Galena Biopharma Enters Into Definitive Agreement to License U.S. Rights for Zuplenz(R) (ondansetron) Oral Soluble Film
-- Novel, rapidly dissolving oral PharmFilm(R) 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.
PORTLAND, Ore., July 22, 2014 (GLOBE NEWSWIRE) -- 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(R) (ondansetron) oral soluble film. The
asset was licensed from MonoSol Rx, LLC, the developer of the oral
soluble film technology, PharmFilm(R), 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(R) 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(R) 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(R). 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(R) (ondansetron) Oral Soluble Film
Zuplenz(R) (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(R) 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(R) technology to develop products which address
the unmet needs of patients. PharmFilm(R) 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(R) technology, and two FDA
approvals - Zuplenz(R), the first approved prescription oral soluble
film for the prevention of chemotherapy-induced, radiotherapy-induced,
and postoperative nausea and vomiting, and Suboxone(R) 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
[email protected]