More good news from Shire on its latest clinical results in a phase 3 trial with VPRIV (velaglucerase alfa). This means more bad news for Genzyme's Cerezyme (imiglucerase) and its troubled manufacturing sites.
The phase 3 study (TKT-034) reported in PBR support case that patients on Cerezyme can be safely moved to VPRIV for treatment of type 1 Gaucher's Disease. In addition to good safety and efficacy results, VPRIV also demonstrated a lower antigenicity profile in the 99 patients in this study as compared to Cerezyme. The seroconversion rate with VPRIV was only 1% as compared to 23% against Cerezyme.
The Shire plant in Cambridge has been FDA inspected and approved. Shire received FDA approval for marketing VPRIV on February 26, 2010. Given Genzyme's manufacturing and quality issues, and given the plan by Shire to undercut Genzyme's pricing by 15% means that Shire should be in very good shape to take market share. Analysts have previously projected that Shire and Protalix could take up to 30% of Genzyme's share in this smallish $1.2 B market. Genzyme's Cerezyme is currently the most expensive drug therapy in the world with an estimated cost of $200,000 annually per patient.
Posted by Bruce Lehr March 27th 2010.