What a strained meeting this will be with Shire owning the EU space for Gaucher's for the next ten years while all the big players (Sanofi, Pfizer and Shire) make nice and present the scientific facts.
"Just the Facts, mame" - nope, it's politics as usual.
twelvetooth wrote: "Shire owning the EU space for Gaucher's for the next ten years"
Cerezyme approved in EU in 1997. Shire does not own EU space. So Shire's Vpriv orphan status might block Elelyso, but does not block existing drug Cerezyme. So in reality, Vpriv does not have marketing exclusivity in EU.
I think Vpriv should have its orphan status removed in EU. Major reason it got it is because shortage of Cerezyme at the time of approval. So Vpriv had "major benefit" of giving an alternative in case of future shortages.
There is still some hope for a European approval, although we believe the probability is significantly reduced. The Committee for Medicinal Products for Human Use’s (CHMP) negative recommendation is not final, and PLX/PFE plan to request a re-examination of the filing. The EC, who makes the final decision in the next several months, almost always follows CHMP's recommendations, although given the unusual circumstances it is still possible EC could allow Elelyso to be marketed. Although PLX is to have incremental new data shortly from bone morphology studies supporting Elelyso's benefits, we do not believe this will likely convince the EC that Elelyso has clear clinical advantages over Vpriv (necessary for a formal exception to Shire's orphan status). PLX's case could be helped if EC takes a broader view of the need for an additional enzyme on the market, and European patient/physician organizations--who would support having availability of an additional enzyme given historical supply issues-exert more influence during this appeals process. This should not have any negative implications on other territories for Elelyso or on PLX’s underlying technology. CHMP’s positive views on the clinical aspects of the drug further validate regulatory acceptability of PLX’s plant-based production platform, and we do not believe the Shire Orphan issue exists in any other territories. We continue to expect potential Israel approval and a Brazil agreement in H2 2012. Give credit to WellsFargollc06/25/2012.