Orexo Announces the Launch of Abstral® in Japan

UPPSALA, Sweden--()--Regulatory News:

Orexo AB, “Orexo” (STO:ORX) (OTCQX: ORXOY; NASDAQ OMX Stockholm: ORX) announces today that Kyowa Hakko Kirin Co., Ltd has commenced the launch of Abstral® in Japan.

Abstral is a rapidly-disintegrating, sublingual (under the tongue) rapid acting formulation of fentanyl citrate, a well-established opioid, and is indicated for the management of breakthrough pain in cancer patients.

Kyowa Hakko Kirin (KHK) licensed the right for Abstral in Japan in 2003 and has completed a dedicated clinical development program for the product in the territory. Abstral will be jointly distributed by KHK and Hisamitsu Pharmaceutical Co., Inc. These companies are well established within the field of cancer pain and have collaborated since 2010. Orexo will receive a single digit royalty on net sales of Abstral in Japan.

The manufacturing and marketing approval of Abstral in Japan was received on September 20, 2013 ahead of expectations, and on November 19, 2013 Abstral was listed on the Japanese National Health Insurance Drug Price List.

Abstral is the leading fast-acting fentanyl product in Europe, where it achieved full year sales of EUR 41 million (SEK 380 million) in 2012. In the first nine months of 2013, sales exceeded EUR 39 million (SEK 360 million) corresponding to 29 percent growth versus prior year.

About Abstral®

Abstral is a rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl, a well-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for chronic pain. Abstral is approved in the US, EU, Canadian and Japanese markets.

About Orexo AB

Orexo 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®, for maintenance treatment of opioid dependence, in the United States. Zubsolv is a novel 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 AB, with its headquarters in Sweden, is listed on NASDAQ OMX Stockholm Exchange, under the symbol “ORX”, and its American Depositary Receipts (ADRs) trade on the OTCQX marketplace in the U.S. under the symbol “ORXOY”. The largest shareholders are Novo A/S and HealthCap.

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

About Kyowa Hakko Kirin

Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology and immunology/allergy. Kyowa Hakko Kirin leverages antibody-related leading-edge technologies to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world.

For more information, visit www.kyowa-kirin.com .

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 09:30 am CET on December 12, 2013.

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Contacts

Orexo AB:
Nikolaj Sørensen
President and CEO
Tel: +46-(0)18 780 88 00
E-mail: ir@orexo.com

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Contacts

Orexo AB:
Nikolaj Sørensen
President and CEO
Tel: +46-(0)18 780 88 00
E-mail: ir@orexo.com