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December 7, 2012

Spectrum Pharmaceuticals Highlights 19 Abstracts at the 54th Annual Meeting of the American Society of Hematology (ASH), Atlanta, Georgia, December 8-11, 2012

  • Two oral and 10 poster presentations for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use
  • Three poster presentations for FOLOTYN® (pralatrexate injection) and four poster presentations for belinostat, a novel HDAC inhibitor

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced key presentations of clinical and scientific data at the 54th Annual Meeting of the American Society of Hematology (ASH), being held in Atlanta, Georgia, from December 8-11, 2012. The presentations include two oral presentations and 10 poster presentations for ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use, three poster presentations for FOLOTYN® (pralatrexate injection), and four poster presentations for belinostat, a novel histone deacetylase (HDAC) inhibitor.

"Nearly 20 presentations at ASH will feature clinical and scientific data for Spectrum's commercial products, ZEVALIN and FOLOTYN, as well as our late-stage drug candidate, belinostat," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "The ZEVALIN-related abstracts demonstrate its use in a multitude of diverse settings and potential indications in which this product is being tested, including transplantation, its use in elderly patients, in frontline treatment and in the treatment of relapsed/refractory disease, as well as in new drug combinations. The FOLOTYN-related abstracts include presentations on new, synergistic combinations with other approved agents and in difficult-to-treat indications, such as HTLV-1-induced leukemia/lymphoma, while belinostat-related presentations are studying new combinations and indications, such as in refractory AML/MDS, as well as research on this promising drug candidate's mechanism of action."

For more information about the ASH annual meeting and for a complete list of abstracts, please refer to the conference Web site at https://ash.confex.com/ash/2012/webprogram/start.html.

The following are key ZEVALIN-related abstracts being presented at the ASH meeting:

                 
Abstract #   Type   Title   First Author   Date/Time

Location

1978   Poster   Autologous Stem Cell Transplantation with Yttriumm-90-Ibritumomab Tiuxetan (Zevalin) Plus BEAM Conditioning in Patients with Refractory Non-Hodgkin Diffuse Large B-Cell Lymphoma: Results of a Prospective, Multicenter, Phase II Clinical Trial   Briones   Saturday, Dec. 8

5:30 PM-7:30 PM

 

Hall B1-B2

2742   Poster   RIT with 90Y Ibritumomab Tiuxetan in Patients with Non-Hodgkin Lymphoma Over 65 Years   Andrade   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

2687   Poster   A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients with Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma: an Eastern Cooperative Oncology Group Study (E3402)   Witzig   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

2726   Poster   90-Yttrium Ibritumomab Tiuxetan (Zevalin) and BEAM Chemotherapy (Z-BEAM) Vs BEAM for Autologous Stem Cell Transplantation in Lymphoma: Toxicity and Long Term Outcome From a Retrospective Multicentric Study of 123 Patients   Terriou   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

2729   Poster   Rituximab-PECC Induction Followed by 90y-Ibritumomab Tiuxetan Consolidation in Relapsed or Refractory DLBCL Patients Who Are Not Eligible for or After ASCT: Preliminary Results From a Phase II HOVON Study   Lugtenburg   Sunday, Dec 9,

6:00 PM-8:00 PM

 

Hall B1-B2

2753   Poster   Phase I Trial of Combination Therapy with 90y Ibritumomab Tiuxetan and Gemcitabine in Patients with Non-Hodgkin's Lymphoma, Final Report   Borghaei   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

3019   Poster   Collection of Hematopoietic Stem Cells After Previous Exposure to Ittrium-90 Ibritumumab Tiuxetan (Zevalin) Is Feasible and Does Not Impair Autologous Stem Cell Transplantation Outcome in Follicular Lymphoma   Derenzini   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

747   Oral   Nordic MCL3 Study: Zevalin Combined with High-Dose Chemotherapy Followed by Autologous Stem Cell Support As Late Intensification for Mantle Cell Lymphoma (MCL) Patients < 66 Years Not in CR After Induction Chemoimmunotherapy: No Benefit of Zevalin   Kolstad   Monday, Dec. 10, 5:00 PM

 

B312-B313a

3657   Poster   Short Course of Bendamustine and Rituximab Followed by 90Y-Ibritumomab Tiuxetan in Patients with Chemotherapy-Naïve Follicular Lymphoma: Early Results of "Fol-Brite"   Lansigan   Monday, Dec. 10,

6:00 PM-8:00 PM

 

Hall B1-B2

3648   Poster   FDG-PET/CT Early After 90Y-Ibritumomab Tiuxetan Therapy Predicts Outcome in Relapsed or Refractory Indolent B-Cell Lymphoma   Okada   Monday, Dec. 10,

6:00 PM-8:00 PM

 

Hall B1-B2

3681   Poster   Sustained Immune Competency and Long Term Molecular Remissions in FL Patients with FLIPI Risk Factors > 1, Treated Front Line with R-CHOP Followed by Consolidative 90 Υ-Radioimmunotherapy and Maintenance Rituximab   Berinstein   Monday, Dec. 10,

6:00 PM-8:00 PM

 

Hall B1-B2

812   Oral   Upfront Consolidation Combining Yttrium-90 Ibritumomab Tiuxetan and High Dose Therapy with Stem-Cell Transplantation in Poor Risk Patients with Diffuse Large B-Cell Lymphoma   Fruchart   Monday, Dec. 10

6:30 PM

 

B312-B313a

       

The following are key FOLOTYN-related abstracts being presented at the ASH meeting:

                 
Abstract #   Type   Title   First Author   Location
2735   Poster   Pralatrexate in Relapsed/Refractory HTLV-1 Associated Adult T-Cell Lymphoma/Leukemia: A New York City Multi-Institutional Experience   Lunning   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

2758   Poster   Novel Imaging Modalities in Innovative Xenograft Mouse Models of T-Cell Lymphoma Confirm Marked Synergy of Romidepsin and Pralatrexate   Jain   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

3660   Poster   Cutaneous Toxicity Associated with Pralatrexate in Cutaneous and Peripheral T-Cell Lymphoma   Parker   Monday, Dec. 10,

6:00 PM-8:00 PM

 

Hall B1-B2

       

The following are key belinostat-related abstracts being presented at the ASH conference:

                 
Abstract #   Type   Title   First Author   Location
1359   Poster   Mechanisms of Sensitivity and Resistance to Histone Deacetylase Inhibitors in Diffuse Large B-Cell Lymphoma   Tula-Sanchez   Saturday, Dec. 8,

5:30 PM-7:30 PM

 

Hall B1-B2

2725   Poster   Sirtuin Inhibition in Combination with Histone Deacetylase (HDAC) Inhibition Is Effective Therapy for Aggressive B-Cell Lymphomas in Both Pre-Clinical and Clinical Studies of Disease   Amengual   Sunday, Dec. 9,

6:00 PM-8:00 PM

 

Hall B1-B2

3588   Poster   Phase I Trial of Belinostat and Bortezomib in Patients with Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia in Blast Crisis - One Year Update   Holkova   Monday, Dec. 10,

6:00 PM-8:00 PM

 

Hall B1-B2

3891   Poster   Inhibition of Histone Deacetylase Activity Compromises Homologous Recombination Repair and Increases Sensitivity of Chemo-Resistant Chronic Lymphocytic Leukemia Cells to Olaparib   Agathanggelou   Monday, Dec. 10,

6:00 PM-8:00 PM

 

Hall B1-B2

       

About Non-Hodgkin's Lymphoma

According to the National Cancer Institute (www.cancer.gov), there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and approximately 18,940 deaths in the United States in 2012. Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.

About ZEVALIN® and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.

Important ZEVALIN® Safety Information

Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.

Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.

About FOLOTYN®

FOLOTYN, (pralatrexate injection), a folate analogue metabolic inhibitor, was discovered by Memorial Sloan-Kettering Cancer Center, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. FOLOTYN has been available to patients in the U.S. since October 2009. An updated analysis of data from PROPEL, the pivotal study of FOLOTYN in patients with relapsed or refractory PTCL, was published in the March 20, 2011 issue of the Journal of Clinical Oncology. FOLOTYN has patent protection through July 2022, based on a five-year patent term extension through the Hatch-Waxman Act. Please see full Prescribing Information for FOLOTYN at www.FOLOTYN.com.

Important FOLOTYN® Safety Information

Warnings and Precautions

FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.

Mucositis may occur. If greater-than or equal to Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.

Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor patients and treat if needed.

FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.

Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.

Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are greater-than or equal to Grade 3, omit or modify dose.

Adverse Reactions

The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Use in Specific Patient Population

Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Drug Interactions

Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance.

Please see FOLOTYN® Full Prescribing Information at www.FOLOTYN.com.

About Belinostat

Belinostat is a Class I and II HDAC inhibitor being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including short and continuous intravenous infusion; and oral administration.

Conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), Spectrum's pivotal, registrational Phase 2 BELIEF trial is evaluating intravenous belinostat as monotherapy for relapsed or refractory peripheral T-cell lymphoma (PTCL), an indication for which this drug candidate has been granted Orphan Drug and Fast Track designations by the FDA. The BELIEF trial is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory PTCL, who have failed at least one prior systemic therapy. The primary endpoint of the trial is centrally reviewed objective overall response rate (ORR). The trial included approximately 100 clinical centers globally, with completion of patient enrollment announced in September 2011.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.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 are based on management's current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, 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 applications to the FDA and other regulatory agencies may not receive approval 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 sustained revenue history, 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.

SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN® and ZEVALIN®, are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com

Source: Spectrum Pharmaceuticals, Inc.

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