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  • Orexo
    Box 303 751 05 Uppsala
    +46 (0)18 780 88 00
    +46 (0)18 780 88 88
    http://www.orexo.com

    • Quotes

    With the acquisition of the rights to two digital health products from GAIA and the appointment of Dennis, a thought leader in the digital health industry in the US, we are well positioned to lead this development within the complementary disease areas of our pharmaceutical business.
    Nikolaj Sørensen, President and CEO
    Our strategy is to focus on solutions with scientifically proven therapeutic effect which will benefit the healthcare system as a whole and more importantly patients.
    Nikolaj Sørensen, CEO, about Digital Therapies
    I am convinced that DTx will become an integral and natural part of addiction treatment in the future. This digital therapy for OUD patients is perfectly positioned with Orexo’s competences and commercial organization in the US.
    Nikolaj Sørensen, President and CEO
    Mundipharma Australia has been a good partner in the approval process and we are confident that their experience and infrastructure will create a strong foundation for a successful launch of Zubsolv®
    Nikolaj Sørensen, President and CEO
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    Orexo announces the launch of Abstral® in Japan

    Uppsala, Sweden – December 12, 2013 – Orexo AB, “Orexo” (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

    Orexo sells Abstral® in the United States to Galena Biopharma, Inc.

    Telephone conference March 18 at 1:00pm CETUppsala, Sweden – March 18, 2013 – Orexo AB today announced that it sold Abstral® (fentanyl) Sublingual Tablets in the United States to Galena Biopharma, Inc. (NASDAQ: GALE). Under the terms of the agreement, Galena Biopharma will pay Orexo US$10 million upfront and an additional US$5 million within the first twelve months after signing, plus low double digit royalties and milestone payments based on pre-specified sales levels. Galena Biopharma is a biopharmaceutical company developing innovative, targeted oncology treatments that address major

    Number of shares and votes in Orexo

    Uppsala, Sweden – October 31, 2012 - The number of shares and votes in Orexo has changed as a result of the exercise of warrants. Today, the last trading day of the month, there are in total 29,922,909 shares and votes in the company. For further information, please contact:Carl-Johan Blomberg, CFOTel: +46-706 33 67 11, Email: carl-johan.blomberg@orexo.com About OrexoOrexo AB is an emerging specialty pharma company developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially

    Orexo announces decision to explore strategic alternatives for commercialization in the US

    Uppsala, Sweden – October 4, 2012 – Orexo, a Swedish specialty pharmaceutical company with a focus on innovative sublingual drug delivery technologies, today announced that it has retained Guggenheim Securities, LLC as its financial advisor to assist in the Company’s review and evaluation of a full range of strategic alternatives. The Board of Directors initiated this review in conjunction with the Company’s ongoing evaluation of its US commercial plan, with the aim of enhancing both commercial prospects for the Company’s products and shareholder value. Based on the recent submission of

    Orexo acquires all US rights for Abstral and receives a net cash consideration of MSEK 610

    Telephone conference today June 4 at 10:00am CETUppsala, Sweden – June 4, 2012 - Orexo AB (“Orexo”) today announced the acquisition of the US rights to Abstral® from ProStrakan Group plc (“ProStrakan”) and the restructure of the existing royalty arrangement for the product in EU and Rest-of-the-World markets (ROW). Completion of the transaction in the US is anticipated by January 1, 2013, while EU and ROW were completed as of June 1, 2012. Orexo receives 610 MSEKFixed payments of 610 MSEK to be received by Orexo as part of the revised agreement, combined with expected future royalties

    Orexo acquires US commercial rights of Abstral and ProStrakan acquires the corresponding rights in the EU and rest of the world

    Uppsala, Sweden and Galashiels, UK – June 4, 2012 - Orexo AB (“Orexo”) and ProStrakan Group plc (“ProStrakan”) jointly announce today that the companies have reconfigured the commercial rights to the product, Abstral, in various territories worldwide. Abstral is the novel, 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. ProStrakan, which is a subsidiary of global speciality

    Abstral EU success continues. Orexo receives sales milestone of 3.3 MEUR.

    Uppsala, Sweden – May 25, 2012 - Orexo AB (STO: ORX) announced today that accumulated sales of Abstral has surpassed 65 MEUR, which was faster than earlier anticipated and results in a 3.3 MEUR milestone payment from ProStrakan. Abstral is the leading new fast acting fentanyl product in Europe and this position has been further strengthened during the first four months of 2012. Abstral has continued to win market share. The growth during first quarter of 2012 was 39%, driven especially by the key markets France, Italy and Spain. Anders Lundström, Chief Executive Officer, of Orexo said:

    Orexo AB focuses its business and reduces costs

    Uppsala, Sweden - March 6, 2012 - Orexo AB is focusing its development activities to the three proprietary programs OX219, OX51 and OX27. The total requirement for resources will thereby be reduced with up to 35 full time employees.The personnel reduction, which will have full effect in 2013, is expected to lower the costs by a total of SEK 30 million annually. Negotiations with trade union representatives will commence immediately. The reduction in personnel is expected to be completed during the second quarter of 2012."The focus of our business activities will now be fully in line

    Orexo announces addendum to prospectus made public

    Read more about Orexo Rights Issue at: http://www.orexo.com/en/Investor-Relations/Rights-issue---Important-Information/ For further information, contact:Anders Lundström, President and CEO of OrexoTel: +46 (0)70-667 22 66E-mail: anders.lundstrom@orexo.com   About OrexoOrexo is a pharmaceutical company focusing on developing treatments for pain and inflammation. The company has four commercialized products, several projects developed in partnership as well as three proprietary development programs. Orexo’s registered products are Abstral® for the treatment of break

    Orexo announces successful completion of the first clinical trial with OX27

    Uppsala, Sweden, June 14, 2011 - Orexo AB (STO: ORX) announces a successful outcome following completion of the first OX27 pharmacokinetic trial. OX27 is a sublingual tablet developed to optimize the treatment of breakthrough pain in cancer patients. The market for treatment of breakthrough pain in cancer patients is approximately 1.5 billion USD in Europe and United States. In the completed study three different doses of OX27 were administered to healthy subjects. The plasma concentration curves obtained indicate that the active pharmaceutical ingredient was rapidly absorbed and

    Orexo AB announces that Robin Wright resigns as CFO

    Uppsala, April 11, 2011 - Orexo AB (STO: ORX) announces today that Robin Wright has decided to leave the company and resign from the position of Chief Financial Officer as of April 30. The process of finding a new Chief Financial Officer has been initiated. Anders Lundström, President and CEO of Orexo:“We have greatly appreciated Robin’s contributions to the company’s success during the last three years. His extensive experience has been of great value, both in his role as CFO and as Head of Business Development. I wish him the best in his future endeavours.”   Contact details:

    Abstral® launched and now available in the United States

    Uppsala, April 4, 2011 - Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has launched Abstral in the United States. Abstral, which is the only fast-acting sublingual tablet for the treatment of breakthrough cancer pain, is now available to patients in the US. In 2010 the market value for fast-acting fentanyl products was $530m. (Source: Wolter Kluwers).  Abstral was approved by the US Food and Drug Administration (FDA) in January 2011, and is the first product to be approved in the US with the FDA mandated class Risk Evaluation and Mitigation

    Report from Orexo AB’s extraordinary shareholders’ meeting, 16 February 2011

    The extraordinary general meeting resolved on February 16 to adopt a performance-based, long-term incentive program 2011/2021 for senior executives of Orexo. For more information about the incentive program, reference is made to the complete proposal which is attached to this report.    For further information, contact:Anders Lundström, President & CEOTel: +46 (0)706-67 22 66Email: anders.lundstrom@orexo.com  Robin Wright, EVP and CFOTel: +44 7720 300025Email: robin.wright@orexo.com Note:This is information that Orexo AB (publ.) is required to disclose pursuant to

    Anders Lundström to be the new CEO of Orexo

    Uppsala, January 13, 2011 - Orexo AB (STO: ORX) announces today that Anders Lundström has been appointed as its new CEO, to lead the company through its commercial development. He comes from Biogen Idec in the US, one of the world’s most successful biotech companies."This is a dream recruitment. Anders Lundström has the perfect profile to be the new CEO of Orexo. Mr. Lundström has extensive international experience and a strong commercial track record. He will also establish a market-oriented approach early in our product development. This is crucial in Orexo’s current strategic phase with

    FDA Approval for Abstral (Fentanyl) Sublingual Tablets - US launch planned for Q1 2011

    Uppsala, January 10, 2011 - Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has received approval from the US Food and Drug Administration (FDA) for Abstral®. Abstral® is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain. “This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs

    Orexo reports phase I trial results for OX219, a novel sublingual tablet formulation for the treatment of opioid dependence

    Uppsala, Sweden, December 14, 2010 - Orexo AB (STO: ORX) announces successful completion of the initial pharmacokinetic trial in the OX219 project. In the comparative bioavailability study, the OX219 buprenorphine/naloxone sublingual tablet formulation demonstrated favourable profiles compared to the comparator Suboxone®, which is the market leading product for treatment of opioid dependence. Global value of the opioid dependence market today is approximately US$ 1.4 billion. Based on the positive results, Orexo will be meeting with the FDA during Q1-2011 to discuss the development program

    Orexo announces new sales figures for Abstral™ from its partner ProStrakan and updates on the US approval

    Uppsala, Sweden, November 16, 2010 - Orexo AB (STO: ORX) announces that its sales partner in the EU and USA for Abstral™, ProStrakan Group plc (“ProStrakan”) yesterday issued its interim report, which gave further information on progress with Abstral™, Orexo’s leading sublingual fentanyl product for treatment of breakthrough cancer pain. Abstral™ recorded sales of £14.1m (156 MSEK) in the first 10 months of the year, representing growth of 345% over the corresponding period in 2009. In September 2010, ProStrakan launched Abstral™ in Italy which completes the roll-out of the product across

    Orexo AB (publ.) – Interim report, January-September 2010

    Uppsala, November 10, 2010 - Abstral™ for treatment of breakthrough cancer pain continued to grow stronglyKey events during the period · Net revenues amounted to MSEK 101.4 (208.2). · Cash flow from operating activities as a negative MSEK 13.7 (neg:117.7) · Royalties from Abstral™, Orexo’s leading sublingual fentanyl treatment for breakthrough cancer pain, increased to MSEK 30.3 (6.3) · The loss after tax was MSEK 91.4 (loss: 40.1). · The loss per share was SEK 3.90 (loss: 1.78). · Cash and cash equivalents at the end of the period totaled MSEK 165.6 compared with MSEK

    Orexo signs agreement for Abstral™ for the Middle East and Africa

    Uppsala, September 16, 2010 - Orexo AB (STO: ORX) announces today that an exclusive licensing and distribution agreement has been signed with NewBridge Pharmaceuticals for Abstral™, Orexo´s product for the treatment of breakthrough cancer pain. The agreement grants NewBridge rights to seek approval for Abstral™ in the Middle East and Africa and, where approval is granted, to market and sell the product in these territories. The agreement covers 64 countries across the Middle East and Africa, and excludes Israel where the product is already partnered. Under the terms of the agreement,

    Update on the FDA review for Abstral™

    Uppsala, September 7, 2010 - Orexo AB (STO: ORX) announces that the US Food and Drug Administration (“FDA”) has informed Orexo’s partner, ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, that it will not yet be making a decision under the Prescription Drug User Fee Act (“PDUFA”) for Abstral™. Discussions between ProStrakan and the FDA on the review of Abstral™ are ongoing and constructive and are focused on the Risk Evaluation and Mitigation Strategy (“REMS”) programme. However due to the ongoing nature of these discussions, the FDA has indicated to

    Orexo confirms Abstral PDUFA date update

    Uppsala, Sweden, June 2, 2010 –Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has today announced that the US Food and Drug Administration (“FDA”) has extended the review period under the Prescription Drug User Fee Act (“PDUFA”) for AbstralTM by three months. The FDA has issued the extension following its earlier request for additional information on the Abstral Risk Evaluation and Mitigation Strategy (“REMS”). ProStrakan has submitted this information. Abstral is a rapidly-disintegrating tablet for sub-lingual (under the tongue) administration of

    Orexo reports continued strong AbstralTM sales in Europe

    Uppsala, May 18, 2010 – Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has announced that AbstralTM continues to show strong sales development in 2010. AbstralTM was launched across Europe during the course of 2009 and ProStrakan reported sales of £5.8 million in its first year on the market. In the first four months of 2010 AbstralTM has already recorded sales of £5.0 million. The successful establishment in each of the countries in which it has been launched is demonstrated by the following market shares (estimates based on the number of doses

    Orexo AB (publ.) – Year-end Report January-December 2009

    Uppsala, February 17, 2010 Orexo AB (publ) – Year-end Report January–December 2009 Key events during the year • Net revenues totaled MSEK 236.1 (233.3). • The loss after tax was MSEK 98.1 (loss: 103.1). • The loss per share amounted to a loss of SEK 4.32 (loss: 4.77). • Cash and cash equivalents at year-end totaled MSEK 87.4 (188.2). • Abstral was launched in UK, Germany, France, Spain and Greece. • In March, the FDA approved Orexo’s product Edluar for the short-term treatment of insomnia. The approval resulted in Orexo receiving a milestone payment of MUSD 5 from Meda. • In August, Orexo

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