Protalix BioTherapeutics just entered into a supply and technology transfer agreement with Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health for Uplyso™ (alfataliglicerase), Protalix’ enzyme replacement therapy for the treatment of the rare lysosomal storage disorder Gaucher disease. The tech transfer agreement is intended to transfer 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, high-quality, and cost-effective supply of Uplyso.
Fiocruz has committed to purchase at least approximately $40 million worth of Uplyso during the first two years of the agreement. In subsequent years, Fiocruz is required to purchase at least approximately $40 million worth of Uplyso per year. Additionally, Protalix is not required to complete the final stage of the technology transfer until Fiocruz purchases at least approximately $280 million worth of Uplyso. The technology transfer is expected to take place during a seven-year term, and the agreement may be extended for an additional five-year term as needed to complete the technology transfer. All of the terms of the arrangement, including the minimum annual purchases, will apply during the additional term.
The technology transfer agreement will become effective after the parties receive approval of the agreement by the Brazilian National Institute of Industrial Property, expected to occur in approximately one month. Once the transfer is complete, the government will be the sole source of this treatment option for Gaucher patients in Brazil.
Pfizer, Protalix’ commercialization partner for Uplyso, stands to gain from this deal, too: In March, the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) granted regulatory approval to Pfizer for Uplyso. To facilitate the arrangement with Fiocruz, Pfizer amended its exclusive license and supply agreement and returned commercialization rights in Brazil to Protalix. In exchange, Protalix will pay Pfizer a maximum amount of approximately $12.5 million from Protalix’ net profits generated in Brazil per year of the agreement. During the transition of commercial rights back to Protalix, Pfizer will continue to support Gaucher disease patients in Brazil who are being treated with Uplyso.
“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 who are impacted by this rare disorder,” commented Alexandre Padilha, M.D., Brazil’s Minister of Health.
Uplyso is marketed as Elelyso™ in the U.S. and Israel. Protalix and Pfizer won FDA approval for Elelyso in May 2012.