Cell Therapeutics vor Tounaround?
Das ist eine Wette auf nicht Insolvenz!
Vorsicht Totalverlust möglich!!
Gruss Macos
May Accelerate First-line Launch by Four Months
SEATTLE, Dec. 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the approval of the Zevalin sBLA. If approved, Zevalin would be the first radioimmunotherapy available to patients as first-line consolidation therapy. It is estimated that there would be approximately 18,000 additional patients that currently receive first-line treatment which would potentially be eligible to use Zevalin under the proposed expanded label.
CTI and Spectrum Pharmaceuticals, Inc. entered into an agreement to form a 50/50 owned joint venture, RIT Oncology LLC, on November 26, 2008 to commercialize and develop ZEVALIN in the United States and expects the transaction will close in early December, 2008. CTI initially acquired the US rights to Zevalin from Biogen Idec in December 2007. CTI gained access to the First-line Indolent Trial (FIT) data through an agreement with Bayer Schering Pharma AG, Germany who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe.
"We are pleased that the FDA, by granting the application priority review status, acknowledges that the use of Zevalin in the first-line consolidation setting could represent an important treatment option for follicular B-cell non-Hodgkin's lymphoma patients," said James A. Bianco, M.D., CEO of Cell Therapeutics. "In addition to shortening the timeframe for FDA review from 10 months to 6 months, it would also enable physicians to get this drug to those who may benefit from it sooner. If approved, it also pushes up our anticipated timeline for commercial launch for first-line indication by 4 months which should result in a substantial increase to our revenue forecast in 2009."
Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.
About First-Line Consolidation Therapy
Consolidation therapy is a treatment given after initial induction therapy and is aimed at improving the quality of the patient response by further diminishing the number of cancer cells with the goal of extending the response duration.
About the Phase III First-line Indolent Trial (FIT)
The multinational, randomized phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of Zevalin in 414 patients with CD20-positive follicular non-Hodgkin's lymphoma who had achieved a partial response or a complete response after receiving standard first-line chemotherapy regimens. The FIT trial results were presented for the first time in one oral and three poster presentations at the American Society of Hematology (ASH) conference in December 2007. The FIT trial demonstrated that when used as a first-line consolidation therapy for patients with follicular non-Hodgkin's lymphoma, Zevalin significantly improved the median progression-free survival time from 13 months (control arm) to 37 months (Zevalin arm) (p<0.0001).
The primary investigators of the study concluded that Zevalin consolidation of first remission in advanced stage follicular non-Hodgkin's lymphoma is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin's use in approved indications. Zevalin-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent of patients. Nonhematologic toxicities were 24 percent Grade 3, 5 percent Grade 4, and Grade 3/4 infection was 8 percent.
About Zevalin(R)
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. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. 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 (Rituxan(R)) 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 Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
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.celltherapeutics.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 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 for Zevalin FIT data to be acceptable to the FDA for this expanded indication or any other indication, the determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin, whether the new Joint Venture with Spectrum is completed and the ability of CTI to continue to raise capital to fund its operations. There is also a risk that even if label expansion of Zevalin is approved, it may not result in a significant market increase for the drug due to the presence of other treatment options, failure to gain market acceptance and other factors. 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.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
http://www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T : 206.272.4347
F : 206.272.4434
E: invest@ctiseattle.com
http://www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
Web site: http://www.celltherapeutics.com
http://www.zevalin.com
http://www.prnewswire.com
CTI Fact Sheet (201K PDF)
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4. SEC Filings
5. Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug
11/11/2008
SEATTLE, Nov 11, 2008 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778) for patients with advanced, relapsed aggressive non-Hodgkin's lymphoma (NHL) based on a preliminary intent to treat efficacy analysis. Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (CR/uCR+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). CR/uCR and ORR were determined by an independent assessment panel that was blinded to the treatment assignments. The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised. Seventy-four percent of patients discontinued therapy for disease progression or death, the majority of which were in the standard chemotherapy control arm.
CTI plans to submit complete study data for presentation at a major scientific conference. CTI also intends to request a pre-NDA meeting with the FDA and expects to begin submission of a rolling New Drug Application (NDA) to the FDA in early 2009.
"This positive phase III study is validation of Cell Therapeutics Inc.'s capabilities in acquiring attractive drug candidates, and designing and implementing a successful phase III trial," said James A. Bianco, M.D., CEO of Cell Therapeutics. "These data are consistent with the extensive experience with pixantrone in our phase I and phase II studies and demonstrate the ability to offer patients with advanced, relapsed NHL the potential to obtain a clinically meaningful response like a complete remission, despite having failed multiple other courses of chemotherapy or immuno-chemotherapy."
The EXTEND clinical trial is a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was conducted at 130 sites in 17 countries. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial was designed to examine the complete remission (CR) or unconfirmed complete remission (uCR) rate, overall survival (OS) and progression-free survival (PFS). The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication.
CTI intends to further evaluate additional details of the study and will provide complete safety and progression-free survival information comparing treatment assignments which is currently being assembled for analysis.
Cell Therapeutics will be presenting at the Rodman & Renshaw Healthcare Conference on November 11, 2008 at 10:45 am Eastern time and a webcast will be available at http://www.celltherapeutics.com.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
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.celltherapeutics.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 development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the results of complete safety and progression free survival information for pixantrone which is still being assembled, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, determination the FDA that the PIX301 trial is insufficient to support an NDA filing, the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, 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.
Media Contact:
Dan Eramian T: 206.272.4343 C: 206.854.1200 E: media@ctiseattle.com http://www.CellTherapeutics.com/press_room
Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: invest@ctiseattle.com http://www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
Read at BioSpace.com
Read at Reuters
Mailand keine Lust auf handel heute????
- XYOTAX wird für die Indikation PS2-Erstlinientherapie bei nicht-kleinzelligem Lungenkarzinom geprüft
Cell Therapeutics, Inc. (CTI) (Nasdaq und MTA: CTIC) meldete heute die Einreichung eines Zulassungsantrags (MAA) bei der Europäischen Arzneimittelagentur (EMEA) für XYOTAX(TM) (Paclitaxel-Poliglumex, CT-2103) als Erstlinienbehandlung von Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC), die einen ECOG (Eastern Cooperative Oncology Group)-Performancestatus 2 (PS2) aufweisen. Der Antrag basiert auf einer positiven Stellungnahme, die CTI von der zuständigen Arbeitsgruppe (Scientific Advice Working Party, SAWP) der EMEA erhalten hat. Die SWAP erklärte sich bereit, den Antrag aufgrund der vorliegenden Ergebnisse der klinischen Studien der Phase III zu XYOTAX, die unter dem Namen STELLAR-Studien bekannt sind, zu prüfen.
In der STELLAR-4-Studie fand sich für XYOTAX als Einzelwirkstoff eine mit der von Gemcitabin bzw. Vinorelbin vergleichbare Überlebensrate bei Erstlinien-Patienten. Mit Ausnahme der Neuropathie, die bekannterweise im Zusammenhang mit einer Taxan-Therapie auftreten kann, zeigte sich eine signifikante Senkung von mehreren klinisch bedeutsamen toxischen Effekten, wie schweren Neutropenien und Infektionen, und in der Notwendigkeit von Transfusionen und der Unterstützung mit hämatopoetischem Wachstumsfaktor. Zusätzlich zur verbesserten Verträglichkeit bietet XYOTAX eine im Vergleich zu derzeit üblichen Behandlungen angenehmere Verabreichungsweise und eine Senkung der Gesamtinanspruchnahme von medizinischen Leistungen im Vergleich zu Gemcitabin bzw. Vinorelbin.
Der Antrag wird Ende März offiziell hinsichtlich Validierung geprüft. Mit erfolgter Validierung beginnt der Zulassungsprüfungsprozess, der in der Regel 15 bis 18 Monate in Anspruch nimmt.
"Dies ist ein wichtiger Meilenstein für CTI, der unser Engagement für die Bereitstellung von XYOTAX für diese nicht ausreichend versorgte Patientengruppe deutlich macht. Derzeit gibt es keine zugelassenen Erstlinienbehandlungen für PS2-Patienten mit nicht-kleinzelligem Lungenkarzinom. Bei der Behandlung von Patienten, die eine durchschnittliche Lebenserwartung von nur sechs Monaten haben können, zählt jeder Tag. Deshalb sind Lebensqualität und weniger Zeit in der Arztpraxis oder im Krankenhaus wichtige Vorteile für diese Patienten", so James A. Bianco, M.D., Präsident und CEO von CTI. "Wir sind allen, die die Einreichung des Antrags möglich gemacht haben, sehr verbunden, insbesondere den Prüfärzten und den Patienten, die an den klinischen Studien teilgenommen haben."
CTI führt auch eine laufende klinische Studie der Phase III in Zusammenarbeit mit der Gynecologic Oncology Group (GOG) durch, in der XYOTAX als monatliche Erhaltungstherapie bei Ovarialkarzinom untersucht wird.
Informationen zu Lungenkrebs
Lungenkrebs ist weltweit die häufigste Krebsform. Das nicht-kleinzellige Lungenkarzinom (NSCLC) macht 80 Prozent aller Lungenkrebsfälle aus. Innerhalb der Population von NSCLC-Patienten, bei denen eine Chemotherapie erforderlich ist, stellen die PS2-Patients, die rund 25 Prozent dieser Gruppe ausmachen, eine Population mit besonderen Erfordernissen dar, da sich bei diesen unter zytotoxischer Chemotherapie und gezielten Wirkstoffen niedrige Überlebensraten finden. Die PS2-Patienten stellen eine Untergruppe von Patienten dar, die gehfähig sind und sich selbst versorgen können, die aber nicht in der Lage sind zu arbeiten, obwohl sie über 50 Prozent der Stunden, die sie wach sind, etwas unternehmen. Derzeit gibt es keine zugelassenen Medikamente zur Behandlung von PS2-Patienten mit fortgeschrittenem NSCLC.
Lungenkrebs ist weiterhin die für die meisten Todesopfer verantwortliche Krebsform in Europa. Lungenkrebs macht in Europa über 13 Prozent aller Krebsfälle aus und führte 2000 zu fast 350.000 Todesfällen.
Informationen zu XYOTAX(TM)
XYOTAX(TM) (Paclitaxel-Poliglumex, CT-2103) ist ein in der Erforschung befindliches, biologisch verbessertes Chemotherapeutikum, das Paclitaxel, den in Taxol(R) enthaltenen Wirkstoff, mit einem biologisch abbaubaren Polyglutamat-Polymer verbindet, was zu einem neuen chemischen Produkt führt. Solange die Bindung an das Polymer besteht, ist das Chemotherapeutikum unwirksam, wodurch möglicherweise dem normalen Gewebe hohe Konzentrationen des ungebundenen, wirksamen Chemotherapeutikums und die damit verbundenen toxischen Wirkungen erspart bleiben. Blutgefässe in Tumorgewebe sind im Gegensatz zu Blutgefässen in normalem Gewebe für Moleküle wie Polyglutamat durchlässig. Präklinische Studien legen nahe, dass die Verteilung von XYOTAX aufgrund der durchlässigen Blutgefässe bevorzugt zu Tumoren hin erfolgt, wo es im Tumorbett eingelagert wird und somit die lokale Einbringung signifikant höherer Chemotherapeutikadosen im Tumor ermöglicht, als dies mit der Standarddarreichungsform von Paclitaxel möglich ist. Nach Aufnahme in die Tumorzelle wird das Proteinpolymer durch Enzyme abgebaut, wodurch Paclitaxel als Chemotherapeutikum freigesetzt wird. Präklinische und klinische Studien belegen, dass Östrogen möglicherweise den XYOTAX-Abbau in Lungenkrebszellen beeinflusst. Dies könnte zu einer verbesserten Freisetzung von Paclitaxel und Wirksamkeit bei Frauen mit Lungenkrebs im Vergleich zu Standardtherapien führen.
Informationen zu den STELLAR-Studien
Die im Jahr 2005 abgeschlossenen STELLAR-Studien gehörten zu den grössten randomisierten Phase-III-Studien sowohl bei Zweitlinien-NSCLC-Patienten als auch bei Erstlinien-PS2-NSCLC-Patienten. STELLAR 2 untersuchte XYOTAX im Vergleich zu Docetaxel als mögliche Zweitlinienbehandlung von NSCLC-Patienten. STELLAR 3 untersuchte Carboplatin in Kombination mit XYOTAX oder Paclitaxel als mögliche Erstlinienbehandlung von PS2-Patienten mit NSCLC. STELLAR 4 untersuchte XYOTAX im Vergleich zu Gemcitabin bzw. Vinorelbin als mögliche Erstlinienbehandlung von PS2-Patienten mit NSCLC.
Informationen zu Cell Therapeutics, Inc.
CTI ist ein biopharmazeutisches Unternehmen mit Firmensitz in Seattle, das sich der Entwicklung eines ganzheitlichen Portfolios onkologischer Produkte verschrieben hat, die die Behandlungsmöglichkeiten von Krebs verbessern sollen. Weitere Informationen finden Sie unter http://www.cticseattle.com.
Diese Pressemitteilung enthält zukunftsweisende Aussagen, die eine Reihe von Risiken und Unwägbarkeiten beinhalten, die sich wesentlich und/oder nachteilig auf tatsächliche zukünftige Ergebnisse auswirken könnten. Insbesondere gehören zu den Risiken und Unwägbarkeiten, die die Entwicklung von XYOTAX negativ beeinflussen könnten, Risiken in Zusammenhang mit den präklinischen und klinischen Entwicklungen in der biopharmazeutischen Industrie im Allgemeinen und mit XYOTAX im Besonderen, u.a. die Risiken, dass der Zulassungsantrag für XYOTAX von der Aufsichtsbehörde EMEA nicht angenommen wird oder dass XYOTAX letztlich die Zulassung für Europa nicht erhält sowie Entscheidungen von Zulassungs-, Patent- und staatlichen Verwaltungsbehörden, Wettbewerbsfaktoren, technologische Entwicklungen, Entwicklungskosten, Herstellung und Verkauf von XYOTAX in den verschiedenen Ländern in Europa sowie weitere Risikofaktoren, die von Zeit zu Zeit in den bei der Securities and Exchange Commission eingereichten Unterlagen des Unternehmens aufgelistet bzw. beschrieben sind. Dazu gehören u.a. die zuletzt auf den Formularen 10-K, 8-K und 10-Q vom Unternehmen eingereichten Angaben. Abgesehen von möglichen Anforderungen im Rahmen des italienische Rechts beabsichtigt CTI nicht, seine zukunftsweisenden Aussagen auf den neuesten Stand zu bringen oder zu ändern, sei es aufgrund neuer Informationen, zukünftiger Ereignisse oder aus sonstigen Gründen.
Ansprechpartner für die Medien:
Lindsey Jesch
T: +1-206-272-4347
Susan Callahan
T: +1-206-272-4472
Dan Eramian
T: +1-206-272-4343
M: +1-206-854-1200
E: media@ctiseattle.com
http://www.cticseattle.com/media.htm
Ansprechpartner für Investoren:
Leah Grant
T: +1-206-282-7100
F: +1-206-272-4434
E: invest@ctiseattle.com
http://www.cticseattle.com/investors.htmWebseite: http://www.cticseattle.com
http://www.celltherapeutics.com/pdf/RIT_OncLLC.pdf
gruss macos
Tuesday December 16, 1:30 am ET
SEATTLE, Dec. 16 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc.(CTI) (Nasdaq and MTA: CTIC) announced today they have closed the transaction with Spectrum Pharmaceuticals, Inc. to form a 50/50 owned joint venture, RIT Oncology LLC (LLC), to commercialize and develop Zevalin® ([90Y]-ibritumomab tiuxetan) in the United States. In connection with the closing, Cell Therapeutics received an initial payment of $7.5 million and will receive an additional $7.5 million in early January. The Company may earn an additional $15 million in product sales milestone payments upon achievement of certain revenue targets.
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"RIT Oncology is the first business venture focused on the advancement of radioimmunotherapy (RIT) in the treatment of lymphoma which provides significant resources to help accomplish that mission," said James A. Bianco, M.D., CEO of Cell Therapeutics, Inc. "RIT like Zevalin has been underutilized since its introduction in 2002. With the potential for a first-line indication for consolidation of remission in patients with follicular non-Hodgkin's lymphoma, we will be uniquely positioned to maximize physician and patient access with this potentially valuable treatment option."
Zevalin, a radioimmunotherapeutic, has been exclusively marketed by CTI in the United States since December, 2007 and will now be marketed jointly by CTI and Spectrum through the LLC for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. The U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, a supplemental Biologics License Application (sBLA) filed by CTI for use of Zevalin as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the Zevalin sBLA.
CTI and Spectrum are the sole members of the LLC whose sole purpose is to commercialize Zevalin in the United States. The LLC is governed by a Board of Managers comprised of an equal number of members from both companies. Both parties will equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.
Cell Therapeutics acquired the U.S. rights to develop, market and sell Zevalin from Biogen Idec Inc. (Biogen) in December 2007. As a condition to obtaining the consent of Biogen to convey the Zevalin-related assets to the LLC, among other things, CTI and Biogen have restructured certain milestone payments under the Asset Purchase Agreement dated August 15, 2007 between CTI and Biogen, which milestone payments are the responsibility of the LLC. As part of the milestone restructuring, the LLC has paid to Biogen $2 million and, upon receiving approval from the FDA to expand the labeling for Zevalin with respect to an indolent non-Hodgkin's lymphoma indication prior to 2011, the LLC will pay to Biogen a reduced milestone payment. In connection with the closing, CTI has made a $1.6 million capital contribution to the LLC.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM - News), acted as the exclusive strategic advisor in connection with the transaction.
17.12.2008 11:27
CEP2: AUSSETZUNG/SUSPENSION
DIE FOLGENDE AKTIE IST AB SOFORT AUSGESETZT:
THE FOLLOWING SHARE IS SUSPENDED WITH IMMEDIATE EFFECT:
INSTRUMENT NAME KUERZEL/SHORTCODE ISIN BIS/UNTIL
Cell Therapeutics CEP2 US1509345039 (Nachrichten) BAW/UFN
http://www.nasdaq.com/aspx/...C&symbol=MYGN&symbol=CTIC&selected=CTIC
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http://www.finanznachrichten.de/...h-spectrum-pharmaceuticals-008.htm
08.01.2009 07:31
Cell Therapeutics Receives $7.5 Million Under Joint Venture Agreement With Spectrum Pharmaceuticals
SEATTLE, Jan. 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (News) (CTI) (Nasdaq and MTA: CTIC) announced today that they received $7.5 million pursuant to the joint venture transaction with Spectrum Pharmaceuticals, (News) Inc. to commercialize and develop Zevalin(R) in the United States. In December, the Company received the initial $7.5 million payment in connection with the closing of such transaction. The Company may earn up to an additional $15 million in product sales milestone payments upon achievement of certain revenue targets.
Zevalin, a radioimmunotherapeutic, was exclusively marketed by CTI in the United States since December, 2007 and is now marketed jointly by CTI and Spectrum through RIT Oncology, LLC ("RIT") for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. CTI holds a sale option exercisable from January 15, 2009 through July 15, 2009 in its sole discretion to sell its 50% membership interest in RIT to Spectrum for $18 million. The FDA has accepted for filing and review, and has granted priority review status for a supplemental Biologics License Application (sBLA) for use of Zevalin as consolidation therapy in patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy and expects a decision regarding the sBLA in early April, 2009.
About Zevalin(R)
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, lowgrade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. 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 (Rituxan(R)) 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 Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms - aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
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.celltherapeutics.com/.
This press release includes forward-looking statements that involve a number of risks and uncertainties, including the success of the joint venture in commercializing and developing Zevalin, the ability of the joint venture to accelerate top-line revenues in the near-term, and the ability to integrate Zevalin into Spectrum's commercial, marketing and medical affairs teams, 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 for Zevalin FIT data to be acceptable to the FDA for this expanded indication or any other indication, the ability of CTI to continue to raise capital to fund its operations and the capital requirements of the joint venture, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin. There is also a risk that even if label expansion of Zevalin is approved, it may not result in a significant market increase for the drug due to the presence of other treatment options, failure to gain market acceptance and other factors. You should also review the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI'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.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: media@ctiseattle.com http://www.celltherapeutics.com/press_room Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: invest@ctiseattle.com http://www.celltherapeutics.com/investors
notiert unter Cash und nen Guten Deal mit allergan zwecks Eoquin in der Tasche. 41 mio Upfront und bis zu 300 mio an Meilensteinen. hat jetzt ungefähr 70 mio Cash und hat ne MK von ca. 50 mio.
27.01.2009 07:31
Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
SEATTLE, Jan. 27 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) (Nasdaq and MTA: CTIC) announced today that after communication with the Food and Drug Administration (FDA), CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non-Hodgkin's lymphoma (NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.
"This communication from the FDA is a significant milestone for the Company and for patients with relapsed aggressive NHL as this could be the first drug approved for this unmet medical need," noted James A. Bianco, M.D. Chief Executive Officer of CTI. "With the potential for three drug approvals in 2009 we are on track to meet our objective of cash flow break even in the fourth quarter of this year."
The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.
CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (CR/uCR+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). CR/uCR and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.
The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Cell Therapeutics, Inc. (News)
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.celltherapeutics.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 development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the results of complete safety information, the ability of the company to file a rolling NDA in the first quarter of 2009, determination by the FDA that the PIX301 trial is insufficient to support an NDA filing and that the FDA would grant priority review, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, 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.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: media@ctiseattle.com http://www.celltherapeutics.com/press_room Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: invest@ctiseattle.com http://www.celltherapeutics.com/investors
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Cell Therapeutics says Pixantrone achieves secondary endpoint in end-state study - Update
1/28/2009 3:15 AM ET
Wednesday, biopharmaceutical company Cell Therapeutics, Inc. (CTIC: News ) said that its antitumour agent Pixantrone achieved secondary endpoint of progression-free survival in the end-phase EXTEND trial conducted on advanced, relapsed aggressive non-Hodgkin's lymphoma or NHL patients.
Earlier, Cell Therapeutics announced that the drug-candidate's randomized trial achieved primary endpoint of significant higher rate of confirmed and unconfirmed complete remissions, compared to patients treated with standard chemotherapy. Additionally, the company said Pixantrone treatment considerably increased the overall response rate.
The results were based on the end-phase single-agent trial of pixantrone conducted on 140 patients with relapsed, aggressive non-Hodgkin's lymphoma who had received two or more prior therapies and were sensitive to anthracyclines treatment.
The study followed the special protocol assessment approval from the US Food and Drug Administration in 2004, wherein pixantrone had received fast track designation for NHL.
Commenting on the results, James Bianco, Chief Executive Officer said that Pixantrone, the first agent to show progression-free survival on NHL patients supports a priority review designation on our New Drug Application, or NDA.
On Tuesday, the company announced that it expects to submit a rolling NDA and request for priority review on its antitumour agent for relapsed aggressive NHL in the first quarter of 2009.
The stock closed Tuesday, at $0.1145 on the Nasdaq.
by RTT Staff Writer
For comments and feedback: contact editorial@rttnews.com