Cell Therapeutics, Inc. (CTI) announced that it has agreed to acquire Zevalin (ibritumomab tiuxetan), the first FDA-approved radio-immunotherapy, from Biogen Idec.
CTI will be responsible for marketing, sales, and development of the drug in the United States. The drug will continue to be sold outside the United States by Bayer Schering under an agreement between Biogen Idec and Bayer Schering, a CTI press release stated.
The US Food and Drug Administration (FDA) approved Zevalin in 2002 to treat patients with relapsed indolent non-Hodgkin's lymphoma (NHL). In 2006, Biogen Idec reported $16.4 million in US Zevalin sales.
"Zevalin is an effective yet underutilized drug with a favourable 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," Singer noted.
"Acquiring Zevalin returns CTI to a select group of biotech companies who market and sell a commercial product in the United States. 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 CEO 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."
Under the terms of the agreement, CTI will assume control of US marketing, sales, and development of Zevalin. Upon closing, CTI has agreed to pay Biogen Idec $10 million in cash up front, up to an additional $20 million 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 in the event such trials are undertaken. The acquisition is subject to certain closing conditions, including filings under the Hart-Scott-Rodino Antitrust Improvements Act. CTI was advised on the transaction by CIBC World Markets Corp.
The anticipated acquisition marks the second of two steps CTI has taken to strengthen its product pipeline and re-establish its commercial presence. On July 31, CTI completed the acquisition of Systems Medicine, Inc. (SMi), which provides CTI with worldwide rights to Brostallicin, a late-stage DNA minor groove binding agent with proven anti-tumour activity and a favourable safety profile in more than 200 patients treated to date in clinical trials. Brostallicin is currently in phase II clinical studies. In anticipation of its re-entry into the market with a commercialized product, CTI has plans to hire an industry veteran with strong experience in oncology drug development to lead its commercial operations.