Orphan exclusivity regulation has many flexibilities building into it, thus lots of subjectivity under different circumstances. Shire's Vipriv for Gaucher got Orphan exclusivity in EU only after Genzyme Cerezyme manufacture issue caused shortage, otherwise it wouldn't have, thus PLX's Elelyso would have got approved in EU.
Kamada jumps on inhaled Antitrypsin speculation Kamada (KMDA +1.5%) rises as investors anticipate results from a European trial of an inhaled version of Antitrypsin, an AAT treatment. See profile on KMDA's website.The Phase II/III study is scheduled to be completed by year-end.Here's Jefferies Raj Denhoy (as quoted by Bloomberg): “If the trial is successful, and I think there is a pretty good chance for it to be a success, Kamada will have the only inhalable version of the drug on the market."Jefferies estimate: $800M/year globally.
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