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Sigma-Tau S.p.A.

Drug Names(s): IV Artesunate

Description: IV Artesunate is a semi-synthetic derivative of the natural product, Artemisinin, from qing hao, the sweet wormwood plant.

Artemisinin is a drug used to treat multi-drug resistant strains of falciparum malaria. The specific mechanism of action of artemisinin is not well understood, and there is ongoing research directed at elucidating it. When the parasite that causes malaria infects a red blood cell, it consumes hemoglobin and liberates free heme, an iron-porphyrin complex. The iron reduces the peroxide bond in artemisinin generating high-valent iron-oxo species, resulting in a cascade of reactions that produce reactive oxygen radicals which damage the parasite leading to its death.

Artemisinin is under early research and testing for treatment of cancer. Artemisinin has a peroxide lactone group in its structure. It is thought that when the peroxide comes into contact with high iron concentrations (common in cancerous cells), the molecule becomes unstable and releases reactive oxygen species. It has been shown to reduce angiogenesis and the expression of vascular endothelial growth factor in some tissue cultures.

Deal Structure: The Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Materiel Development Activity (USAMMDA) initially developed IV Artesunate in response to concerns over the risks of malaria exposure to deployed forces.

In March 2007, WRAIR and USAMMDA announced a new partnership with Sigma-Tau Pharmaceuticals to help finalize the research and development of IV Artesunate for severe malaria. Sigma-Tau will complete the research studies and prepare forsubmission to the U.S. Food and Drug Administration (FDA) for marketing clearance. Under the agreement, Sigma-Tau will be responsible for the commercial development andmanufacturing of IV Artesunate should the FDA approve it.

Alfa Wassermann and Sigma-Tau
In March 2015, Alfa Wassermann and Sigma-Tau signed an agreement to create a new company where each of them will contribute its pharmaceutical business. This industrial partnership will not include Sigma-Tau rare disease business and some financial stakes...See full deal structure in Biomedtracker

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