Date: 2013-06-19
Type of information: Collaboration agreement
Compound: Elelyso®/Uplyso® (taliglucerase Alfa - plant-cell expressed form of glucocerebrosidase/alfataliglicerase )
Company: Protalix BioTherapeutics (Israel) Fundação Oswaldo Cruz (Brazil)
Therapeutic area: Rare diseases
Type agreement: collaboration
technology transfer
Action mechanism: enzyme replacement therapy. Elelyso® is the first plant cell-expressed enzyme replacement therapy (ERT) for the treatment of Gaucher disease. It is also the first approved plant cell-expressed drug that is derived from ProCellEx®, the Company's proprietary plant cell-based protein manufacturing system, using genetically engineered carrot cells. Elelyso® is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease. Alfataliglicerase was approved by the Brazilian National Health Surveillance Agency in March 2013 for the long-term treatment of adults with Type I Gaucher disease and in November 2016 for the long-term treatment of children four years of age and above with Type I Gaucher disease.
Disease: Gaucher disease
Details: * On June 19, 2013, Protalix BioTherapeutics 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™, the Company's proprietary enzyme replacement therapy for the treatment of Gaucher disease. 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™. 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.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.
Financial terms: Under the agreement, 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 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 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.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 $12.5 million from the Company's net profits generated in Brazilper 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™.
Latest news: * On December 27, 2016, Protalix BioTherapeutics announced the confirmation of the recent letter of intent to purchase alfataliglicerase to treat Gaucher patients in Brazil by the Brazilian Ministry of Health. The Brazilian Ministry’s order consists of a number of shipments during 2017 for a total of approximately $24.3 million. Shipments are to start in mid-2017 and continue through the end of the year, in increasing volumes. The size of the final shipment of this order represents annual revenues of approximately $42 million. * On December 14, 2016, Protalix BioTherapeutics announced that the Company received a letter from Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health, detailing intended purchases by the Brazilian Ministry of alfataliglicerase to treat Gaucher patients in Brazil. The letter requests three shipments of alfataliglicerase; the first shipment to be made in the middle of 2017, and the last at the end of 2017. The Company estimates total revenues from these shipments to be approximately $24 million in aggregate.
* On February 6, 2014, Protalix BioTherapeutics has announced that the Brazilian National Institute of Industrial Property (INPI) has approved the Company's previously-announced 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). Protalix has announced the execution of the supply and technology transfer agreement on June 19, 2013, and receipt of the approval results in the final effectiveness of the agreement as of January 23, 2014. The Company has already completed the first shipment of the drug to Brazil under the agreement.
