Orexo provides update on reimbursement and launch preparations for Zubsolv®

Uppsala, Sweden – September 5, 2013 – Orexo announced today that the
preparations for launch of Zubsolv® (buprenorphine and naloxone) sublingual
tablets (CIII) has progressed according to plans and that Zubsolv will be
available in pharmacies across the U.S. from September 16. Zubsolv received
approval from the U.S. Food and Drug Administration (FDA) in July 2013 for the
maintenance treatment of opioid dependence, as part of a complete treatment plan
including counseling and psychosocial support.

Market access continues to be a key focus area for Orexo and negotiations with
payers are progressing as anticipated. Zubsolv will at launch be reimbursed in
more than 70% of the current market for opioid replacement therapy. Zubsolv will
be launched with list-pricing comparable to Suboxone film, but with an enhanced
patient assistance through co-pay support initiatives. Interest in Zubsolv among
the largest commercial plans is strong. For instance, a rebate agreement is
signed with CVS Caremark which allows its commercial PBM clients to qualify for
rebates if the client places Zubsolv in a preferred formulary position. Earlier
this year CVS Caremark announced that effective January 1st 2014, Suboxone Film
has been removed from the formularies for its commercial clients who participate
in the formulary drug exclusion program. For those clients, Zubsolv will be the
only single source brand drug covered. Orexo plans to provide further updates on
developments in the US reimbursement landscape for Zubsolv in relation to the
quarterly earnings releases.

Orexo has during the past 8 weeks finalized the establishment of the commercial
infrastructure for launch of Zubsolv in the United States. The supply chain has
inventory to meet market demands, and Zubsolv tablets will at launch be
available through all leading wholesalers and in more than 11.000 pharmacies.
Zubsolv is exclusively being supplied in specially designed child-resistant
packages, in which the individual tablets are wrapped in a special blister foil
that optimally protect children against accidental exposure. Zubsolv will at
launch be the only buprenorphine containing product, which is commercialized
with the highest degree of child resistant packaging protection (F1-grade).

The previously announced US commercial partnership with Publicis Touchpoint
Solutions is fully operational and the commercial organization has been staffed
with highly competent and talented people. The sales teams have been operational
in the most important districts since early August and the sales representatives
have engaged with many key prescribers prior to launch of Zubsolv. The
prescribers recognize the need for access to additional choices of treatment,
and the feedback obtained indicates a high unprompted awareness of both Zubsolv
and Orexo. To their support, Orexo has launched a patient support program
(www.rise-us.com), a Zubsolv home page (www.zubsolv.com) and a toll free number
1-888-ZUBSOLV, all developed for the US market.

“We are now entering the most exciting time in the history of Orexo. Having
worked closely with my team in the US and our partner Publicis Touchpoint
Solutions during the summer, I am confident we are headed for a successful
launch. Based on our recent study, in which 9 out of 10 participants preferred
Zubsolv versus the market leader, the strong feedback from prescribers who
explicitly demand alternatives for patients, and our improving market access
position, my confidence in that sales of Zubsolv can exceed $500M within 3 years
after launch has been strengthened. I am pleased with the progress in market
access achieved since approval of Zubsolv, and remain certain that we will have
a comprehensive and competitive market access position by the end year of this
across commercial and public payer segments” said Nikolaj Sørensen, President
and CEO.

As a result of the positive response in the US and growing interest in Orexo, a
process has been initiated to improve access for US investors to trade in the
Orexo share by establishment of a sponsored level 1 American Depositary Receipt
(ADR) program. Further details pertaining to this will be provided at a later
stage.

For further information, please contact:
Nikolaj Sørensen, President and CEO
Tel: + 46-703 50 78 88, E-mail: nikolaj.sorensen@orexo.com

About Zubsolv
Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for
the maintenance treatment of opioid dependence and should be used as part of a
comprehensive treatment plan, which includes counseling and psychosocial
support. Treatment should be initiated under the direction of physicians who are
certified under the Drug Addiction Treatment Act of 2000, and who have been
assigned a unique identification number (“X” number).

Zubsolv sublingual tablets deliver more buprenorphine to the bloodstream,
allowing patients to use a lower dose and thereby reducing the amount of
available drug for potential misuse and diversion. The naloxone component of
Zubsolv further reduces the potential for IV misuse and diversion.

Zubsolv sublingual tablet can be abused in a manner similar to other opioids,
legal or illicit. Clinical monitoring appropriate to the patient’s level of
stability is essential. Liver function should be monitored before and during
treatment. Children who take Zubsolv sublingual tablet can have severe, possibly
fatal, respiratory depression. Emergency medical care is critical. Keep Zubsolv
sublingual tablet out of the sight and reach of children. Zubsolv will be the
only opioid dependence treatment that is available in the highest level of child
resistant unit dose F1 packaging, thereby further reducing the chance of
unintended pediatric exposure.

Adverse events commonly observed with the sublingual administration of
buprenorphine/naloxone sublingual tablets during clinical trials and post
-marketing experience are headache, nausea, vomiting, hyperhidrosis,
constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral
edema.

The proprietary technology relating to Zubsolv is protected by patents and
patent applications in the U.S. and other markets worldwide. Projected expiry
dates for this IP range from 2019 to 2032.

For information about Zubsolv, please visit www.zubsolv.com

About Orexo AB
Orexo AB 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 sublingual 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’s development expertise is within
the area of reformulation technologies and especially sublingual formulations.
Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest
shareholders are Novo A/S and HealthCap.

For information about Orexo AB, please visit www.orexo.com.

Zubsolv is a new, advanced formulation of buprenorphine and naloxone, approved
for maintenance treatment of opioid dependent patients, which provides fast
dissolve time, small tablet size, a new menthol flavor and a higher
bioavailability than current marketed products.

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 09:30 am CET on September 5, 2013.