Protalix BioTherapeutics has entered into a supply and technology transfer agreement with Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health, for UPLYSO (alfataliglicerase), the company's proprietary enzyme replacement therapy for Gaucher disease. Gaucher disease is a rare lysosomal storage disorder that affects approximately 10,000 people worldwide.
The technology transfer is expected to take place during a seven-year term and transfers to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, cost-effective supply of UPLYSO. Fiocruz is required to purchase approximately $40 million worth of UPLYSO per year. Protalix is not required to complete the final stage of the technology transfer until Fiocruz purchases approximately $280 million worth of UPLYSO. The agreement may be extended for an additional five-year term, as needed, to complete the technology transfer.
"Through this collaboration, we are able to strengthen our technological and industrial capabilities in the area of biologics manufacturing and improve the health of Brazilian citizens impacted by this rare disorder," said Dr. Alexandre Padilha, Brazil's minister of health.
In March 2013, the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) granted regulatory approval to Pfizer for UPLYSO for the long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease.