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Wednesday, September 20, 2006 5:07:34 PM
http://www.emea.eu.int/pdfs/human/comp/
35763306en.pdf
The EMEA document is a PDF from their orphan committee granting orphan status to "mecasermin rinfibate" (generic name for iPlex / rhIGFBP3 complex) to "ROP Pharma AB". My original post had a typo of ROP Pharma AG, which would have meant a German corporation. "AB" is a code for a Swiss corporation??? Not sure but it's something like that....
I am really curious to know what this is about. Is a new player trying to enter onto scene with their own IP claims? or Is INSM partnered with another firm in EU for ROP indications / trials? I find it hard to believe that INSM is filing with a partner for ROP without a PR or announcement but who knows. I do recall some talk of ROP trials to kick off in EU but I don't remember where I read that. What bothers me is that even if they were kicking of trials in EU with a clinical partner I would think INSM would file for and get Orphan designation in EU themselves (like they have for short stature). Something about this doesn't add up....
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