Healthcare Industry News: ZEVALIN
News Release - February 12, 2008
Cell Therapeutics, Inc. (CTI) Projects Zevalin(R) Sales of $15 Million With Cash Flow Breakeven for Commercial Operations in 2008CTI to present at 2008 BIO CEO & Investor conference at the Waldorf-Astoria in New York on Tuesday, February 12 at 1:15 PM (Eastern)
NEW YORK, Feb. 12 (HSMN NewsFeed) -- BIO CEO & Investor conference -- James A. Bianco, M.D., President and CEO of Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) will present an overview of the Company's sales and marketing strategy intended to grow ZEVALIN® (Ibritumomab Tiuxetan) sales above the $15 million sales figure reported for 2007. CTI completed the acquisition of ZEVALIN from Biogen Idec at the end of 2007.
"It is encouraging to see ZEVALIN U.S. sales stay steady throughout 2007 when compared to 2006 levels considering the lack of any substantial sales, marketing, or medical information effort by its prior owner on behalf of the product in 2007. We believe this steady sales figure provides a stable base from which our commercial group can grow sales for ZEVALIN's currently approved use in relapsed or refractory follicular non-Hodgkin's lymphoma, a market of more than 10,000 patients in the Unites States," noted Bianco.
"With new compelling clinical data, coupled with our focus on making ZEVALIN radioimmunotherapy readily available for medical oncologists to administer to patients in their clinics, we believe a significantly higher response rate is achievable with ZEVALIN over rituximab for relapsed or refractory follicular lymphoma patients following initial therapy and that such results will help grow market share from the current estimated eight percent. This is a very exciting opportunity for CTI and we expect to maximize on this product opportunity for patients and for our shareholders," Bianco continued.
Commercial Team Expansion
CTI expects to have its initial complement of sales, marketing, and medical affairs infrastructure in place by the second quarter of 2008 under the leadership of Vice President of Commercial Operations, Jim Fong. With more than half of its targeted headcount already in place, CTI recently recruited Kenny Crouch as its National Sales Director. Crouch has more than 22 years of experience in sales, including 18 years in the healthcare industry and 11 years in biopharmaceutical management. Most recently, Crouch served as West Sales Director at CV Therapeutics where he commercialized and launched a novel cardiovascular therapy for ischemic heart disease. In addition, Gennyfer Santel, who joined CTI in December 2005, was recently promoted to Director of Marketing where she will be responsible for developing global strategic and tactical brand plans for CTI's products. Santel has more than 15 years of experience in medical communications and planning, most recently as Vice President, Integrated Services at ApotheCom Associates.
Operating Expense Reductions
In addition to ZEVALIN commercial activities, Bianco will outline CTI's plans to focus on preparing marketing applications for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) and pixantrone (BBR 2778).
CTI expects to file a Marketing Authorization Application (MAA) for XYOTAX in Europe in March based on clinical trial data from the STELLAR trials. In addition to the MAA, CTI will prioritize its resources to the GOG212 trial, a clinical trial of XYOTAX in first-line maintenance ovarian cancer being performed by the Gynecologic Oncology Group (GOG). Interim results from this study are expected in the second half of 2009. The clinical trial of XYOTAX in combination with carboplatin in women with pre-menopausal estradiol levels who have first-line non-small cell lung cancer, known as the PGT307 trial, will be limited to U.S. sites only, until either approval of the MAA or until positive results from the GOG212 trial are reported.
Results of the pixantrone phase III clinical trial in aggressive, relapsed non-Hodgkin's lymphoma (NHL), known as the EXTEND or PIX301 trial, are expected in the summer of 2008. Depending on the results of this trial, CTI may begin a rolling New Drug Application (NDA) submission for pixantrone in the second half of the year. CTI has closed enrollment on its other clinical trials of pixantrone, including the RAPID trial, a first-line randomized phase II study of CHOP-R versus CPOP-R in previously untreated aggressive NHL patients, and the PIX303 trial, a study of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have received at least one prior treatment for indolent NHL.
"Based on feedback from both our partner Novartis and from a panel of oncology experts, all agreed the best step for the Company is to focus resources on obtaining XYOTAX and pixantrone approval with existing or completing phase III trials before making additional substantial investments in alternative indications for these products. Combined with reductions in phase III clinical trials costs for XYOTAX and pixantrone, we are projecting net cash operating expenses of $77 million in 2008," Bianco added.
ZEVALIN® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory 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 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 that could affect the marketing and development of ZEVALIN, or the development of XYOTAX and pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with ZEVALIN, XYOTAX, and pixantrone in particular including, without limitation, the potential failure of these product candidates to prove safe and effective for treatment of non-small cell lung cancer, ovarian cancer, and non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling ZEVALIN, XYOTAX, and pixantrone. In addition, we may not be able to achieve the projected financial results, including sales projected for ZEVALIN in 2008. There is no guarantee that we will receive approval from any regulatory agency for any approved use of XYOTAX or pixantrone. If we are able to obtain such approval, we may not be able to successfully market and sell such products. You should also review 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.
Source: Cell Therapeutics
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