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August 16, 2007
By: Tim Wright
Editor-in-Chief, Contract Pharma
Cell Therapeutics, Inc. will acquire Zevalin, the first FDA-approved radioimmunotherapy, from Biogen Idec. CTI will be responsible for marketing, sales, and development of the drug in the U.S. The drug will continue to be sold outside the U.S. by Bayer Schering under a previous agreement with Biogen Idec. Zevalin was approved by the FDA in 2002 to treat patients with relapsed indolent non-Hodgkin’s lymphoma (NHL). In 2006, Biogen Idec reported $16.4 million in Zevalin sales in the U.S. Under the terms of the agreement, CTI will pay Biogen Idec $10 million in cash, as much as $20 million more in milestone payments when the product receives approval for a first-line indication in NHL, and royalties on sales. CTI has also agreed to share the cost of certain clinical trials of Zevalin with Bayer Schering. The acquisition is subject to certain closing conditions. “Zevalin is an effective yet underutilized drug with a favorable tolerability profile, producing high rates of complete response coupled with long-term remissions, all following just a single therapeutic dose,” said Jack W. Singer, M.D., chief medical officer of CTI. “We believe the potential cost savings and practice efficiencies compared to standard combination chemotherapy will become increasingly attractive to oncology group practices in the ever-evolving reimbursement environment. We are currently planning to conduct registration-directed trials to expand the label into first-line treatment in both the aggressive and indolent NHL settings,” Dr. Singer noted. “Acquiring Zevalin returns CTI to a select group of biotech companies who market and sell a commercial product in the U.S. We see potential for substantial revenue growth for this product with additional clinical data and increased patient and physician knowledge about its potential in treating patients with NHL,” said James A. Bianco, M.D., president and chief executive officer of CTI. “Importantly, in addition to the untapped revenue potential for Zevalin, it is an excellent complement to pixantrone, which is in phase III trials in similar patient populations. Ensuring this important cancer treatment remains available to patients fits into CTI’s mission of making cancer more treatable.”
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