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CTI Enters Into Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data for Potential U.S. Supplemental Marketing Application
Date:6/17/2008

chering Pharma AG, who has exclusive rights to Zevalin in all countries of the world except the U.S. CTI has now entered into an agreement with Bayer Schering Pharma to get access to this data. Under the terms of the agreement, CTI will make an initial payment to Bayer Schering Pharma with an additional payment upon FDA approval of a sBLA for Zevalin based on the FIT trial results. CTI also will pay Bayer royalties on net product sales up to a specified aggregate amount.

"We believe that gaining access to these important Zevalin trial data and regulatory documents will allow for the potential to expand the label in the U.S. to include consolidation of first-line therapy, as Bayer Schering Pharma did in Europe, and may give more patients access to the potential benefits of Zevalin," said James A. Bianco, M.D., President and CEO of Cell Therapeutics. "We are pleased with Bayer's willingness to support our efforts to potentially broaden U.S. patient access to this important therapeutic, and delighted to be working with such a talented group of dedicated healthcare professionals."

Cell Therapeutics has requested a meeting with the Food and Drug Administration (FDA) to discuss expanding the label for Zevalin in the U.S. to include consolidation following first-line treatment of follicular lymphoma based on the FIT trial data. If approved, this new indication has the potential to increase the market for Zevalin in the U.S.

About the Phase III First-line Indolent (FIT) Trial

The multinational, randomized phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of Zevalin in patients with CD20-positive follicular lymphoma who had achieved a partial remission or a complete remission after receiving standard first-line chemotherapy regimens. The FIT trial results were presented in one oral and two poster presentations at the American Society of Hematology (ASH) conference in December 2007. The FIT trial demons
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SOURCE Cell Therapeutics, Inc.
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