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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 sees very limited exposure to the UK and the British pound

    Uppsala, Sweden – June 21, 2016 In response to recent week´s media attention to companies exposure to brexit and GBP Orexo AB (publ) today clarifies that its exposure to the UK and thereby fluctuations in the GBP is very limited. Orexo has no direct income in GBP and has only limited indirect exposure to GBP through the Abstral® partner, Kyowa Kirin’s (former Prostrakan), sales of Abstral in the UK. Royalties from sales of Abstral in the UK amounts to less than 1 percent of Orexo’s annual net revenue and is invoiced by Orexo in euro. Earlier Orexo has earned one-off Abstral milestone

    Orexo receives MGBP 5 milestone payment for Abstral® in Europe and records OX-MPI non-cash impairment charge of MSEK 62

    Uppsala, Sweden – December 11, 2015 – Orexo AB (publ) today announced that the annual sales of Abstral in Europe has passed MEUR 67.5 during 2015, which triggers a milestone payment of MGBP 5 (approx. MSEK 63.8) to Orexo AB (”Orexo”) from the commercial partner in Europe ProStrakan Group plc (”ProStrakan”). According to the agreement from June 2012, with ProStrakan for Abstral sales in Europe, Orexo receives a fixed and non-conditional royalty of MGBP 55, a variable royalty for annual sales exceeding MEUR 42.5 and milestone payments of up to MGBP 10. With the announced MGBP 5 milestone

    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:

    Abstral® launches in Canada

    Uppsala, Sweden, June 14 2011 – Through its local partner, Orexo now initiates marketing and sales of the pain treatment Abstral in Canada.In 2008, ProStrakan, who markets Abstral in Europe and the U.S., licensed its rights in the Canadian market to Paladin Labs Inc., which now launches the treatment of breakthrough pain in cancer patients in the Canadian market.Paladin Labs is a specialty pharmaceutical company focused on marketing of innovative drugs in Canada. The company also markets the pain products Tridural®, Metadol® and Pennsaid®. In February 2011 Abstral was approved by

    Abstral® approved in Canada

    Uppsala, Sweden– February 22, 2010 – Orexo AB (STO: ORX) today announces that ProStrakan’s partner, Paladin Labs Inc. has been informed by Health Canada, the Canadian Government Department with responsibility for public health, that it has approved Abstral®. Abstral is a rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl. The product is approved for the treatment of breakthrough pain in patients receiving opioid analgesics for underlying chronic cancer pain. Orexo has out-licensed the rights for Abstral in Europe and North America to ProStrakan. The rights

    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

    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) – Interim report, January-March 2010

    Uppsala, May 5, 2010 Further strong sales development for Abstral • Net revenues amounted to MSEK 36.4 (114.9). 1) • Abstral royalty increased to MSEK 8.5 (1.3) • Abstral approved in Italy and TUER 650 in milestones received • The loss after tax was MSEK 27.6 (profit: 26.3). • The loss per share before dilution was SEK 1.18 (profit: 1.20). • The loss per share after dilution amounted to SEK 1.18 (1.15). • Cash and cash equivalents at the end of the quarter totaled MSEK 50.4 (148.2). • As per April 7 cash position amounted to MSEK 161. Torbjörn Bjerke, President and CEO, comments: During the

    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

    Orexo confirms Canadian Regulatory Filing of Abstral

    Uppsala, February 4, 2010 – Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has announced that the New Drug Submission made by their Canadian partner, Paladin Labs Inc., for AbstralTM has been accepted for review by Health Canada, the Canadian Government Department with responsibility for public health. AbstralTM, developed by Orexo AB is a new, rapidly disintegrating, sublingual formulation of fentanyl, a long-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid

    Orexo confirms FDA acceptance of Abstral filing

    Uppsala, Sweden, 6th October, 2009 - Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK), has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug Administration (FDA). Abstral is a new, rapidly disintegrating, sublingual formulation of fentanyl, a long-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for their chronic pain. Subject to successful completion of the US approval process,

    Orexo AB (publ) – Interim report, January - June 2009

    Key events during the period • Net revenues amounted to MSEK 144.6 (80.2). • The loss after tax was MSEK 30.5 (loss: 90.5). • The loss per share was SEK 1.38 (loss: 4.19). • Cash and cash equivalents at the end of the quarter amounted to MSEK 137.2 (247.1). • The US Food and Drug Administration (FDA) approved Orexo’s EdluarTM product for the short-term treatment of insomnia. The approval meant that Orexo received a milestone payment from Meda of MUSD 5. • Orexo signed an exclusive development agreement with a large healthcare company. The agreement covers the development of Orexo’s OX17

    Abstral™ file submitted to the FDA for approval in the USA

    Uppsala, Sweden, August 6, 2009 - Orexo AB (STO: ORX) today announces that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc (LSE: PSK), has submitted the New Drug Application (NDA) for Abstral™ (for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US Food and Drug Administration (FDA). The filing of AbstralTM will generate a milestone payment to Orexo as part of the agreement with ProStrakan for North America that in total can give USD 27 million in certain regulatory and sales milestone payments. In addition, Orexo will

    Orexo announces that Abstral is ready for launch in France

    Uppsala, Sweden, 30th June, 2009 – Orexo (STO: ORX) announces that ProStrakan Group plc (LSE: PSK) Orexo’s partner for Abstral in Europe and North America, today confirms that it has completed the reimbursement pricing process with the French authorities for its pan-European breakthrough cancer pain product, Abstral, earlier than expected and, as a result, plans to launch this product in the important French market next month. Abstral is a new formulation of fentanyl, a long-established opioid, used for the management of episodes of breakthrough pain experienced by cancer patients who are

    Orexo’s AbstralTM receives two further large EU market approvals in France and Spain

    Orexo (NASDAQ-OMX:ORX), announces that AbstralTM has received Marketing Authorisation from the French and Spanish regulatory authorities for the treatment of breakthrough cancer pain.AbstralTM is expected to be launched during the second half of 2009 in France and Spain, following pricing and reimbursement negotiations with the relevant authorities, by ProStrakan (LSE:PSK), Orexo’s exclusive licensing partner for AbstralTM in Europe and North America. The two new approvals mean that AbstralTM has been approved in five European markets including Sweden, the UK and Germany since March of

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