Insmed Inc (INSM)

[surf_baron]

re: New production method question...

Buy4long,

I don't thnk anyone addressed your question. We don't know for sure, somone should probably pose question to INSM. But I believe the '414 patent relates to cell culture / fermentation processes to manufacture the proteins. INSM's new "shle-stable" formulation sounds like a lyophylized (freeze dried) version of the product. Chances are the cell culture methods and protein expression techniques (re 414 patent) won't be radically different. The relatively same proteins will be lyopholized at end of process (probably by INSM's fill/finish subcontractor). I don't know for sure but would guess that's what INSM will be delivering, changing cell culture / protein expression techniques and media / host etc. would be a much larger process change and would probably require clinical's to get licensure changes. Fill finish changes can potentially be made with less regulatory hurdles and with stability and equivalency studies only. That's what I figure their doing.

Hope this helps...