18-Month Extension of Reimbursement Rates for Radioimmunotherapies Becomes Law After Congressional Override of Presidential Veto
The bill was originally passed by the U.S. House of Representatives onJune 24, 2008 and by the U.S. Senate on July 9, 2008. Last December, Congressfroze reimbursement rates at the 2007 level for six months after the Centersfor Medicare & Medicaid Services (CMS) released rates for 2008 that were lowerthan the acquisition cost for radioimmunotherapies.
Manufacturers of radioimmunotherapies have been in discussion with CMS ona payment policy that more accurately reflects hospital costs associated withthe 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 Zevalinin late 2007 from Biogen Idec, Inc. Recently CTI reached an agreement withBayer 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 calledradioimmunotherapy and is indicated as part of the Zevalin therapeutic regimenfor treatment of relapsed or refractory, low-grade or follicular B-cellnon-Hodgkin's lymphoma, including patients with rituximab refractoryfollicular NHL. It was approved by the FDA in February of 2002 as the firstradioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex haveoccurred within 24 hours of rituximab infusions. Yttrium-90 Zevalinadministration results in severe and prolonged cytopenias in most patients.Severe cutaneous and mucocutaneous reactions have been reported. The mostserious adverse reactions of the Zevalin therapeutic regimen were primarilyhematologic, including neutropenia, thrombocytopenia, and anemia.Infusion-related toxicities were associated with pre-administration ofrituximab. The risk of hematologic toxicity correlated with the degree of bonemarrow involvement prior to Zevalin therapy. Myelodysplasia or acutemyelogenous leukemia was observed in 2 percent of patients (8 to 34 monthsafter treatment). Zevalin should only be used by health care professionalsqualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com formore information.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed todeveloping an integrated portfolio of oncology products. For additionalinformation, please visit http://www.CellTherapeutics.com.
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This press release includes forward-looking statements that involve anumber of risks and uncertainties, the outcome of which could materiallyand/or adversely affect actual future results. Specifically, the risks anduncertainties that could affect the development of Zevalin include risksassociated with preclinical and clinical developments in the biopharmaceuticalindustry in general and with Zevalin in particular including, withoutlimitation, the potential failure of Zevalin to prove safe and effective fortreatment of non-Hodgkin's lymphoma, determinations by regulatory, patent andadministrative governmental authorities, competitive factors, technologicaldevelopments, costs of developing, producing and selling Zevalin, and the riskfactors listed or described
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