Grifols (GRFS -1.6%) says that Aradigm (ARDM.OB) has received shareholder approval for its...


Grifols (GRFS -1.6%) says that Aradigm (ARDM.OB) has received shareholder approval for its license agreement giving GRFS access to Aradigm's proprietary formulations of inhaled ciprofloxacin, which is used for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis. In conjunction with the licensing agreement, GRFS will acquire 35% of Aradigm's common stock at a price per share of $0.124 for a total investment of approximately $26M.

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  • smucelli
    , contributor
    Comments (28) | Send Message
     
    Great post about Aradigm / Grifols by rehdvm2004

     

    The "deal" had to be approved by stockholders. Now the way is clear to have a preclinical sit down with FDA and/or EMEA and get the Phase III study started. INSM achieve only one log bacteria reduction with 28 days of treatment and 28 days rest. That was with a once per day Rx regimen. Pulmoquin is also once per day, but the Phase IIb study showed FOUR logs reduction of bacteria. One log is a count of 10 bacteria. So Pulmoquin was showing a 10,000 fold reduction in the marker bacteria. Grifols made a great choice. It keeps ARDM funded for the Phase III and points to the future for the drug. There will be other studies that come up along the way and I am sure that the CF/Pa market is just a matter of cross-filing the Phase III data from the current study. The regulatory agencies have had so many new inhalational antibiotics of late, that the protocols, diagnostic tests and comparative aspects of clinical data analysis are all algorithms.

     

    ARDM is not known yet, but give it 6 to 18 months!
    16 Jul 2013, 03:06 PM Reply Like
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