Orexo Enters an Exclusive Reimbursement Agreement with UnitedHealth Group and OptumRx for ZUBSOLV®

| Source: Orexo AB
Uppsala, Sweden – March 12, 2014 – Orexo AB, the manufacturer of ZUBSOLV®
(buprenorphine and naloxone) sublingual tablets (CIII), announced a multi-year
agreement with UnitedHealth Group® and OptumRx® providing preferred coverage and
reimbursement of ZUBSOLV®.

Under the agreement, ZUBSOLV will be given preferred, Tier 2 brand status on
UnitedHealth Group commercial employer and individual formularies managed by
OptumRx for the maintenance treatment of opioid dependence through June 30,
2014. Beginning on July 1, 2014 ZUBSOLV will become the only
buprenorphine/naloxone combination product on all of UnitedHealth’s closed and
highly managed health plan formularies, inclusive of all brand and generic

“Orexo’s mission is to increase access to medication-assisted treatment plans,
help reduce relapse rates and improve successful patient outcomes – all
critically important in the face of the growing opioid dependence epidemic in
the US,” said Robert DeLuca, R.Ph., President, Orexo U.S., Inc. “Our long term
strategic partnership with UnitedHealth Group and OptumRx enables us to assist a
greater number of patients who are incorporating a treatment option such as
ZUBSOLV into their recovery plans.”

“Orexo is dedicated to broadening the market access position for ZUBSOLV and
this agreement with UnitedHealth Group and OptumRx is an important step in that
direction. It is a major achievement and endorsement as health insurers with a
firm control over their formularies recognize ZUBSOLV as the preferred
buprenorphine/naloxone formulary product for the maintenance treatment of opioid
dependence” said Nikolaj Sorensen, CEO and President of Orexo.

ZUBSOLV is an advanced sublingual tablet formulation for maintenance treatment
of opioid dependence with high bioavailability, a fast dissolve time, small
tablet size, and menthol flavor. The advanced formulation provided by ZUBSOLV
was specifically designed to meet the needs expressed by patients. Meeting
patient needs may have the potential to improve patient adherence, thus reducing
relapse rates and improving successful patient outcomes. It is the only opioid
dependence treatment option available in the highest level of child resistant,
unit dose, F1 packaging, designed to reduce the chance of unintended pediatric

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

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

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

About Orexo
Orexo is a specialty pharmaceutical company with commercial operations in the
United States and R&D in Sweden developing improved treatments using proprietary
drug delivery technology. The company is commercializing its proprietary
product, ZUBSOLV® (buprenorphine and naloxone), in the United States for
maintenance treatment of opioid dependence. 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, US and Japan.
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
For information about Orexo, please visit www.orexo.com

About Orexo U.S., Inc.
Orexo U.S., Inc. is a subsidiary to Orexo AB, a specialty pharmaceutical
company. The subsidiary markets improved treatments for opioid dependence using
proprietary drug delivery technology. To receive more information, please
contact Orexo at 1-855-ZUBSOLV.


• 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

• 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 08:45 am CET on March 12, 2014.