Novartis Pharma AG has executed a commercialization agreement with Schering AG, Germany, for the investigational agent PTK787, known by Schering AG as ZK222584. PTK787 is an oral angiogenesis inhibitor, which Novartis and Schering AG have been jointly researching and co-developing since 1995.
Under the commercialization agreement, the companies will partner on promotion and further development of the product all oncology indications including metastatic colorectal cancer in all major markets. The value of the agreement to Schering and Novartis is designed to be equal based on the co-promotion terms and territory allocations. Novartis will lead North American co-promotion activities and Schering will lead European co-promotion activities with both companies sharing co-promotion activities equally in Japan. Novartis will exclusively promote the product in Asia (excluding Japan) and Middle East. Schering will exclusively promote PTK787 in Latin America, Africa and Australia.
PTK787 is currently in phase III clinical trials for metastatic colorectal cancer. Initial results are expected in the second quarter of 2005, and filing planned for the second half of 2005. Two phase III trials have enrolled approximately 2,000 patients with metastatic colorectal cancer at more than 200 centres around the world, a Novartis release said.
"This agreement will further optimize the commercialization and future development activities for this potential breakthrough cancer medicine. Our collaboration has enabled us to effectively move PTK787 through clinical trials and now working closely together in the world's major regions should allow us to most effectively reach physicians and patients once the medicine is commercialized," said David Epstein, CEO of Specialty Medicines and president of Novartis Oncology."
In a separate agreement with Schering, Novartis has obtained exclusive rights to develop PTK787 for the treatment of "wet" age-related macular degeneration (AMD). Under the agreement, Novartis will obtain full global and exclusive developmental and commercialization rights to PTK787 in ophthalmics. Novartis will pay an upfront fee, milestone payments and royalties on ophthalmics sales. Additional details of the agreement were not disclosed.
According to the World Health Organization, in 2000 there were almost 940,000 cases of colorectal cancer worldwide, almost 65 per cent of which were in the more developed countries.