Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) announced today that it has entered into a supply and technology transfer agreement with Fundação Oswaldo Cruz (Fiocruz), an arm of Brazil's health ministry, for its Gaucher treatment Uplyso.
The seven year technology transfer deal is worth at least $40 million annually for a total of $280 million, the company said. 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.
Protalix CEO Dr. David Aviezer said, "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. 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."
Brazilian Minister of Health Dr. Alexandre Padilha said, "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.”
In March 2013, the Brazilian National Health Surveillance Agency granted regulatory approval to Pfizer for Uplyso, which is indicated for the long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease.
To facilitate the arrangement with Fiocruz, Protalix's commercialization partner for Uplyso, Pfizer Inc., amended its exclusive license and supply agreement and returned commercialization rights in Brazil to the company. In consideration for the return of these rights, the Protalix will pay Pfizer a maximum amount of $12.5 million from the Company’s net profits generated in Brazil per year of the agreement. During the return of commercial rights back to Protalix, Pfizer will continue to support Gaucher disease patients in Brazil who are being treated with Uplyso.
Uplyso is marketed as Elelyso in the US and Israel.
Gaucher disease is a rare lysosomal storage disorder that affects approximately 10,000 people worldwide.
Published by Globes [online], Israel business news - www.globes-online.com - on June 19, 2013
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