For those of you who have knowledge of such things, have you any idea how the GSK's EU patent for exon-51 might affect access to Eteplirsen (if Eteplirsen is granted approval first)? Does it mean that, even if granted approval, it cannot be sold/marketed in the EU?

Thanks.

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It cannot unless Sarepta and GSK/Prosensa enter and agreement. Also, not clear how the fact that it was not tested in the EU plays. It will need to be approved by EMA so you do not pay for treatment. Sarepta would need to apply for approval but only if they have an agreement with GSK/PRosensa since they lots the patent dispute in the EU. I heard Chris talking about thinking to find a partner for the EU market, then the partner would take over the development/approval process in the EU. Nothing clear, just thoughts on their part. It's a good question for that Webminar this week.

Thanks Ofelia. My fear is that it will have to go through the whole regulatory testing process in the EU again (many, many years) to get approval here, even if GSK allow it.

I think that there are cases of drugs approved in the EU (if approved by the FDA) w/o going through testing, based on data accepted by the FDA. This is and orphan disease w/o a treatment, it should be possible if approved by the FDA here. Not sure how they plan to approach the patent problem, i missed his answer yesterday.

lisa burke said:

Thanks Ofelia. My fear is that it will have to go through the whole regulatory testing process in the EU again (many, many years) to get approval here, even if GSK allow it.

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