U.S. FDA Approves ZUBSOLV® for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence

Uppsala, Sweden – August 11, 2015 - Orexo AB (publ) announced today that the
U.S. Food and Drug Administration (FDA) has approved ZUBSOLV®
(buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine
maintenance therapy in patients with opioid dependence. The approval expands on
the current indication for ZUBSOLV, originally approved by the U.S. FDA on July
3, 2013, and is based on data from two Phase III studies demonstrating ZUBSOLV
as a an effective treatment for opioid dependence with a solid safety profile.
Induction is the initial process a physician performs when a patient is
transitioned from the opioid he or she is dependent on to Zubsolv for long term
maintenance treatment of opioid dependence.

“The FDA approval for induction treatment constitutes yet another important
milestone for ZUBSOLV and enables our field force to promote use of ZUBSOLV from
the first day of the patients’ treatment for opioid dependence,” said Nikolaj
Sørensen, CEO and President, Orexo AB. “The addition of the new induction
indication can further fuel the positive momentum in Zubsolv sales, where we
last month saw an increase in market share with 0.2 percentage point from June,
reaching 6.1 percent, the highest level since launch. This is the eighth
consecutive week with increasing market share on a four week basis since mid
-June”.

“The induction indication, along with the coordinated launch of 2.9 mg and 11.4
mg strengths later this year, further differentiates and strengthens the
competitive position of ZUBSOLV giving physicians and opioid dependent patients
the flexibility to optimize treatment from induction through stabilization,
maintenance and tapering phases”, said Robert DeLuca, President, Orexo US, Inc.

The approval of the expanded indication for ZUBSOLV was supported by combined
data from the Induction, STabilization, Adherence and Retention Trial (ISTART)
(Study OX219-006) and Study OX219-007 which showed excellent results with over
90 percent of patients treated with ZUBSOLV remaining on treatment at Day 3 and
using a formulation with a 30 percent lower dose of buprenorphine. No
significant differences were observed between the safety profiles of ZUBSOLV and
generic buprenorphine—the most common treatment-related adverse events (≥5%)
during the induction phase were nausea (Zubsolv – 3.5%; generic buprenorphine –
5.3%) and headache (Zubsolv – 5.2%; generic buprenorphine – 5.5%).

“This regulatory milestone supports ZUBSOLV as an effective induction treatment
for patients taking their first step on the pathway to recovery from opioid
dependence,” said Michael Sumner, Chief Medical Officer, Orexo. “We know more
than 40 percent of DATA 2000 waivered physicians who are less active treating
patients cite initiation of treatment as the greatest challenge. With the
induction indication, Orexo can take an active role to educate the waivered, but
not active, prescribers in initiation of treatment and improve access to
treatment for patient suffering from opioid dependence.”

For further information, please contact:
Nikolaj Sørensen, CEO and President, Orexo AB
Tel: +46 (0)703-50 78 88, E-mail: ir@orexo.com

Teleconference
Nikolaj Sørensen, CEO, and Michael Sumner, Chief Medical Officer, will also take
questions to the induction label and the business in general at a teleconference
tomorrow, Wednesday, August 12 at 1:00pm CET.
Dial-in details will be made available on the website, www.orexo.com.

About the Induction, STabilization, Adherence and Retention Trial (ISTART)
(Study OX219-006)
The ISTART Trial (n=758) was a randomized, non-inferiority, multicenter study to
assess early treatment efficacy when switching between treatments of ZUBSOLV in
comparison to generic buprenorphine monotherapy for induction and Suboxone®Film
of opioid maintenance therapy. The primary endpoints were retention in treatment
at Day 15 and Day 3. On Days 1 and 2, patients received a blinded, fixed dose of
ZUBSOLV (5.7/1.4 mg and 5.7/1.4 or 11.4/2.8 mg, respectively) or generic
buprenorphine monotherapy (8 mg and 8 or 16 mg, respectively). On Day 3, the
patients on generic buprenorphine were switched to Suboxone Film and patients in
the ZUBSOLV arm continued to receive ZUBSOLV. Stabilization doses were titrated
to a maximum daily dose of 17.1/4.2 mg and 24/6 mg for ZUBSOLV and Suboxone,
respectively, based upon clinical symptoms.

Results of the study showed no differences in retention at Day 3 in the per
-protocol [ZUBSOLV arm: 93.3% (309/329); generic buprenorphine arm: 92.6%
(302/326); p=0.512] or full analysis set [ZUBSOLV arm: 93.2% (357/383); generic
buprenorphine arm: 91.7% (344/375); p=0.440]. Clinically and statistically
significant improvements were observed in Clinical Opiate Withdrawal Scale
(COWS), Subjective Opiate Withdrawal Scale (SOWS), and opioid cravings VAS
(Visual Analogue Scale) total scores.

Suboxone is a registered trademark of Indivior PLC.

About Study OX219-007
Study OX219-007 (n=310) was a prospective, randomized, multicenter, blinded,
parallel-group, active-controlled study comparing advanced formulation ZUBSOLV
compared to generic buprenorphine monotherapy for induction of opioid
maintenance therapy.

The primary endpoint was retention in treatment at Day 3. On Days 1 and 2,
patients received a blinded, fixed dose of ZUBSOLV (5.7/1.4 mg and 5.7/1.4 or
11.4/2.8 mg, respectively) or buprenorphine (8 mg and 8 or 16 mg, respectively).
On Day 3, all patients received open-label ZUBSOLV (5.7/1.4 or 11.4/2.8 mg).

Results of the study showed 91.8 percent (235/256) of patients were retained at
Day 3 [generic buprenorphine group: 95.3% (122/128); ZUBSOLV group: 88.3%
(113/128); p=0.040]. Clinically and statistically significant improvements were
observed in COWS, SOWS, and Craving VAS scores for patients in both randomized
groups. In addition, improvements in these scores during the blinded phase
demonstrated no clinical difference between products.

About Orexo AB
Orexo is a specialty pharmaceutical company commercializing its proprietary
product ZUBSOLV ® for maintenance treatment of opioid dependence in the U.S.
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 Exchange 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, Sweden.
www.orexo.com

About Orexo US, Inc.
Orexo US, Inc. is an emerging specialty pharmaceutical company marketing
improved treatments for opioid dependence using proprietary drug delivery
technology. To receive more information please contact Orexo at 1-855-ZUBSOLV.
www.orexo-us.com (http://httP/www.orexo-us.com)

For information about opioid dependence, please visit www.outthemonster.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 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 tests should be monitored before and
during treatment. Children who take ZUBSOLV sublingual tablets can have severe,
possibly fatal, respiratory depression. Emergency medical care is critical. Keep
ZUBSOLV sublingual tablets out of the sight and reach of children.

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.

Further information on ZUBSOLV can be found at www.zubsolv.com

Important Safety Information

Keep ZUBSOLV in a secure place away from children. If a child accidentally takes
ZUBSOLV, this is a medical emergency and can result in death. Get emergency help
right away

ZUBSOLV can cause serious and life-threatening breathing problems. Call your
doctor right away or get emergency help if (a) you feel faint, dizzy, or
confused; (b) your breathing gets much slower than is normal for you; (c) you
feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred
speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes
and breathing. In an emergency, have family members tell the emergency
department staff that you are physically dependent on an opioid and are being
treated with ZUBSOLV

The most common side effects of ZUBSOLV include: headache, drug withdrawal
syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased
sweating, swelling of the extremities, and constipation. Tell your doctor about
any side effect that bothers you or that does not go away

Do not switch from ZUBSOLV to other medicines that contain buprenorphine without
talking with your doctor. The amount of buprenorphine in a dose of ZUBSOLV is
not the same as the amount of buprenorphine in other medicines that contain
buprenorphine. Your doctor will prescribe a starting dose of buprenorphine that
may be different than other buprenorphine-containing medicines you may have been
taking

ZUBSOLV contains an opioid that can cause physical dependence. Do not stop
taking ZUBSOLV without talking to your doctor. You could become sick with
uncomfortable withdrawal signs and symptoms because your body has become used to
this medicine. Physical dependence is not the same as drug addiction. ZUBSOLV is
not for occasional or "as needed" use

An overdose, and even death, can happen if you take benzodiazepines, sedatives,
tranquilizers, or alcohol while using ZUBSOLV. Ask your doctor what you should
do if you are taking one of these. You should not drink alcohol while taking
ZUBSOLV, as this can lead to loss of consciousness or even death

Do not inject ("shoot-up") ZUBSOLV. Injecting ZUBSOLV may cause life-threatening
infections and other serious health problems. Injecting ZUBSOLV may cause
serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety,
sleep problems, and cravings

Before taking ZUBSOLV, tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal
supplements

Before taking ZUBSOLV, tell your doctor if you are pregnant or plan to become
pregnant. It is not known if ZUBSOLV will harm your unborn baby. If you take
ZUBSOLV while pregnant, your baby may have symptoms of withdrawal at birth. Talk
to your doctor if you are pregnant or plan to become pregnant

Before taking ZUBSOLV, tell your doctor if you are breastfeeding or plan to
breastfeed. ZUBSOLV can pass into your breast milk and may harm the baby. Talk
to your doctor about the best way to feed your baby if you take ZUBSOLV. Monitor
your baby for increased sleepiness and breathing problems

Do not drive, operate heavy machinery, or perform any other dangerous activities
until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and
slow reaction times. This may happen more often in the first few weeks of
treatment when your dose is being changed, but can also happen if you drink
alcohol or take other sedative drugs when you take ZUBSOLV

ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine,
which can be a target for people who abuse prescription medicines or street
drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give
your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving
away this medicine is against the law

To report negative side effects associated with taking ZUBSOLV, please call 1
-888-982-7658. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Please see full Prescribing Information and Medication Guide for ZUBSOLV.

Orexo AB (publ) discloses the information provided herein pursuant to the
Financial Instruments Trading Act and/or the Securities Markets Act. The
information was submitted for publication at 08:30am CET on August 11, 2015.