Basel, 6 November 2003 - 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.
Preclinical 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."
This release contains certain "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "suggest," "potential," "will," "opportunity" or similar statements, or by express or implied discussions regarding the potential development and commercialization of Gimatecan. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements.
There are no guarantees that the agreement that is the subject of this release will lead to commercialization of Gimatecan or alternative compounds in any market. Any such commercialization can be affected by, among other things, uncertainties relating to product development and clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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