Tuesday, October 30, 2007 4:35:16 PM
Yep, your right (of course 
). In hinsight, my comment was not very usefull there. Lev looks definetly in pole position, However Pharming seems to have a few opportunities to break orphan, if I did my homework well
http://www.fda.gov/orphan/oda.htm provides some leadway:
"...PROTECTION FOR DRUGS FOR RARE DISEASES OR CONDITIONS
SEC. 527 [360cc]. (a) Except as provided in subsection (b), if the Secretary--- ...."
and then after that read subsection b.
My free interpretation is that if the constant supply of product by Lev is questioned by the FDA (for one reason or the other), the FDA could grant Pharming a license as well.
There is also an interesting FDA page on Orphan Drug Regulations, which you probably know much better than I do:
http://www.fda.gov/orphan/odreg.htm
It seems that if it can be proven that the product of Pharming is either of a higher quality (more pure), less prone to possible contamination, or otherwise safer in use, this could be a reason to declare Pharmings product clinical superior and grant a subsequent license to Pharming.
I don't know what Pharming will do, but I suppose it will be along these lines. I am not sure whether the difference in post translation modifications of both products will be enough to declare them non equivalent for the purpose of the orphan designation act. Probably not.
Regards,
Elmono
). In hinsight, my comment was not very usefull there. Lev looks definetly in pole position, However Pharming seems to have a few opportunities to break orphan, if I did my homework well http://www.fda.gov/orphan/oda.htm provides some leadway:
"...PROTECTION FOR DRUGS FOR RARE DISEASES OR CONDITIONS
SEC. 527 [360cc]. (a) Except as provided in subsection (b), if the Secretary--- ...."
and then after that read subsection b.
My free interpretation is that if the constant supply of product by Lev is questioned by the FDA (for one reason or the other), the FDA could grant Pharming a license as well.
There is also an interesting FDA page on Orphan Drug Regulations, which you probably know much better than I do:
http://www.fda.gov/orphan/odreg.htm
It seems that if it can be proven that the product of Pharming is either of a higher quality (more pure), less prone to possible contamination, or otherwise safer in use, this could be a reason to declare Pharmings product clinical superior and grant a subsequent license to Pharming.
I don't know what Pharming will do, but I suppose it will be along these lines. I am not sure whether the difference in post translation modifications of both products will be enough to declare them non equivalent for the purpose of the orphan designation act. Probably not.
Regards,
Elmono
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