Orexo receives MGBP 5 milestone payment for Abstral® in Europe and records OX-MPI non-cash impairment charge of MSEK 62
Uppsala, Sweden – December 11, 2015 – Orexo AB (publ) today announced that the
annual sales of Abstral in Europe has passed MEUR 67.5 during 2015, which
triggers a milestone payment of MGBP 5 (approx. MSEK 63.8) to Orexo AB (”Orexo”)
from the commercial partner in Europe ProStrakan Group plc (”ProStrakan”).
According to the agreement from June 2012, with ProStrakan for Abstral sales in
Europe, Orexo receives a fixed and non-conditional royalty of MGBP 55, a
variable royalty for annual sales exceeding MEUR 42.5 and milestone payments of
up to MGBP 10. With the announced MGBP 5 milestone payment Orexo has earned all
milestone payments associated with the ProStrakan European agreement.
Orexo has further decided to record a non-cash charge of MSEK 62 related to an
impairment of the OX-MPI asset. Orexo still considers OX-MPI an attractive asset
and will continue the dialogue with potential partners, however as part of the
annual impairment assessment it has been decided to fully write down the value
of the asset.
Both events will have full financial impact in the fourth quarter of 2015.
”I am pleased to follow the continued success of our commercial partner
ProStrakan with Abstral in Europe. The performance of Abstral in Europe is a
strong evidence of the patient and physician preference of the attributes of
Orexo’s sublingual products and this performance enables Orexo to continue
investing in the commercialization of Zubsolv® and in development of potential
new formulation platforms,” said Nikolaj Sørensen, CEO and President of Orexo
For further information, please contact:
Nikolaj Sørensen, CEO and President
Tel: +46 (0)703-50 78 88, E-mail: email@example.com
Henrik Juuel, CFO and EVP
Tel: +46 (0)722-20 94 77, E-mail: firstname.lastname@example.org
Abstral is the leading fast-acting fentanyl product in EU intended for treatment
of breakthrough pain in cancer patients. Abstral employs Orexo’s proprietary
sublingual delivery technology (under the tongue). After the product development
Abstral was out-licensed to Kyowa Hakko Kirin Co., Ltd. and the European
subsidiary ProStrakan Group plc, which still holds the rights in the Japan and
EU respectively, whereas Sentynl Therapeutics Inc. holds the rights in the US.
The project aims to develop products based on specific inhibition of
prostaglandin E2 (PGE2) in different disease conditions. Boehringer Ingelheim
was since 2005 responsible for all research and development within the OX-MPI
project. On August 6, 2014, Orexo announced that Boehringer Ingelheim had
decided to return the project to Orexo. The project, and the intangible asset of
MSEK 62, originates from the acquisition of Biolipox.
ZUBSOLV (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for
the treatment of opioid dependence and should be used as part of a comprehensive
treatment plan, which includes counseling and psychosocial support.
To read more about Zubsolv, visit www.zubsolv.com
To read more about opioid dependence, visit www.outthemonster.com
Orexo is a specialty pharmaceutical company commercializing its proprietary
product Zubsolv for treatment of opioid dependence in the US. Zubsolv is an
advanced formulation of buprenorphine and naloxone using Orexo’s unique
knowledge and expertise in sublingual drug delivery. R&D is focusing on
reformulation of known substances to new improved products that meet great unmet
medical needs by using its patented proprietary technologies. Orexo’s share is
listed on Nasdaq Stockholm Mid Cap (STO:ORX) and is available as ADRs on OTCQX
(ORXOY) in the US. Orexo’s global headquarters and R&D are based in Uppsala,
Orexo AB (publ) discloses the information provided herein pursuant to the
Financial Instruments Trading Act. The information was submitted for publication
at 8:00 a.m. CET on December 11, 2015.