Bill assures patients continue to have access to ZEVALIN(R) and other novel
SEATTLE, Dec. 20 /PRNewswire-FirstCall/ -- New Medicare legislation passed by the House and Senate extends the 2007 reimbursement methodology for radiopharmaceuticals into 2008. The Centers for Medicare and Medicaid Services (CMS) had implemented new hospital outpatient reimbursement rates for 2008 for radiopharmaceuticals like ZEVALIN(R) (Ibritumomab Tiuxetan) below their acquisition costs. The drugs are used to fight relapsed non-Hodgkin's lymphoma, which for some patients can provide additional therapeutic options. The new Medicare legislation will maintain the current methodology for reimbursement of therapeutic radiopharmaceuticals for the first six months of 2008, giving the drugs' manufacturers and CMS time to seek a permanent reimbursement procedure that more accurately reflects hospital costs associated with the therapy.
"We applaud law makers for responding to the concerns of patients and providers regarding these important therapeutic options for treating patients with this deadly disease," said CTI President and CEO James A. Bianco, M.D. "This legislation will maintain the status quo and provide the drug manufacturers the opportunity to work with CMS on developing an equitable methodology for reimbursing therapeutic radiopharmaceuticals."
Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) has signed an agreement to acquire the U.S. marketing, sales and development rights to ZEVALIN from Biogen Idec, Inc., which it expects to close later this month. Until the transaction is closed, ZEVALIN remains a product and trademark of Biogen Idec, Inc.
ZEVALIN(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy. The ZEVALIN therapeutic regimen is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory follicular 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 aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.
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 include risks related to the closing of the acquisition of
ZEVALIN, risks and uncertainties related to the reimbursement rate for
ZEVALIN, and risks and uncertainties 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 Italian law, CTI is under no obligation to (and expressly
disclaims any such obligation to) update or alter its forward-looking
statements whether as a result of new information, future events, or
|SOURCE Cell Therapeutics, Inc.|
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