LONDON ¿ Xenova Group plc licensed its topoisomerase inhibitor program for treating solid tumors to Millennium Pharmaceuticals Inc. in a deal that includes an up-front sum of US$11.5 million, research funding of $20 million and milestone and royalty payments.

The partners will split marketing rights, with Millennium taking North America and Xenova taking Europe and the rest of the world.

David Oxlade, CEO of Xenova, told BioWorld International, ¿This is a very important transaction for several different reasons. It is the second major deal in six months and confirms Xenova truly can generate commercially important science from its own resources. It is financially very important and [Millennium has] bought into a development plan, which they want us to take into the clinic.¿

Although full terms were not disclosed, Oxlade said the royalty rate was similar to those typical for a Phase I or Phase II program, not preclinical, as in this case.

Xenova, based in Slough, had considered the program to be at too early a stage to partner. ¿But as a result of data we have presented at various international conferences over the past six to nine months, we¿ve been approached by several major companies, including Millennium. On balance we thought if we could do a deal, why not?¿

The company will continue to carry out development at its own expense during 2002. From the start of 2003 to the end of Phase II trials, Millennium will fund development to be carried out by Xenova. The partners will then consider how to take the program forward, but Millennium will be responsible for development activities in North America, and Xenova for the rest of the world.

The topoisomerase program consists of the three compounds, XR11576, XR5944 and XR11612, all of which are at the preclinical stage. In February 2001 Xenova dropped XR5000, a first-generation topoisomerase compound, after four Phase II trials in different cancers. The compound was administered by injection, and it only started to show efficacy at doses that were not well tolerated. The second-generation compounds involved in the Millennium deal have shown far higher potency in preclinical studies, and one, XR11576, is orally available.

The three compounds are inhibitors of topoisomerase I and II, enzymes that are active at different stages of the cell cycle, and are therefore expected to be more potent than existing agents that target one of the enzymes alone. Preclinical studies indicate the compounds cause DNA damage, thus activating pathways that lead to apoptotic cell death in tumor cells.

In August, Xenova agreed to a deal with an initial value of #75 million (US$109 million) with QLT Inc., of Vancouver, British Columbia, for XR9576, for the prevention of drug resistance in cancer chemotherapy.

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