Pfizer's bet on Protalix--and in taking on the temporarily manufacturing-challenged Genzyme in the Gaucher's disease market--is a new-tech risk-tolerance exercise. Positive Phase III results for Uplyso (taliglucerase alfa) announced this week by the Israeli company also bode well for its plant-cell-based manufacturing platform.
The Protalix ProCellEx technology used in producing Uplyso is generally believed to be cheaper than the traditional mammalian technology used by Genzyme in producing Cerezyme. But neither Uplyso nor the ProCellEx system are approved yet.
Motley Fool columnist Brian Orelli notes that the new manufacturing technology makes Protalix "sexy" to investors but it also boosts the risk level. "After all, the FDA could take an additional delay before signing off on the new system," Orelli writes. The regulator delayed that process two weeks ago by asking for additional data on the manufacturing process.
But manufacturing issues can usually be fixed, says Orelli, and are a safer bet than efficacy or safety issues. "The only questions are how long it'll take and at what cost."
Protalix enjoyed early entry into the market via an FDA expanded access action following inventory depletion of the Genzyme drug. The drug shortage occurred when a Genzyme manufacturing plant was shut down for viral decontamination, as reported earlier. Shire's Gaucher candidate, velaglucerase, joins Uplyso in keeping the heat on Genzyme.
- see the Orelli column