Regulatory News:

Uppsala, Sweden – July 7, 2016 – Orexo AB applauds the Administration’s announcement yesterday to increase access to the treatment of opioid dependence in the US, by increasing the cap on the number of patients that can be treated by physicians from 100 to 275, starting 30 days after publication in the Federal Register. Additionally, we commend the strong bipartisan Congressional support of this announcement. We look forward to Congress passing additional legislation further supporting increased access to appropriate patient care.

More than 5 million US citizens are misusing opioids and at least 2 million are opioid dependent. Today about 640,000 patients are in treatment with buprenorphine. Many struggle to find a qualified physician due to the patient cap which has been a significant hurdle in many regions of the US. In several instances, the lack of access to a qualified physician has led to a vicious cycle forcing patients to obtain their treatment on the street in a drug abusing environment perpetuating the risk of continued addiction.

Orexo strongly believes that medication assisted treatment with buprenorphine containing products, prescribed by a qualified physician should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. With the initiative announced, opioid dependence treatment takes an important step towards open and affordable access to treatment in an appropriate clinical setting.

“I am encouraged by the initiative announced, which will be a significant change for many patients suffering from opioid dependence and save lives. For Orexo and our product Zubsolv® this change will be important for our continued sales and market share growth. I am proud of the incredible efforts our US team has made in Washington DC during the last 12 months to support the legislators and government with information and knowledge leading to this game changing decision for patients, physicians and for Orexo” said Nikolaj Sørensen, CEO and President of Orexo AB.

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.

For more information about Orexo and Zubsolv, please visit www.orexo.com and www.zubsolv.com.

This is information is information that Orexo AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on July 7, 2016.

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