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Drug Names(s): Evoltra (EU), clofarabine

Description: An oral formulation of clofarabine is also in development. Please see SAR393590.

Clofarabine is a second-generation, synthetic nucleoside analog that interrupts the metabolism of cancer cells. It is in the same class as fludarabine, cladribine and gemcitabine, all of which are approved oncology drugs. A second generation purine nucleoside analog with antineoplastic activity. Clofarabine is phosphorylated intracellularly to the cytotoxic active 5'-triphosphate metabolite, which inhibits the enzymatic activities of ribonucleotide reductase and DNA polymerase, resulting in inhibition of DNA repair and synthesis of DNA and RNA. This nucleoside analog also disrupts mitochondrial function and membrane integrity, resulting in the release of pre-apoptotic factors, including cytochrome C and apoptotic-inducing factor, which activate apoptosis.

Deal Structure: On December 21, 2004 Genzyme Corporation completed its acquisition of ILEX Oncology. The stock-for-stock transaction was valued at approximately $1 billion.

In March 2001, Ilex paid $1.1 million to enter a definitive agreement to co-develop clofarabine, a nucleoside analog, with Bioenvision, Inc. (Bioenvision). ILEX took the lead role in developing clofarabine in the United States and Canada, where it will have exclusive manufacturing and marketing rights in exchange for an in-licensing fee, milestone payments and royalties. Bioenvision retained the lead role in developing the compound in Europe, where it will have exclusive manufacturing and marketing rights and Ilex will have rights to royalties.

Genzyme now holds the exclusive rights to develop and market Clolar for cancer applications in the United States and Canada. Bioenvision is responsible for developing clofarabine in the rest of the world and will pay royalties to Genzyme on sales of clofarabine outside of the United...See full deal structure in Biomedtracker

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