Replies to post #122715 on Biotech Values

[biomaven0]

Yes, the "same" product could break orphan exclusivity provided they demonstrated clinical superiority on either efficacy or safety.

Here's some discussion by the FDA (in a memo on Rebif) of another path:

There is also a third approach described in the regulations for showing a significant
therapeutic advantage. This requires a demonstration that, in an unusual case where
neither greater effectiveness or safety has been shown, a drug otherwise makes a major
contribution to patient care. This analysis may involve multiple aspects of the drug
product, since the benefit to the patient is likely to be greater convenience or less
discomfort, and the very term "major contribution to patient care" implies a more global
assessment. So, for example, an assessment of the safety or effectiveness of the new
form of the subsequent product might be considered in determining whether the drug
made a major contribution to patient care.

http://www.google.com/url?sa=t&source=web&cd=2&sqi=2&ved=0CCEQFjAB&url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FDrugs%2FDevelopmentApprovalProcess%2FHowDrugsareDevelopedandApproved%2FApprovalApplications%2FTherapeuticBiologicApplications%2Fucm094512.pdf&ei=qwEOToO-O8fw0gHZo-WbDg&usg=AFQjCNH_IVCsbF_2gbGhphZz1Y0csHJ-FA&sig2=QYVen_iK_oEm1VpzEPpQ1Q

[iwfal]

what if one product (same mechanism) had better safety/tolerability or was more convenient[\quote]

If all they had in common was the same MOA then the drug with orphan status would have no more protection than if it had no orphan status. There may some slightly breadth of protection than patent protection but if all it has in common with the orphan drug than the only protection the orphan drug has is patent protection.