Seattle Genetics and Millennium Announce Presentation of ADCETRIS™ Data at American Society of Hematology Annual Meeting

BOTHELL, Wash. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Seattle Genetics, Inc. SGEN and Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502), today announced that ADCETRIS™ (brentuximab vedotin) will be featured in multiple presentations at the 53^rd American Society of Hematology (ASH) Annual Meeting and Exposition being held December 10-13, 2011, in San Diego, Calif.

The presentations will include data from additional analyses and extended follow-up of patients from the pivotal trials in relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL), as well as data from a phase I combination clinical trial for front-line HL. A summary of the presentations is below, and full abstracts can be accessed on the ASH website at www.hematology.org.

ORAL PRESENTATIONS

Brentuximab Vedotin (SGN-35) in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma: A Phase 2 Study Update

• Monday, December 12, 2011; 11:30 a.m. Pacific Time (PT)
• Abstract #443
• Session: Lymphoma – Therapy with Biologic Agents, excluding Pre-Clinical Models: Mantle Cell and T Cell Lymphoma – Targeted Antibody and Small Molecule Approaches
• Location: Ballroom 20A
• First author: Dr. Ranjana Advani, Stanford University Medical Center, Stanford, California

Frontline Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma

• Tuesday, December 13, 2011; 7:30 a.m. PT
• Abstract #955
• Session: Lymphoma – Therapy with Biologic Agents, excluding Pre-Clinical Models: Novel Biologic Approaches to Aggressive and Hodgkin Lymphoma
• Location: Room 6B
• First author: Dr. Anas Younes, The University of Texas MD Anderson Cancer Center, Houston, Texas

POSTER PRESENTATIONS

Allogeneic Transplant Following Brentuximab Vedotin Treatment in Patients with Relapsed or Refractory CD30+ Lymphomas

• Sunday, December 11, 2011; 6:00 p.m. to 8:00 p.m. PT
• Abstract #3091
• Session: Clinical Allogeneic and Autologous Transplantation – Results: Poster II
• Location: Hall GH
• First author: Dr. Tim Illidge, Christie Hospital NHS, Manchester, United Kingdom

Prolonged Treatment with Brentuximab Vedotin (SGN-35) in Patients with Relapsed or Refractory Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

• Monday, December 12, 2011; 6:00 p.m. to 8:00 p.m. PT
• Abstract #3711
• Session: Lymphoma – Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III
• Location: Hall GH
• First author: Dr. Andres Forero-Torres, University of Alabama at Birmingham, Birmingham, AL

In addition, ADCETRIS data will be presented by investigators in two additional sessions as summarized below.

ORAL PRESENTATION

Brentuximab Vedotin (SGN-35) Enables Successful Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Relapsed/Refractory Hodgkin Lymphoma

• Monday, December 12, 2011; 3:30 p.m. PT
• Abstract #664
• Session: Clinical Allogeneic and Autologous Transplantation – Results: Novel Regimens and Prognostic Scoring
• Location: Douglas Pavillion C (Manchester Grand Hyatt San Diego)
• First author: Dr. Robert Chen, City of Hope National Medical Center, Duarte, CA

POSTER PRESENTATION

Preclinical Activity of Brentuximab Vedotin (SGN-35) in Primary Effusion Lymphoma (PEL)

• Monday, December 12, 2011; 6:00 p.m. to 8:00 p.m. PT
• Abstract #3728
• Session: Lymphoma – Pre-Clinical – Chemotherapy and Biologic Agents: Poster III
• Location: Hall GH
• First author: Dr. Shruti Bhatt, University of Miami, Miami, FL

ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration in August 2011 for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory Hodgkin lymphoma and systemic ALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted by the European Medicines Agency in June 2011.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. ADCETRIS™ was approved by the FDA on August 19, 2011, for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium and Takeda are available through their respective websites, http://www.millennium.com and http://www.takeda.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

U.S. Important Safety Information

Warnings and Precautions:

• Peripheral neuropathy: ADCETRIS treatment causes a peripheral neuropathy that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. ADCETRIS-induced peripheral neuropathy is cumulative. Treating physicians should monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness and institute dose modifications accordingly.
• Infusion reactions: Infusion-related reactions, including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted. If anaphylaxis occurs, the infusion should be immediately and permanently discontinued and appropriate medical management instituted.
• Neutropenia: Monitor complete blood counts prior to each dose of ADCETRIS and consider more frequent monitoring for patients with Grade 3 or 4 neutropenia. If Grade 3 or 4 neutropenia develops, manage by dose delays, reductions or discontinuation. Prolonged (≥1 week) severe neutropenia can occur with ADCETRIS.
• Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome and these patients should be monitored closely and appropriate measures taken.
• Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported with ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and administer appropriate medical therapy.
• Progressive multifocal leukoencephalopathy (PML): A fatal case of PML has been reported in a patient who received four chemotherapy regimens prior to receiving ADCETRIS.
• Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to the fetus.

Adverse Reactions:

ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (≥20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.

Drug Interactions:

Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions.

For additional important safety information, please see the full U.S. prescribing information for ADCETRIS at www.seattlegenetics.com or www.ADCETRIS.com.

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