients may choose to
discontinue beneficial therapy because of this side effect.
Postoperative nausea and vomiting (PONV) is one of the most
commonly occurring complications as a result of anesthesia and/or
the pain medications given during surgery. PONV results in
high levels of patient discomfort and dissatisfaction, and can
result in increased recovery room time, expanded nursing care, and
potential hospital admission—all factors that may increase total
health care costs.
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.
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.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to,
statements about the timing of commercial launch of Zuplenz,
Galena's ability to successfully commercialize Zuplenz, as well as
statements about our expectations, plans and prospects. These
forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including those identified under
"Risk Factors" in Galena's Annual Report on Form 10-K for the year
ended December 31, 2013 and most recent Quarterly Reports on Form
10-Q filed with the SEC. Actual results may differ materially from
those contemplated by these forward-looking statements. Galena does
not undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this press release.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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