Protalix BioTherapeutics, Inc. has announced that it has entered into a supply and technology transfer agreement with Fundação Oswaldo Cruz (commonly referred to as Fiocruz), an arm of the Brazilian Ministry of Health for UPLYSO™ (alfataliglicerase), the Company's proprietary enzyme replacement therapy for the treatment of 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 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.
Under the agreement, Fiocruz has committed to purchase at least approximately US$40 million worth of UPLYSO during the first two years of the agreement.
In subsequent years, Fiocruz is required to purchase at least approximately US$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 US$280 million worth of UPLYSO.
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.
"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 BioTherapeutics' President and Chief Executive Officer.
Dr. Aviezer continued, "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."
The technology transfer agreement becomes effective after the parties receive approval of the agreement by the Brazilian National Institute of Industrial Property, which is expected to occur in approximately one month.
During the technology transfer period, Fiocruz will apply for its own registration of UPLYSO with the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) and continue to make the product available.
Once the technology transfer is complete, the government will be the sole source of this important treatment option for Gaucher patients in Brazil.
"It is an honor to announce this agreement with Protalix for the supply and production of UPLYSO in Brazil," commented Dr. Alexandre Padilha, Brazil's Minister of Health. "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 (ANVISA, Agencia Nacional de Vigilancia Sanitaria) 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, the Company'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 Company will pay Pfizer a maximum amount of approximately US$12.5 million from the Company's net profits generated in Brazil per year of the agreement.
During the transition of commercial rights back to the Company, Pfizer will continue to support Gaucher disease patients in Brazil who are being treated with UPLYSO.
The Company will pay a fee equal to 5% of the net proceeds generated in Brazil to its agent for services provided in assisting the Company to complete the agreement.
UPLYSO is marketed as ELELYSO™ in the United States and Israel.