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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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    Zubsolv® now launched in the EU, which triggers a EUR 3m milestone payment to Orexo

    Uppsala, Sweden – June 18, 2018 - Orexo AB today announces that its partner Mundipharma has initiated the launch of Zubsolv (buprenorphine and naloxone sublingual tablet), for use in the treatment of opioid dependence, in the EU. The launch is triggering a milestone payment ofEUR 3 million (approx. SEK 30.6 million) from Mundipharma. It is estimated that there are approximately 1.3 million high-risk opioid users in Europe. Although estimates vary significantly, the vast majority of high-risk opioid users use heroin. “Taking the step out in Europe, is yet another important milestone

    CHMP positive opinion for opioid dependence treatment with Zubsolv® (buprenorphine and naloxone) in Europe

    ·First regulatory milestone for Mundipharma/Orexo partnership in Europe Cambridge, UK, and Uppsala, Sweden – September 15, 2017 – Mundipharma and Orexo AB (publ.) today announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Zubsolv (buprenorphine and naloxone sublingual tablet) for use in the treatment of opioid dependence. The European Commission will now review the CHMP opinion and a final decision is expected in Q4, 2017. The two companies have worked collaboratively in completing the

    Mundipharma and Orexo announce EU regulatory submission for Zubsolv®

    ·  Mundipharma and Orexo make first EU regulatory submission for Zubsolv® (buprenorphine and naloxone) sublingual tablet. ·  Zubsolv was approved in the US in 2013 for the maintenance treatment of opioid dependence, as part of a complete treatment plan.  ·  Opioid dependence represents a significant public health problem; across Europe there are an estimated 1.3 million high-risk opioid users. Cambridge, UK and Uppsala, Sweden– 4 October, 2016 Mundipharma and Orexo AB (publ.) have announced the submission of a regulatory submission of a Marketing Authorisation Application (MAA)

    Orexo signs license agreement with Mundipharma, which obtains ex-US global rights to Zubsolv®

    Uppsala, Sweden - June 30, 2016 - Orexo AB (publ.) today announced an agreement granting Mundipharma’s network of independent associated companies´ exclusive global (ex-US) rights to Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII), for treatment of opioid dependence. Under the terms of the agreement Orexo receives an upfront payment of 7 million euros. Pending marketing authorizations and commercial milestones Orexo is also entitled to receive further milestone payments and up to low double digit royalties on future net sales. Orexo will also be compensated for specific

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