New regulations will expand access to treatment of opioid dependence in the US

Uppsala, Sweden – September 18, 2015 – Orexo AB (publ) informs, that yesterday
the United States Department of Health and Human Services (HHS) Secretary Sylvia
M. Burwell announced important steps to increase access to the treatment of
opioid dependence in the US.

According to HHS, overdoses from prescription opioid pain relievers claimed more
than 16,200 lives in 2013. “The opioid epidemic knows no boundaries; it touches
lives in cities, rural counties and suburban neighborhoods across the country,”
said Secretary Burwell. The resulting health, social, and economic consequences
for communities across the country are enormous.

This announcement to increase access to Medication Assisted Treatment (MAT)
builds on previous efforts by HHS and the US Congress to expand patient
treatment options and develop an evidence-based initiative focused on three
promising areas: informing opioid prescribing practices, increasing the use of
naloxone, and increasing access to MAT.

A key action mentioned by HHS includes revising the regulations related to
buprenorphine to safely and effectively increase patient access. “This cap on
prescribing limits the ability of some physicians to prescribe to patients with
opioid use disorder. The HHS revision to the regulation will be developed to
provide a balance between expanding the supply of this important treatment,
encouraging use of evidence-based MAT, and minimizing the risk of drug
diversion.” (HHS press release September 17, 2015, link
www.hhs.gov/news/press/2015pres/09/20150917a.html.)

Orexo will continue monitoring the progress of these initiatives and identify
areas where Orexo can provide support for improving patient access to treatment
of opioid dependence in the US and across the world.

“Orexo is encouraged by the initiatives announced by HHS and their continued
commitment to addressing the opioid epidemic. On a daily basis, through our
interactions with physicians, we learn of their frustrations regarding the
inability to treat more patients suffering from opioid dependence. We recognize
this revision to the current regulations as another positive step forward that
expands patient access to treatment and MAT,” said Nikolaj Sørensen, CEO and
President of Orexo AB.

For further information, please contact
Nikolaj Sørensen, President and CEO
Tel: +46 18 780 88 00 or + 46 70 350 78 88, E-mail: ir@orexo.com

About Orexo
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 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

For information about ZUBSOLV and opioid dependence, please visit
www.zubsolv.com and www.outthemonster.com.