Novartis Pharma AG has signed an agreement with Sigma-Tau of Rome, Italy, for the rights to develop and commercialize Gimatecan, a next generation oral topoisomerase I inhibitor in Phase II development for the treatment of common solid tumors.

Pre-clinical data and early clinical results for Gimatecan have shown anti-tumor activity. The data also suggest the compound is well tolerated, with reduced side effects such as diarrhea, which can limit effective dosing for other cytotoxic drugs. Phase II trials are underway in a variety of cancers. The medicine is administered orally, with the potential to further ease cancer patients' burden.

Topoisomerase I inhibitors are an important class of cytotoxic agents used in cancer therapy. By inhibiting an enzyme involved in the DNA replication process, topoisomerase I inhibitors stop a tumor cell from making a copy of its genetic material, thus preventing the cell from dividing.

Novartis will have worldwide rights to Gimatecan, with co-commercialization in Italy. Under the agreement, Sigma-Tau will receive an upfront payment and development milestone payments as well as royalties based on worldwide net sales.

Thomas Ebeling, CEO of Novartis Pharma, said: "Cytotoxics remain a mainstay of cancer therapy and there is an unmet medical need for more effective, easier to administer and less toxic cytotoxic medicines for cancer patients. The early data with Gimatecan provides Novartis with an opportunity to use our considerable expertise in drug development and commercialization to help address this need and to improve the lives of cancer patients."

Dr. Claudio Cavazza, president of Sigma-Tau, said: "We have been investing aggressively in innovation and R&D. We are extremely gratified to witness the first oncology product from this effort yield such promise and to enter into this important partnership with Novartis, an innovative global leader in oncology. This partnership is an affirmation of our strategy and of Sigma-Tau and provides a solid foundation for future cooperation in the development of Gimatecan."