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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 invites to a Zubsolv™ (OX219) information meeting on September 21 in Stockholm

    Uppsala, September 17, 2012 – Orexo today announces the invitation of analysts, investors and media to an information meeting about Zubsolv™ (OX219), a product developed for treatment of opioid dependence, this coming Friday September 21. Date:            Friday, September 21 2012Time:            10:00am-1:00pm (lunch included)Place:           ABG, Sundal Collier AB, Regeringsgatan 65, 5 floor, StockholmRSVP:          registration ASAP to asa.henriksson@abgsc.se As previously announced, Orexo submitted on September 5 a New Drug Application (NDA) to the FDA for Zubsolv™ (OX219),

    Orexo reports successful achievement of product stability data for OX219 – submission of the US file now advanced 5 months to September 2012

    Swedish specialty pharmaceutical company Orexo today communicated that it projects a late Q3 regulatory submission to the US regulatory agency FDA of its treatment of opioid dependence, OX219. Opioid dependence is in the US increasingly being recognized as a major health problem, with over two million Americans affected and costing the society an estimated USD 25 billion in related health care cost.As communicated in July, following the pre-NDA meeting with FDA, the final product development task outstanding before OX219 could be submitted in the US, was completion of certain product

    Interim report, January-June 2012

    STRONG REVENUE GROWTH AND CASH FLOW. ALL CLINICAL STUDIES FOR KEY PROJECT OX219 COMPLETED AHEAD OF PLAN.Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2011. During the period · Net revenues amounted to MSEK 166.5 (96.7). · Abstral royalty revenues increased by 66 percent to MSEK 55.8 (33.6). · Cash flow from operating activities amounted to MSEK 172.4 (-31.2). · Earnings after tax were MSEK -32.8 (-65.2). · EBITDA amounted to MSEK -24.7 (-56.3). · Earnings per share were SEK -1.10 (-2.

    Orexo takes large step forward on the road to improve treatment for people dependent on opioid pain killers

    Uppsala, Sweden – July 2, 2012 - Orexo AB (“Orexo”) has ahead of schedule completed a crucial comparative bioavailability study for its product OX219. The market in the US alone for this type of treatment for people addicted to opioid pain killers, amounted to USD 1.3 bn in 2011. The study, which met the expectations of the key pharmacokinetic parameters, was completed on June 30 and is the final clinical study as discussed with the FDA, which means that all pivotal clinical data has now been generated. In the study, OX219 was tested against brand leader Suboxone®, where it demonstrated

    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 positive results supporting OX219 for treatment of opioid dependence

    Uppsala, Sweden, September 21, 2011 – Orexo AB (STO: ORX) today announced that it has obtained positive results in a clinical study with OX219, which is being developed for the treatment of opioid dependence. The study was designed to decide the commercial formulation and dose for OX219. Orexo has consulted with the FDA to define the optimal development path for OX219, and will plan to pursue a final drug development and registration path according to the 505 (b) (2) procedure. This enables regulatory clearance based on documentation from an already approved drug, in this case Suboxone®.

    Orexo announces successful completion of rights issue providing gross proceeds of about SEK 250 million

    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 through

    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

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