Replies to post #141185 on Biotech Values

[jq1234]

I actually agree with "good chance" statement, I was just more conservative in my own statement.

In granting Vpriv's EU exclusivity, one of the key items is

Significant benefit over existing treatments

The COMP concluded that the claim of a significant benefit of Vpriv over Cerezyme is justified on the
basis of its potential major contribution to patient care in light of the current unsatisfactory supply
situation for Cerezyme. For patients diagnosed with type 1 Gaucher disease, Vpriv can represent an
alternative treatment to Cerezyme, should the supply problems that are occurring with this medicine
continue or happen again in the future.

Thus Cerezyme shortage played major role in Vpriv getting exclusivity. This is no longer true, shouldn't be reason for preventing new treatment into the market, so it is quite possible it is overturned now IMO.

[genisi]

The very obvious claim would be that there's still a shortage of supply in EU.
How about another claim - Vpriv's orphan marketing exclusivity may not be relevant to Protalix' drug because it refers to 'the same drug or biologic' and Elelyso isn't a biosimilar nor biogeneric version to Shire's drug.