Date: 2017-10-18
Type of information: Development agreement
Compound: pegunigalsidase alfa (PRX-102 - alpha-galactosidase-A)
Company: Protalix BioTherapeutics (Israel) Chiesi Farmaceutici (Italy)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: development - commercialisation
Action mechanism:
- enzyme replacement therapy. Pegunigalsidase alfa is a PEGylated, chemically-modified version of the recombinant alpha-galactosidase-A enzyme, in which the protein sub-units are covalently bound via chemical cross-linking using PEG chains, resulting in a longer active and stable molecule compared to currently available enzyme replacement therapies (ERTs).
Disease: Fabry disease
Details:
- • On October 18, 2017, Protalix BioTherapeutics announced an Ex-US license and collaboration agreement with Chiesi Farmaceutici S.p.A., or Chiesi, for pegunigalsidase alfa, or PRX-102, the company’s chemically modified version of the recombinant protein alpha-Galactosidase-A protein that is currently being evaluated in phase III clinical trials for the treatment of Fabry disease. PRX-102 has demonstrated a significantly enhanced circulatory half-life and higher enzyme activity in the target organs affected by Fabry disease when compared to currently available versions of the molecule, and strong positive safety and efficacy data from its completed phase I/II clinical trial.
Financial terms:
- Under the terms of the agreement, Protalix has licensed PRX-102 to Chiesi for all markets outside of the United States, and Protalix will receive an upfront payment of $25 million from Chiesi and additional payments of up to $25 million in development costs, capped at $10 million per year. Protalix is also eligible to receive an additional up to $320 million, in the aggregate, in regulatory and commercial milestone payments, and tiered royalties ranging from 15% to 35% on net sales. Protalix will continue to be the manufacturer of PRX-102 for clinical development purposes and commercial purposes after marketing approvals.
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