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Galena Biopharma, Inc. Message Board

  • pacificinternational40 pacificinternational40 Mar 23, 2013 8:34 PM Flag

    SubSys already has a sublingual fentanyl spray product on the marktet in the US

     

    Do your homework.

    Also, Abstral was apparently previously licensed in the US to a different company. Did you know that?

    Sentiment: Strong Sell

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    • Check out LAZANDA, the nasal fentanyl spray. Sub-lingual is old school

      Sentiment: Strong Sell

    • ez1954@rocketmail.com ez1954 Mar 24, 2013 8:07 AM Flag

      from orexo web-site:

      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 pharmaceutical company, Kyowa Hakko Kirin Co. Ltd. (“KHK”), will acquire the rights to Abstral for Europe and will also acquire Orexo’s interests in the companies’ joint venture business covering the Nordic region (Sweden, Norway, Finland & Denmark). Orexo will acquire all rights to Abstral in the US as from 31 December, 2012.

      Sentiment: Buy

      • 2 Replies to ez1954
      • ez1954@rocketmail.com ez1954 Mar 24, 2013 10:08 AM Flag

        Abstral was approved by the US Food and Drug Administration in 2011. Orexo announced in June 2012 the acquisition of all US rights to Abstral from ProStrakan Group plc as a part of a reconfiguration of the worldwide rights to Abstral. With completion of the current transaction Orexo has secured net cash payments of over SEK 700 million (US$ 110 million) and in addition milestones and royalty payments, as a result of the worldwide reconfiguration of Abstral.

        During the last five months, Orexo has evaluated the optimal path forward for Abstral in the United States. The US market for rapid acting fentanyl products reached US$400 million in 2012. Given the continued success that Abstral achieves in Europe, Orexo wanted to secure a commercial team that could drive Abstral to a similar success in the United States. To attain this, Abstral needed to be commercialized by a dedicated partner with insight into the US pharmaceutical market for treatment of cancer and pain. Market research has documented a substantial unmet patient need for improved treatment of breakthrough cancer pain across oncology centers in the United States.

        “With Galena Biopharma, Orexo has found a very committed partner for Abstral in the United States, who is well positioned to realize the significant potential that exists for Abstral. I have been impressed by the competence, experience and dedication to Abstral from the Galena Biopharma management team” stated Nikolaj Sørensen, President and CEO of Orexo.

        Sentiment: Buy

      • From the Orexo website:

        "In January 2011 Abstral was approved by the U.S. Food and Drug Administration, FDA, and was subsequently launched in April by Orexo’s partner ProStrakan. In February 2011 Abstral was also approved in Canada."

    • Yes, anybody that does real DD knows that. ProStraken launched the drug in the US in just shy of 2 years ago.

 
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