Taliglucerase alfa

CAUTION: taliglucerase alfa is an investigational drug candidate and is not authorized for commercial sale outside of Brazil, Israel or the United States.

Clinical Development

The following clinical studies are ongoing:

• Switchover study (PB-06-002) in pediatric patients switched from imiglucerase to taliglucerase
• Open-Label extension study (PB-06-003) in patients who completed PB-06-001 and PB-06-002
• Expanded Access study (PB-06-004) in ex-U.S. patients affected by the shortage of imiglucerase
• Pediatric extension study (PB-06-006) in naive patients under 18 years of age (who completed protocol PB-06-005)

Regulatory Status

Pfizer is Protalix's partner for the worldwide development and commercialization of taliglucerase alfa in all territories excluding Israel, where Protalix has retained full rights. Additional regulatory submissions are in process elsewhere throughout the world. Protalix is currently making taliglucerase alfa available on a limited basis to adult Gaucher patients in several ex-U.S. countries under Expanded Access Programs.