FDA Approvals of 2012

11 of 39


Drug: Elelyso
Generic molecule: taliglucerase alfa
Company: Pfizer
Approval date: May 1

The scoop: This orphan drug for Gaucher disease dropped into a market that has been owned by Genzyme and its Cerezyme. While not a large market, Genzyme has made money off of it and Pfizer and partner Protalix ($PLX) believe that they can as well. In the timing-is-everything sphere, it got to the market when Genzyme was only beginning to recover from several years of supply disruptions tied to a plant that had to be closed. Capitalizing on that, Pfizer not only priced Elelyso at a 25% discount to its competitor, it said it was setting up a system that would "endeavor" to maintain a 24-month supply, a clear dig at the Sanofi ($SNY) unit's problems. Israel's Protalix heralded the approval as an endorsement of its plant cell-based manufacturing system. Elelyso is made from carrot cells rather than the more complex mammalian cell-based system that Genzyme uses.