Spectrum Pharma (SPPI) FDA Entscheidung 7.3.08
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| Eröffnet am: | 06.03.08 16:12 | von: MarS | Anzahl Beiträge: | 16 |
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- Das Advisory Committee hat die Zulassung einstimmig befürwortet.
- Das Präparat ist in Europa und Japan bereits zugelassen.
Marktkapitalisierung SPPI : ca. $77 Mio
Cash : $65 Mio
Die Firma verspricht sich von ISO-Vorin ein Umsatzpotential von $200 Mio.
Shortquote: ca. 12% (ist eher niedrig).
SPPI hat als Lizenzgeber von GPC's Satraplatin ebenfalls starke Kursverluste erlitten, und ist noch in der Nähe des Langzeittiefs.
Die Umsätze sind erstaunlich niedrig für den anstehenden Termin, die Aktie ist deutlich nicht im Fokus.
Ich habe mir mal eine kleine Position gegönnt. An fundierten Meinungen zur Zulassungswahrscheinlichkeit bin ich natürlich interessiert.
-- Proprietary Drug Levoleucovorin For Injection (formerly known as ISO-Vorin(TM)), A Novel Folate Analog, Is the First New Oncology Drug Approved By the FDA in 2008 -- Proprietary Brand Names Submitted by Company Currently Under Review by FDA -- LEVOleucovorin Has Been Marketed with Success in Europe and Japan by Wyeth, Sanofi and Others
IRVINE, Calif., Mar 07, 2008 (BUSINESS WIRE) -- Spectrum Pharmaceuticals, Inc.:
Conference Call: Monday, March 10, 2008 @ 4:30pm Eastern/1:30pm
Pacific
Domestic: 866-510-0710
International: 617-597-5378
Passcode: 52089784
Webcast and replays: www.spectrumpharm.com
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.
LEVOleucovorin was reviewed under a full NDA, and included an Oncologic Drug Advisory Committee (ODAC) review. Spectrum anticipates that the drug will be listed without any therapeutically equivalent product in the FDA Orange Book. Drugs without therapeutic equivalents are considered 'single source drugs' which under section 1847A of the Social Security Act generally qualify for a separate reimbursement code with CMS.
"LEVOleucovorin is the first new oncology drug approved by the FDA in 2008, and is the first of what we hope will be many approvals from our pipeline," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Only four of the 17 drugs approved by the FDA in 2007 were new oncology drugs. This approval is the result of dedicated efforts by our experienced team and serves as a validation of our business model. We are focused on building a diversified portfolio of promising late stage drugs, and advancing them through clinical development, regulatory process and commercialization."
In preparation for the commercial launch, last year the Company appointed George Uy, an experienced oncology marketing veteran, as its Vice President of Sales and Marketing. George brings more than 20 years of hands on experience, including the launches of ABRAXANE(R) at Abraxis Bioscience, Inc., and XELODA(R) at Hoffmann-La Roche Inc. In addition, the Company recently appointed Lynne Murphy as Executive Director of Sales. Ms. Murphy has more than 20 years of sales and marketing experience, which include many sales leadership positions with responsibility for the launch of more than 10 products during her tenure at Bayer Healthcare. Ms. Murphy also led a specialty sales force for Amgen, Inc., and launched Aranesp(R) Singleject. Ms. Murphy will be responsible for building and assembling a launch team of experienced oncology sales specialists.
"LEVOleucovorin provides physicians and patients with an important treatment alternative to leucovorin," said Richard A. Bender, M.D., F.A.C.P., Chief Medical Officer of Spectrum Pharmaceuticals. "With this drug, patients undergoing cytotoxic chemotherapy are spared the administration of the pharmacologically inactive dextro-isomer. Preclinical studies have shown that the dextro-isomer may compete with the active levo-isomer for transport into cells."
The Company plans to file for a supplemental New Drug Application with the FDA for use in colorectal cancer in 5-fluorouracil containing regimens and an NDA amendment for an oral tablet formulation by mid-year 2008.
Levoleucovorin for Injection is currently listed as a replacement for calcium leucovorin in the NCCN Clinical Practice Guidelines in Oncology. The NCCN Drugs and Biologics Compendium is an important reference that has been recognized by United HealthCare as a formal guidance for approval of coverage policy. Visit www.nccn.org for more information.
Conference Call
Spectrum Pharmaceuticals will host a conference call to discuss the approval of Levoleucovorin for Injection and Tentative launch plans on:
Monday, March 10, 2008 @ 4:30pm Eastern/1:30pm Pacific
--------------------------------------------------
Domestic: 866-510-0710 passcode 52089784
International: 617-597-5378 passcode 52089784
Webcast and replays: www.spectrumpharm.com.
Audio replays will be available through March 17, 2008.
Domestic: 888-286-8010, passcode 61786785
International: 617-801-6888, passcode 61786785
Hat sich in den letzten Tagen schon verdoppelt, möglicherweise also nicht der beste Einstiegszeitpunkt.
Infolge der neuen Kooperation mit Allergan bekommt Spectrum eine Upfront Zahlung:
Allergan, Inc. and Spectrum Pharmaceuticals, Inc. Announce Collaboration Agreement for Apaziquone (EOquin(R))
Wednesday October 29, 9:00 am ET
-- Apaziquone is Currently Being Investigated for the Treatment of Non-Muscle Invasive Bladder Cancer
-- Spectrum to Receive $41.5 Million at Closing and up to $304 Million in Milestone Payments
-- Spectrum to Share Profits and Expenses Equally in the United States and Receive Royalties on Allergan's Sales Outside of the United States
Allergan, Inc. and Spectrum Pharmaceuticals, Inc. Announce Collaboration Agreement for Apaziquone (EOquin(R))
--------------
ISO-Vorin (siehe Eingangsposting) läuft jetzt auf dem Handelsnamen Fusilev, Montag soll das Filing von Fusilev für den zweiten, viel grösseren Anwendungsbereich Colorectal Cancer eingereicht werden (Umsatzerwartung dann ~$200Mio).
http://www.spectrumpharm.com/presentations/corporate/index.html
Gruss macos
Wednesday November 26, 10:02 am ET
- ZEVALIN is Currently FDA Approved for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
- sBLA for First Line Consolidation Therapy Is Currently Under Review By The FDA
- Complements Existing and Potential Oncology Product Portfolios of Both Companies
IRVINE, Calif., and SEATTLE, Nov. 26 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) and Cell Therapeutics, Inc. (Nasdaq: CTIC - News; MTA: CTIC) announced today they have entered into an agreement to form a 50/50 owned joint venture, RIT Oncology LLC, to commercialize and develop ZEVALIN® ([90Y]-ibritumomab tiuxetan) in the United States. ZEVALIN, a radioimmunotherapeutic (RIT), is currently marketed in the United States by Cell Therapeutics, Inc. (CTI) 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 submitted a supplemental Biologics License Application (sBLA) in September 2008 to expand the label for use in first-line consolidation therapy in previously untreated patients with follicular NHL.
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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. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with, and approximately 19,160 are expected to die from, this disease in 2008. According to the National Cancer Institute's SEER database, there were approximately 400,000 people in the U.S. with NHL in 2004.
"ZEVALIN represents a powerful addition to our marketed oncology drug portfolio," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "ZEVALIN is safe and effective in treating indolent NHL. Although approved by the FDA in 2002, its potential has not been fully realized. We are proud to partner with Cell Therapeutics, which over the past year has made great headway toward removing many of the obstacles that have kept this important drug from patients that could benefit from it. There are approximately one thousand patients currently receiving ZEVALIN treatments for refractory indolent NHL, generating approximately $15 million in annual sales. If approved for first line consolidation therapy in indolent NHL, we estimate that an additional 18,000 patients per year would be eligible to receive ZEVALIN in this setting. We assembled an experienced sales force, comprised of individuals with established track records of success, to launch our recently approved drug FUSILEV. ZEVALIN represents a complementary product that our sales force can provide to their accounts."
"This partnership is especially important as we hope to move toward use of ZEVALIN in first-line consolidation treatment of indolent NHL patients, which would significantly expand the available patient population," said James A. Bianco, M.D., CEO of Cell Therapeutics. "This partnership will enable CTI to deploy a larger combined sales and marketing team to accelerate top-line product revenues in the near-term and reduce our costs to develop ZEVALIN for new growth opportunities, resulting in an increase in CTI's bottom-line overall. Spectrum has a wealth of experience in the field of oncology, including the sales and marketing leadership that oversaw the successful launch of Abraxane® and Xeloda®. We believe the Spectrum partnership allows us to better serve patients and capitalize on the growing recognition of ZEVALIN's effectiveness in patients with indolent NHL, while at the same time provide a significant return on investment for our shareholders."
Under terms of the agreement, upon the closing of the transaction the companies will become the sole members of a limited liability company (LLC) whose sole purpose would be to commercialize ZEVALIN in the United States. A Board of Managers comprised of an equal number of members from both companies would be established to govern the LLC. 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 will receive an initial payment of $7.5 million at closing and $7.5 million in early January, in addition up to $15 million product sales milestone payments upon achievement of certain revenue targets. The closing of the joint venture transaction is subject to the satisfaction of certain customary closing conditions, including the consent of Biogen Idec, Inc. to convey the ZEVALIN-related assets to the LLC. CTI and Spectrum currently expect the transaction to close in December 2008.
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.
About ZEVALIN®
ZEVALIN® (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-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®) 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.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.
Forward-looking statements -- This press release may contain forward- looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, as well as its contemplated transaction with Cell Therapeutics, Inc, the safety and effectiveness of ZEVALIN, ZEVALIN's potential, that if approved for first line therapy in NHL, an additional 18,000 patients per year would be eligible to receive ZEVALIN in that setting, that ZEVALIN represents a complementary product that our sales force can provide to their accounts, that the transaction will close in December 2008 and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates, may not prove safe or effective, the possibility that its existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Information regarding Cell Therapeutics has been provided by Cell Therapeutics and not independently verified by Spectrum. Any comments by Cell Therapeutics are solely those of Cell Therapeutics and do not necessarily represent the views of Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN® is a registered trademark of RIT Oncology, Inc.
© 2008 Spectrum Pharmaceuticals, Inc.
Cell Therapeutics Forward Looking Statement
This press release includes forward-looking statements that involve a number of risks and uncertainties, including whether the closing conditions, including the consent of Biogen Idec, Inc., will be satisfied in order to consummate the joint venture transaction, 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 potential that the FDA will not grant priority review to the sBLA, the ability of CTI to continue to raise capital to fund its operations, 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.
Spectrum Contacts
Russell Skibsted - Chief Business Officer
949-788-6700x234
Paul Arndt - Manager, Investor Relations
949-788-6700x234
Cell Therapeutics Contacts
Media Contact:
Dan Eramian, 206-272-4343
media@ctiseattle.com
www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell, 206-272-4345
Lindsey Jesch Logan, 206-272-4347
invest@ctiseattle.com
http://www.CellTherapeutics.com/investors
--------------------------------------------------
Source: Spectrum Pharmaceuticals, Inc.; Cell Therapeutics, Inc.
08:49 12.12.08
Kulmbach (aktiencheck.de AG) - Die Experten vom "TREND INVEST REPORT" sind der Meinung, dass Anleger ihre Kauforder bei der Aktie von Spectrum Pharmaceuticals (Profil) streng limitieren sollen.
Die Finanzkrise ziehe weiterhin ihre Kreise. Auch im Biotech-Sektor dürften für kleinere Unternehmen schwierige Zeiten anbrechen. So würden laut einer aktuellen Studie aus den USA rund 100 kleine, börsennotierte Biotech-Unternehmen nur mehr über Barmittel für sechs Monate verfügen. Die Finanzierung künftiger Studien dürfte somit vielen Unternehmen schwer fallen.
Ganz anders stelle sich die Situation jedoch bei Spectrum Pharmaceuticals dar. Mit einer Marktkapitalisierung von gut 53 Millionen US-Dollar sei Spectrum ein klassischer Biotech-Smallcap. Nachdem das Unternehmen im laufenden Jahr seine Generikasparte verkauft und eine Kooperation mit Allergan zur weiteren Entwicklung und Vermarktung des Krebsmedikamentes Eoquin geschlossen habe, stehe es finanziell so gut da wie lange nicht mehr. Der Cashbestand von 90 Millionen US-Dollar habe zum Stichtag 6. November die Marktkapitalisierung sogar deutlich überstiegen.
Daneben könne sich aber auch die Pipeline von Spectrum sehen lassen. Mit Fusilev befinde sich das erste Krebsmedikament zur Behandlung des Osteosarkoms, eines bösartigen Knochentumors, seit Mitte August auf dem Markt. Die Experten würden allein durch dieses Medikament mit Erlösen im nächsten Jahr zwischen acht und zehn Millionen US-Dollar rechnen. Daneben würden durch die Kooperation mit Allergan in den nächsten Jahren Meilensteinzahlungen von über 300 Millionen US-Dollar winken.
Spectrums Neuausrichtung mit Fokussierung auf den Bereich Onkologie überzeuge.
Anleger sollten ihre Kauforder bei der Aktie von Spectrum Pharmaceuticals jedoch streng limitieren, so die Experten vom "TREND INVEST REPORT". (Ausgabe 50 vom 10.12.2008) (12.12.2008/ac/a/a)
http://www.spectrumpharm.com/presentations/corporate/index.html
13:10 22.01.09
Study Results Published in the January 15, 2009 Annals of Oncology
IRVINE, Calif.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) announced today results of a study published by Esmaeli, et al. online on January 15, 2009 in the Annals of Oncology demonstrating that rituximab followed by single agent ZEVALIN® (ibritumomab tiuxetan) in a front-line setting for patients with MALT lymphoma and low-grade follicular lymphoma that primarily involved the conjunctiva or orbit, produced a complete response rate of 83 percent.
Ocular adnexal lymphoma (OAL), defined as lymphoma affecting the orbit, eyelid and conjunctiva, is the most frequent primary malignant tumor of the orbit in adults, accounting for approximately 55 percent of all orbital tumors. MALT lymphoma is the most common histologic subtype of OAL, followed by low-grade follicular lymphoma. External-beam radiotherapy (EBRT) has been the most frequently used modality and is considered the gold standard for treating OAL that present with local disease. However, EBRT does not address systemic sites of involvement in OAL in patients with multifocal disease and therefore, systemic targeted radioimmunotherapy with ZEVALIN might offer an alternative to treating OAL.
In the study, 9 patients with MALT lymphoma of conjunctiva or orbit and 3 patients with low grade follicular lymphoma of the orbit received rituximab and Indium-111 ZEVALIN and then approximately 1 week later received a second infusion of rituximab followed by single dose of Yttrium-90 ZEVALIN.
Results demonstrated an initial response rate for patients of 100 percent with 83 percent achieving a complete response. There were no cases of extraorbital relapse, with a median follow-up time of 20 months. All 12 patients experienced Grade 1 or 2 transient pancytopenia during the first 3 months. Two patients had platelet transfusions, and one patient had blood transfusions due to myelosuppression. There were no episodes of Grade 3 or 4 toxicity.
The authors concluded that ZEVALIN may represent a reasonable alternative for front-line treatment of early-stage extranodal OAL, producing response rates similar to those with EBRT with one-tenth the absorbed radiation dose.
ZEVALIN is currently marketed in the United States by RIT (Radioimmunotherapeutics) Oncology, LLC, a joint venture between Spectrum Pharmaceuticals, Inc. and Cell Therapeutics, Inc. A sNDA for ZEVALIN as front-line consolidation therapy in patients with advanced follicular NHL has been submitted to the FDA for review. 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.
About ZEVALIN®
ZEVALIN® (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®) 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.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About Non-Hodgkins Lymphoma
Non-Hodgkins 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 Institutes 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 First-Line Consolidation Therapy
Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.
About RIT (Radioimmunotherapeutics) Oncology, LLC
Spectrum Pharmaceuticals and Cell Therapeutics 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 are to equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.
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 www.celltherapeutics.com.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.
Forward-looking statements -- This press release may contain forward- looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, the safety and effectiveness of ZEVALIN, that ZEVALIN may represent a reasonable alternative for front-line treatment of early-stage extranodal OAL, producing response rates similar to those with EBRT with one-tenth the absorbed radiation dose, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates, may not prove safe or effective, the possibility that its existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN® is a registered trademark of RIT Oncology, LLC, and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.
© 2009 Spectrum Pharmaceuticals, Inc.
(c)2007 Business Wire. All of the news releases contained herein are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire's members, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.
13:05 23.02.09
Cell Therapeutics Exercises Its Option To Sell Its Interest In ZEVALIN® JV; Spectrum Has Up to 30 Days to Close FDA Sets July 2, 2009 as New PDUFA Action Date For ZEVALIN in First Line Consolidation Therapy After Additional Data Was Received on February 5, 2009 FUSILEV Sales to Date Are Expected To Substantially Fund the Acquisition Cost of Up To $18 Million Plans for ZEVALIN on Track; Strong Synergies with FUSILEV Anticipated Spectrum Will Host a Conference Call on Thursday, February 26th at 1:30pmET/10:30amPT
IRVINE, Calif.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) today announced that Cell Therapeutics exercised its option to sell its 50% ownership interest in RIT Oncology LLC to Spectrum for up to $18 million, in three installments (closing, 45 days from closing, 90 days from closing). Per the agreement, Spectrum will have up to 30 days in which to close, assuming CTI fulfills all closing conditions. After the close of the transaction, Spectrum Pharmaceuticals will have 100% ownership in RIT Oncology LLC, and will be responsible for all manufacturing, sales, marketing, and commercialization activities for ZEVALIN® (ibritumomab tiuxetan).
ZEVALIN is currently approved 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.
"We are very excited at the prospect of a 100% ownership in RIT Oncology," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Following the anticipated approval of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma, we expect the combination of compelling new clinical data, together with anticipated regulatory and reimbursement changes and a robust sales and marketing effort, to substantially improve patient access to ZEVALIN. Securing full rights to ZEVALIN following the close of this transaction should also increase the return on our investment, and facilitate synergies with our FUSILEV franchise. Additionally, we expect FUSILEV sales to date to substantially fund the ZEVALIN acquisition."
On November 28, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.
An amendment to the sBLA was received by FDA on February 5, 2009. This submission was considered to be a major amendment, and because the receipt date was within three months of the user fee goal date, FDA extended the goal date by three months to July 2, 2009, to allow for a full review of the amendment.
Conference Call
Thursday, February 26, 2009 @ 1:30p.m. Eastern/10:30 a.m. Pacific
Domestic: 866-700-7173 passcode 68723288
International: 617-213-8838 passcode 68723288
Webcast and replays: www.spectrumpharm.com.
Audio replays will be available through March 5, 2009.
Domestic: 888-286-8010, passcode 17320931
International: 617-801-6888, passcode 17320931
About ZEVALIN®
ZEVALIN® (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®) 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.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About Non-Hodgkins Lymphoma
Non-Hodgkins 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 Institutes 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 First-Line Consolidation Therapy
Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.
About RIT (Radioimmunotherapeutics) Oncology, LLC
Spectrum Pharmaceuticals and Cell Therapeutics 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 are to equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.
Forward-looking statements -- This press release may contain forward- looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, the safety and effectiveness of ZEVALIN, that we anticipate approval of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma, that CTI will fulfill all of its obligations to close the transaction, that we expect the combination of compelling new clinical data, together with anticipated regulatory and reimbursement changes and a robust sales and marketing effort, to substantially improve patient access to ZEVALIN, that securing full rights to ZEVALIN following the close of this transaction should also increase the return on our investment, and facilitate synergies with our FUSILEV franchise, that we expect FUSILEV sales to date to substantially fund the ZEVALIN acquisition and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates, may not prove safe or effective, the possibility that its existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN® is a registered trademark of RIT Oncology LLC, and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.
© 2009 Spectrum Pharmaceuticals, Inc.
(c)2007 Business Wire. All of the news releases contained herein are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire's members, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited w
09:22 06.03.09
Kulmbach (aktiencheck.de AG) - Die Experten vom "TREND INVEST REPORT" empfehlen die Aktie von Spectrum Pharmaceuticals (Profil) zu kaufen.
Bereits im Dezember hätten die Experten auf die Biotech-Schmiede Spectrum hingewiesen und die Aktie in das Depot genommen. Wie sich immer mehr herauskristallisiere, schlummere in dem Titel enormes Potenzial. Bereits seit Mitte letzten Jahres vermarkte Spectrum sein erstes Medikament Fusilev, das zur Behandlung des Osteosarkoms, eines bösartigen Knochentumors eingesetzt werde - mit großem Erfolg. Wie Firmenchef Rajesh C. Shrotriya in einer Präsentation jüngst mitgeteilt habe, hätten die Fusilev-Umsätze allein im letzten Quartal 2008 bei 7,7 Millionen US-Dollar gelegen. Für ein Unternehmen mit einer Marktkapitalisieurng von gerade einmal 45 Millionen US-Dollar sei das mehr als beachtlich. Damit aber nicht genug.
Spectrum habe sich vor einigen Tagen vom angeschlagenen Biotech-Mitstreiter Cell Therapeutics die US-Vermarktungsrechte für Zevalin gesichert. Zevalin sei in den USA als Drittlinientherapie bei Patienten zugelassen, die am so genannten Non-Hodgkin-Lymphom, einer bestimmten Art von Blutkrebs, leiden würden und habe es im vergangenen Jahr auf Umsätze von über zehn Millionen US-Dollar gebracht. Am 2. Juli falle die FDA eine Entscheidung, ob Zevalin auch als Konsolidierungstherapie bei fortgeschrittenem Non-Hodgkin-Lymphom eingesetzt werden dürfe. Da Zevalin in Europa in dieser Indikation bereits seit Jahren angewandt werde, dürfte die Zulassung nur mehr Formsache sein. Für Spectrum wäre dies ein weiterer großer Erfolg.
2009 werde das Jahr des Durchbruchs bei Spectrum. Der "TREND INVEST REPORT" rechne mit Erlösen über 20 Millionen US-Dollar, das KUV liege nur bei 2.
Die Experten vom "TREND INVEST REPORT" raten die Aktie von Spectrum Pharmaceuticals zu kaufen. (Ausgabe 10 vom 04.03.2009) (06.03.2009/ac/a/a)
Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.
12:10 26.03.09
Deutschland handelt ab jetzt automatisiert! www.xtb.de Anzeige Target Action (PDUFA) Date Set By the FDA is October 8, 2009
IRVINE, Calif.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) announced today that it received notification that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009.
The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. In December 2008, FUSILEV was listed in the National Comprehensive Cancer Network® (NCCN) Drugs and Biologic Compendium to be used in combination with high-dose methotrexate for the treatment of bone cancer (osteosarcoma and dedifferentiated chrondrosarcoma), and the NCCN Clinical Practice Guidelines in Oncology in Colon Cancer and Rectal Cancer were updated to reflect that FUSILEV is available in the United States.
About FUSILEV (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.fusilev.com.
About NCCN
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the worlds leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.
World-renowned experts from NCCN Member Institutions diagnose and treat patients with a broad spectrum of cancers and are recognized for dealing with complex, aggressive, or rare cancers. More than 160,000 new patients receive cancer care at NCCN Member Institutions over the course of any year. NCCN Member Institutions pioneered the concept of the multidisciplinary team approach to patient care and lead the fight against cancer as they integrate programs in patient care, research, and education. Our programs offer access to expert physicians, superior treatment, and quality and safety initiatives that continuously improve the effectiveness and efficiency of cancer care. Thirty-seven Nobel Prize winners have served on the faculties of NCCN Member Institutions.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.
Forward-looking statement This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of FUSILEV and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Information regarding NCCN has been obtained from NCCNs website and not independently verified by Spectrum.
SPECTRUM PHARMACEUTICALS, INC. ® is a registered trademark owned by Spectrum Pharmaceuticals, Inc. FUSILEV, TURNING INSIGHTS INTO HOPE, and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
(c)2007 Business Wire. All of the news releases contained herein are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire's members, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.Aktien|DAXTecDAXDow JonesNasdaq 100weitere (Realtime-)Listen
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08:47 01.04.09
Rating-Update:
New York (aktiencheck.de AG) - Shiv Kapoor, Analyst von Morgan Joseph & Co, stuft die Aktie von Spectrum Pharmaceuticals (Profil) weiterhin mit dem Rating "buy" ein. Das Kursziel werde bei 5 USD gesehen. (01.04.2009/ac/a/u)
Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.
sonst hätte Raj nicht gekauft.
phx.corporate-ir.net/phoenix.zhtml
