Uppsala, Sweden – September 20, 2013 – Orexo AB today announced the approval of
Abstral® (fentanyl) sublingual tablets in Japan, where the product has been
registered and will be sold by Kyowa Hakko Kirin Co., Ltd. Based on the
agreement, the approval will trigger a milestone payment to Orexo.
Kyowa Hakko Kirin and its subsidiaries have the rights for Abstral in all
markets except the US, where the rights are held by Galena Biopharma, Inc. In
Japan, Abstral will be distributed jointly by Kyowa Hakko Kirin and Hisamitsu
Pharmaceutical Co., Inc. The two companies are well established in the field of
treatment of cancer pain. Kyowa Hakko Kirin and Hisamitsu Pharmaceutical are
jointly selling Fentos® Tape (fentanyl citrate transdermal absorption product)
since June 2010.
“With this approval, Abstral has now successfully been developed in the three
major pharmaceutical markets in the world. The approval in Japan demonstrates
again the capability of our organization as well as the value recognized by the
regulatory authorities from new and advanced pharmaceutical sublingual
formulations that improve treatment of patients. The approval in Japan is an
exciting opportunity for Abstral and for Orexo and we are convinced that Kyowa
Hakko Kirin is well positioned to successfully launch Abstral in Japan.” said
Nikolaj Sørensen, President and CEO of Orexo.
Abstral is the leading rapid acting fentanyl product in Europe, where it
achieved full year sales of EUR 41 million (US$54 million) in 2012. In the first
half of 2013, sales exceeded EUR 24 million (US$32 million) corresponding to 27%
growth period for period.
For further information, please contact:
Nikolaj Sørensen, President and CEO
Tel: +46-18-780 88 00, Email: firstname.lastname@example.org
Abstral is a 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 US, EU and
About Orexo AB
Orexo is an emerging specialty pharma company with commercial operations in the
United States and R&D in Sweden developing improved treatments using proprietary
drug delivery technology and commercial operations in the United States. The
company is commercializing its proprietary product, Zubsolv® (buprenorphine and
naloxone), for maintenance treatment of opioid dependence, in the United States.
Zubsolv is a novel formulation of buprenorphine and naloxone using Orexo’s
extensive knowledge in sublingual technologies. Orexo has a portfolio of two
approved and revenue generating products currently marketed under license in the
EU and US. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX
and OTC market in the US (ORXOY). The largest shareholders are Novo A/S and
For information about Orexo AB, please visit www.orexo.com.
About Kyowa Hakko Kirin
Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on
its core business area of oncology, nephrology and immunology/allergy. Kyowa
Hakko Kirin leverages antibody-related leading-edge technologies to discover and
develop innovative new drugs aiming to become a global specialty pharmaceutical
company which contributes to the health and well-being of people around the
For more information, visit www.kyowa-kirin.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 09:15 am CET on September 20, 2013.
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