The sales of Elelyso for the treatment of Gaucher disease have increased significantly so far this year, Protalix BioTherapeutics announced in a press release.
Protalix BioTherapeutics is an Israel-based pharmaceutical company that develops plant cell-based medicines. Elelyso (taliglucerase alfa), a plant-based enzyme, has been widely used as an intravenous enzyme replacement therapy (ERT) for the treatment of Gaucher disease.
Elelyso, also known as Uplyso (alfataliglicerase) in Latin America, was first approved in 2012 by the U.S. Food and Drug Administration (FDA) for adults with Type 1 Gaucher disease, and in 2014 for pediatric use. Many other countries have also approved the drug for Gaucher disease. Substantial data from several clinical trials supports Elelyso’s benefit for Gaucher disease patients.
The company previously announced that it had received a formal purchase order of $24.3 million for Elelyso from Fundação Oswaldo Cruz (Fiocruz), part of the Brazilian Ministry of Health.
In a recent conference “Mude Perspectivas. Gaucher” (“Change Perspectives in Gaucher”), held in Rio de Janeiro, Brazil, Fiocruz officials and other representatives from the Brazilian Ministry of Health said they are strongly committed to the Gaucher community, and announced the adoption of the CONITEC (National Committee for Technology) recommendation to treat all Gaucher patients ages 4 and older with Elelyso.
The protocol will be published in the Gazette after the Brazilian Health Minister signs it.
Protalix also said that its manufacturing activities have increased substantially to meet the $24.3 million of product demand, and anticipating expected future orders. The company also said it is planning to ship around $6 million of Elelyso from the $24.3 million request in or around June. Additional shipments are planned for September and December.
Gaucher disease is a rare autosomal and recessive genetic disease caused by mutations in the GBA1 gene, which in turn leads to the decrease of the activity of the enzyme glucocerebrosidase (GCase).
Type 1 Gaucher disease (GD1), which affects most patients (90 percent in Europe and the U.S., but fewer in other regions), is characterized by effects on the viscera, with onset at approximately age 20. GD1 can limit quality of life and is associated with significant morbidity, but is rarely life-threatening.
