Schering and Novartis agree on joint commercialization of novel cancer drug

Schering AG, Germany announced today that, following regulatory approvals, it will co-promote the novel oral angiogenesis inhibitor PTK787/ZK 222584 (PTK/ZK) for all oncology indications together with Novartis Pharma AG in Europe, North America and Japan. This agreement will enable both Schering and Novartis to maximize the compound's full potential.

An initial research collaboration agreement gave Schering exclusive marketing rights in Europe, while Novartis held corresponding rights for North America.

Under the new agreement, Schering and Novartis will join forces in each of the major markets of the world. The value of the agreement for Schering and Novartis is designed to be equal based on the co-promotion terms and territory allocations. Schering will become the lead partner in Europe while Novartis will be the lead partner in North America. The lead partner will bear the larger part of costs and resources, and will thus retain a correspondingly larger percentage of the profits. For Japan, costs and profits will be shared equally by Schering and Novartis. In Latin America, Africa and Australia Schering will exclusively market PTK/ZK. Novartis will exclusively market the product in Asia, excluding Japan. Additional details of the agreement were not disclosed.

"By joining forces in each of the major markets of the world, Schering and Novartis will be able to rapidly and effectively reach the patients who will benefit most from PTK/ZK," said Marc Rubin, MD, member of the Executive Board of Schering AG, responsible for development and oncology. "PTK/ZK has the potential to significantly advance the clinical approach to colorectal cancer, and to provide a meaningful benefit to patients with this devastating disease. It should play an important role in the expansion of our global oncology business."

PTK/ZK is a novel, oral angiogenesis inhibitor designed to target the tumor blood vessels and potentially lymphatic vessels, thus slowing tumor growth and spread. It is currently being co-developed by Schering and Novartis. The efficacy and safety of the substance is currently being evaluated in two clinical Phase III studies in patients with metastatic colorectal cancer (CONFIRM 1 & 2). The enrollment of approximately 2,000 patients in more than 200 centers was completed in 2004. Schering expects first study results in the second quarter of 2005. It is planned to submit the product for registration in the second half of 2005.

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