Protalix BioTherapeutics enters into agreement with Brazilian government for Gaucher’s disease drug

Published: 21-Jun-2013

Amends exclusive licensing and supply agreement with Pfizer to facilitate the technology transfer


Israel’s Protalix BioTherapeutics has entered into a 7-year, US$280m supply and technology transfer agreement with Fundação Oswaldo Cruz (referred to as Fiocruz), an arm of the Brazilian government, for Gaucher’s disease drug Uplyso (alfataliglicerase).

The drug is manufactured and marketed in Israel and the US by Protalix, but is licensed under the name Elelyso in the rest of the world by Pfizer.

Protalix said Pfizer has amended its exclusive supply agreement and returned commercialisation rights in Brazil to the company in order to enter the supply and technology transfer deal with Fiocruz.

In consideration for return of these rights, Protalix will pay Pfizer up to US$12.5m from the company’s net profits generated in Brazil during each year of the agreement.

Under the terms of the agreement with Fiocruz, Protalix will manufacture Uplyso and at the end of a 7-year technology transfer will hand over operation of the plant to Fiocruz to construct its own manufacturing facility and produce a ‘sustainable, high quality, and cost effective supply of Uplyso’.

We believe that this agreement will further establish a reliable supply of treatment for patients living with Gaucher’s disease

Fiocruz will purchase at least US$40m worth of Uplyso during the first two years of the agreement. In subsequent years, the Brazilian government is required to purchase at least US$40m worth of Uplyso each year. Additionally, Protalix is not required to complete the final stage of the technology transfer until Fiocruz purchases at least US$280 million worth of Uplyso.

The agreement may be extended for an additional five years, as needed, to complete the technology transfer.

‘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 David Aviezer, Protalix BioTherapeutics’ President and Chief Executive. ‘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’s disease.’

Once the technology transfer is complete, the Brazilian government will be the sole source of Uplyso in Brazil.

‘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,’ said Alexandre Padilha, Brazil's Minister of Health.

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