Galena Biopharma Acquires Abstral(R) (fentanyl) Sublingual Tablets in U.S., a
Novel, Best-in-Class Treatment Approved for Breakthrough Cancer Pain
*Abstral® was approved in the U.S. in 2011 and is the first and only
fentanyl sublingual tablet for the management of breakthrough cancer pain
in opioid tolerant patients.
*Abstral® product launch targeted in the 4th Quarter of 2013.
*To fund the acquisition and product launch, Galena plans to enter into a
non-dilutive debt financing of up to $15 million.
LAKE OSWEGO, Ore., March 18, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc.
(Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted
oncology treatments that address major unmet medical needs to advance cancer
care, today announced it has entered into an agreement with Orexo AB (ORX.ST),
an emerging specialty pharmaceutical company based in Sweden, to acquire
Abstral® (fentanyl) Sublingual Tablets for sale and distribution in the United
Abstral is an important new treatment option for inadequately controlled
breakthrough cancer pain (BTcP) in patients who are already receiving, and who
are tolerant to, opioid therapy for their persistent baseline cancer
pain.BTcP has been shown to affect as many as 40-80 percent of cancer
patients, with reported episodes of 4 per day and a median duration of 30
minutes. The innovative Abstral formulation delivers the analgesic power of
fentanyl in a convenient and easy to use sublingual tablet, which dissolves
under the tongue within seconds. Abstral provides rapid relief of BTcP,
predictable dosing, and is convenient and easy to use.
Abstral was approved by the U.S. Food and Drug Administration (FDA) in January
2011; and, it is the transmucosal immediate-release fentanyl (TIRF) market
leader in Europe where it achieved sales of $54 million by ProStrakan/Kyowa
Hakko Kirin in 2012. It is marketed in Canada by Paladin Labs, and has been
filed for approval in Japan by Kyowa Hakko Kirin, Co. Ltd. In 2012, the U.S.
market for TIRFs was $400 million.
"The acquisition of Abstral diversifies and strengthens our pipeline,
providing Galena with an FDA approved product that will become a cornerstone
of our commercial strategy and bring revenues to the Company in 2014 to
support the development of our pipeline," said Mark J. Ahn, Ph.D., President
and Chief Executive Officer of Galena Biopharma. "Galena's launch of Abstral
will build relationships with future prescribers of NeuVax™, which is
currently in global Phase 3 clinical trials in node positive HER2 IHC 1+/2+
breast cancer patients. Medical oncologists, who manage tumor and treatment
related pain, predominantly prescribe TIRFs for advanced breast cancer and
other solid tumor patients which represent the majority of overall
Under the terms of the agreement, Galena Biopharma will pay Orexo $10 million
upfront and $5 million within the first twelve months of closing, plus low
double digit royalties and one-time milestone payments based on pre-specified
Galena has identified its commercialization management team towards a launch
in the fourth quarter of 2013.To fund the acquisition and launch of Abstral,
Galena plans to enter into a debt financing, subject to customary closing
conditions. The term loan would include a total loan amount of $15 million, to
be drawn in two tranches. Terms would include a coupon rate of approximately
7.59 percent and 4.5 percent warrant coverage.Interest-only payments would be
due monthly through April 2014, then 30 months of amortization to maturity in
2016.The actual terms of the proposed debt financing may be different.
"With Galena Biopharma, Orexo has found a very committed partner for Abstral
in the United States, who is well positioned to realize the significant
potential that exists for Abstral. I have been impressed by the competence,
experience and commitment to Abstral from the Galena Biopharma management
team," stated Nikolaj Sørensen, President and CEO of Orexo.
About Breakthrough Cancer Pain
Breakthrough cancer pain is defined as a transient exacerbation of pain that
occurs either spontaneously, or in relation to a specific predictable or
unpredictable trigger, despite relatively stable and adequately controlled
background pain.Breakthrough cancer pain occurs in 40-80 percent of patients
who are already receiving chronic, long-acting opioid pain management and yet
have episodes of severe tumor- and treatment-related cancer pain.Breakthrough
pain occurs frequently in these patients, particularly as they try to conduct
normal daily activities, with a mean number of episodes of 4 per day (average
range 1-14 per day) and a median duration of 30 minutes (range 1-240 minutes).
The wide range of time to relief of these severe pain episodes leads to high
levels of distress and impaired quality of life experienced by patients.
About Abstral® (fentanyl) Sublingual Tablets
Abstral® is an important new treatment option for inadequately controlled
breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. The
innovative Abstral formulation delivers the analgesic power of fentanyl in a
convenient and easy to use sublingual tablet, which dissolves under the tongue
within seconds. Abstral provides rapid relief of BTcP, predictable dosing, and
is convenient and easy to use.
Abstral was approved by the FDA in 2011. Abstral is a sublingual (under the
tongue) fentanyl tablet indicated only for the management of breakthrough pain
in patients with cancer, 18 years of age and older, who are already receiving,
and who are tolerant to, opioid therapy for their persistent baseline cancer
pain. Abstral was evaluated in 311 opioid-tolerant cancer patients with
breakthrough pain. Of these patients, 270 were treated in multiple-dose
studies. The duration of therapy for patients in multiple-dose studies ranged
from 1-405 days with an average duration of 131 days and with 44 patients
treated for at least 12 months.
Formulated as rapidly disintegrating muco-adhesive sublingual tablets, Abstral
is highly lipophilic with the fentanyl release from the tablet almost
instantly. It is highly potent, crossing the blood-brain barrier rapidly,
avoiding first-pass metabolism by the liver enzymes, and therefore offering
high bioavailability. Moreover, the time-effect profile of Abstral closely
matches the time-intensity profile of breakthrough cancer pain episodes; and
the pharmacokinetics of Abstral have been shown to be dose-proportional over
the dose range of 100µg to 800µg.
Common adverse reactions include nausea, constipation, drowsiness and
headache. Serious adverse events, including deaths, have been reported in
patients with other immediate-release transmucosal fentanyl products and
occurred as a result of improper patient selection and/or improper dosing.
Abstral is available only through the transmucosal immediate-release fentanyl
(TIRF) Risk Evaluation and Mitigation Strategy (REMS) program, which is
intended to minimize the risk of misuse, abuse, addiction and overdose. The
FDA has standardized key components of the REMS program to facilitate the
adoption of a single shared system. These components include the REMS
document, the Patient-Prescriber Agreement, and the enrollment form.
About Orexo AB
Orexo AB is an emerging specialty pharma company developing improved
treatments using proprietary drug delivery technology. Orexo's expertise is
within the area of reformulation technologies and especially sublingual
formulations. The company has a portfolio of revenue generating EU and US
approved products currently marketed under license and a pipeline of several
reformulations of approved compounds for areas of unmet medical need. Orexo
also has collaboration projects with several international pharma companies.
Orexo AB is headquartered in Sweden has 90 employees and is listed on
NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap. For
information about Orexo please visit www.orexo.com
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing innovative, targeted oncology treatments
that address major unmet medical needs to advance cancer care.For more
information please visit us at www.galenabiopharma.com
The Galena Biopharma, Inc. logo is available at
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 Galena's expectations, plans and
prospects for commercialization of Abstral and the planned debt financing to
fund the Abstral acquisition, as well as the development of Galena's NeuVax
product candidate.These forward-looking statements are subject to a number of
risks, uncertainties and assumptions, including the possibility that Galena's
commercialization of Abstral may be delayed or prove unsuccessful, and that
the planned debt financing may not be completed on the terms indicated, or at
all.Galena's business and operations and the development of its product
candidates also are subject to the risks and uncertainties identified under
"Risk Factors" in Galena's Annual Report on Form 10-K for the year ended
December 31, 2012 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: Madeline Hatton
Toll free: +1 (855) 855-GALE (4253), ext. 109
IR Sense, LLC
+1 (503) 400-6995
Galena Biopharma, Inc.
Press spacebar to pause and continue. Press esc to stop.