On May 1, 2012, Pfizer and Protalix BioTherapeutics announced that the U.S. Food and Drug Administration (FDA) had approved ELELYSO(TM) (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease.

ELELYSO was the first FDA-approved plant cell-based ERT for Gaucher disease. It was also the first approved plant cell-expressed drug that is derived from ProCellEx^(R), Protalix’s proprietary manufacturing system, using genetically engineered carrot cells. ELELYSO(TM) is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.

Supply disruptions of approved ERTs have been affecting those living with Gaucher disease since 2009 in multiple countries including the U.S. To help minimize the possibility of supply disruptions, Pfizer was launching the “Supply Continuity Program,” which endeavor to maintain a continuously restocked 24 months of supply at various stages of production for U.S. patients prescribed ELELYSO.

With the approval of ELELYSO, Pfizer was also introducing Gaucher Personal Support (GPS), a specialized support program for people living with Gaucher disease. Through the GPS program, Pfizer provides an assistance program covering 100 percent of prescription co-pay expenses for eligible patients on ELELYSO who have commercial health insurance. Additionally, Pfizer also provide financial assistance for eligible patients who are uninsured or under-insured where allowed by law.

GPS is a one-stop resource for patient support and specialty pharmacy services for those taking ELELYSO. GPS staffs a dedicated team of health care specialists who are available 24/7 to help Gaucher disease patients and their families with reimbursement assistance, facilitate locating infusion services, and provide ongoing pharmacy support.