Orexo sells Abstral® in the United States to Galena Biopharma, Inc.
| Source:Orexo AB
Telephone conference March 18 at 1:00pm CET
Uppsala, Sweden – March 18, 2013 – Orexo AB today announced that it sold
Abstral® (fentanyl) Sublingual Tablets in the United States to Galena Biopharma,
Inc. (NASDAQ: GALE). Under the terms of the agreement, Galena Biopharma will pay
Orexo US$10 million upfront and an additional US$5 million within the first
twelve months after signing, plus low double digit royalties and milestone
payments based on pre-specified sales levels.
Galena Biopharma is a biopharmaceutical company developing innovative, targeted
oncology treatments that address major unmet medical needs to advance cancer
care. Abstral is a novel, rapidly-disintegrating, sublingual (under the tongue)
rapid acting formulation of fentanyl, a well-established opioid, and is
indicated for the management of breakthrough pain.
Abstral is the leading rapid acting fentanyl product in Europe, where it
achieved full year sales of US$54 million in 2012, and continues to exhibit a
steady growth of 42% for Q4‑2012 over Q4-2011. By the second half of 2012, the
average volume market share of Abstral in the major European markets reached
29%. Abstral is marketed in Canada by Paladin Labs, and has been filed for
regulatory approval in Japan by Kyowa Hakko Kirin Co Ltd.
Abstral was approved by the US Food and Drug Administration in 2011. Orexo
announced in June 2012 the acquisition of all US rights to Abstral from
ProStrakan Group plc as a part of a reconfiguration of the worldwide rights to
Abstral. With completion of the current transaction Orexo has secured net cash
payments of over SEK 700 million (US$ 110 million) and in addition milestones
and royalty payments, as a result of the worldwide reconfiguration of Abstral.
During the last five months, Orexo has evaluated the optimal path forward for
Abstral in the United States. The US market for rapid acting fentanyl products
reached US$400 million in 2012. Given the continued success that Abstral
achieves in Europe, Orexo wanted to secure a commercial team that could drive
Abstral to a similar success in the United States. To attain this, Abstral
needed to be commercialized by a dedicated partner with insight into the US
pharmaceutical market for treatment of cancer and pain. Market research has
documented a substantial unmet patient need for improved treatment of
breakthrough cancer pain across oncology centers in the United States.
“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
dedication to Abstral from the Galena Biopharma management team” stated Nikolaj
Sørensen, President and CEO of Orexo. “With an agreement in place for Abstral,
we have further strengthened our financial capacity to ensure the optimal launch
of Zubsolv in the United States, which will be the primary focus for Orexo in
“Orexo is a proven leader in developing and commercializing novel formulation
technologies, particularly sublingual formulations to enhance drug delivery and
performance," said Mark J. Ahn, Ph.D., President and Chief Executive Officer of
Galena Biopharma. "The acquisition of Abstral in the United States diversifies
and strengthens our pipeline, providing Galena with an FDA approved product that
will become the cornerstone of our commercial strategy. 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 transmucosal immediate release fentanyl
for advanced breast cancer and other solid tumor patients who represent the
majority of overall prescriptions."
Guggenheim Securities acted as exclusive financial advisor and Dechert LLP as
legal advisor to Orexo in connection with the transaction.
CEO Nikolaj Sørensen will present the background to the agreement with Galena
Biopharma at a teleconference today at 1:00pm CET. The audiocast will be
accessible live via the link below and on the website.
Telephone: +44 (0) 20 3003 2666 - Standard International Access; 020-089 6377 -
Stockholm Toll Free; 0808-109 0700 - UK Toll Free; +1 866 966 5335 - USA Toll
For further information, please contact:
Nikolaj Sørensen, President and CEO
Tel: + 46-703 50 78 88, Email: email@example.com
Abstral is the novel, rapidly-disintegrating, sublingual (under the tongue)
formulation of fentanyl, a well-established opioid used for the management of
episodes of breakthrough pain experienced by cancer patients who are already
receiving opioid analgesics for chronic pain. Abstral is approved in the EU, US
and Canadian markets.
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 licence 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 AB please visit
About Galena Biopharma
Galena Biopharma, Inc. (NASDAQ: GALE) is a Portland, Oregon-based
biopharmaceutical company that develops innovative, targeted oncology treatments
that address major unmet medical needs to advance cancer care. For more
information about Galena Biopharma Inc please visit www.galenabiopharma.com.
Orexo is required under the Financial Instruments Trading Act to make the
information in this press release public. The information was submitted for
publication at 08:00am CET on March 18, 2013.
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