SEATTLE, July 15 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that Congress today passed the Medicare Improvements for Patients and Providers Act of 2008, which includes an 18-month extension of the 2007 reimbursement rate for radioimmunotherapies such as Zevalin(R) (Ibritumomab Tiuxetan), overriding President Bush's veto.
The bill was originally passed by the U.S. House of Representatives on June 24, 2008 and by the U.S. Senate on July 9, 2008. Last December, Congress froze reimbursement rates at the 2007 level for six months after the Centers for Medicare & Medicaid Services (CMS) released rates for 2008 that were lower than the acquisition cost for radioimmunotherapies.
Manufacturers of radioimmunotherapies have been in discussion with CMS on a payment policy that more accurately reflects hospital costs associated with the therapy. These drugs are used to fight relapsed non-Hodgkin's lymphoma (NHL), and can provide some patients with additional therapeutic options.
CTI purchased the U.S. sales, marketing, and development rights to Zevalin in late 2007 from Biogen Idec, Inc. Recently CTI reached an agreement with Bayer Schering Pharma, which has rights to Zevalin outside the United States, for access to pivotal trial data from the First-line Indolent Trial (FIT), which can potentially be used to expand the label in the U.S.
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com for more information.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products. For additional information, please visit http://www.CellTherapeutics.com.
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This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of Zevalin include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with Zevalin in particular
including, without limitation, the potential failure of Zevalin to prove
safe and effective for treatment of non-Hodgkin's lymphoma, determinations
by regulatory, patent and administrative governmental authorities,
competitive factors, technological developments, costs of developing,
producing and selling Zevalin, and the risk factors listed or described
from time to time in the Company's filings with the Securities and Exchange
Commission including, without limitation, the Company's most recent filings
on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does
not intend to update or alter its forward-looking statements whether as a
result of new information, future events, or otherwise.
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|SOURCE Cell Therapeutics, Inc.|
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