Protalix in UPLYSO Supply Pact with Brazil

Protalix BioTherapeutics has entered into a supply and technology transfer agreement with Fundacao Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health, for UPLYSO (alfataliglicerase), the company’s enzyme replacement therapy for the treatment of Gaucher disease.
 
The tech transfer will take place during a seven-year term and will provide Fiocruz with the capacity and skills required for the Brazilian government to construct its own manufacturing facility to supply UPLYSO. Fiocruz has agreed to purchase approximately $40 million worth of UPLYSO during the first two years and approximately $40 million each subsequent 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 to complete the transfer.
 
“We are excited to be working with the Brazilian government in its efforts to provide UPLYSO to Gaucher patients in Brazil and to collaborate with Fiocruz regarding our plant cell technology,” said Dr. David Aviezer, Protalix’ president and chief executive officer. “We are encouraged by the recognition of our drug and our technology by both Fiocruz and Brazil’s Ministry of Health, and believe that this agreement will further establish a reliable supply of treatment for patients living with Gaucher disease.”
 
During the technology transfer period, Fiocruz will apply for its own registration of UPLYSO with the Brazilian National Health Surveillance Agency (ANVISA) and continue to make the product available. Once the technology transfer is complete, the government will be the sole source of the product.
 
To facilitate the arrangement with Fiocruz, Protalix’ commercialization partner for UPLYSO, Pfizer, amended its exclusive license and supply agreement and returned commercialization rights in Brazil. Protalix will pay Pfizer approximately $12.5 million from the profits generated in Brazil per year of the agreement.