Protalix BioTherapeutics enters Gaucher drug Uplyso deal with Brazil's Ministry of Health

Israel-based Protalix BioTherapeutics (TASE:PLX) 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 proprietary enzyme replacement therapy for the treatment of Gaucher disease.

Uplyso will compete with Genzyme’s Cerezyme (imiglucerase for injection) – the leader in the Gaucher disease treatment sector, as well as Vpriv (velaglucerase alfa, from Shire) and Zavesca (miglustat, from Actelion).

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 around $40 million worth of Uplyso during the first two years of the agreement. In subsequent years, Fiocruz is required to purchase at least about $40 million worth of the drug 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 accord 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.