CORRECTING and REPLACING Takeda Announces 118 Abstracts on VELCADE® (bortezomib), ADCETRIS® (brentuximab vedotin) and Leading Pipeline Compounds to be Presented at 55th American Society of Hematology Annual Meeting<4502.T>

Tue Nov 12, 2013 5:49pm EST

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CORRECTING and REPLACING Takeda Announces 118 Abstracts on VELCADE® (bortezomib), ADCETRIS® (brentuximab vedotin) and Leading Pipeline Compounds to be Presented at 55th American Society of Hematology Annual Meeting

− Overall Survival Data Featured for VELCADE and ADCETRIS –

Oral MLN9708 Update Featured

Please replace the release dated November 11, 2013 with the following correction version due to multiple revisions.

The corrected release reads:

TAKEDA ANNOUNCES 118 ABSTRACTS ON VELCADE® (BORTEZOMIB), ADCETRIS® (BRENTUXIMAB VEDOTIN) AND LEADING PIPELINE COMPOUNDS TO BE PRESENTED AT 55TH AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING

− Overall Survival Data Featured for VELCADE and ADCETRIS –

Oral MLN9708 Update Featured

Takeda Pharmaceutical Company Limited (TSE:4502) today announced 118 abstracts, involving five molecules in the company’s portfolio, have been accepted for presentation at this year’s American Society of Hematology (ASH) annual meeting to be held December 7-10, 2013 in New Orleans, Louisiana. These abstracts include presentations for VELCADE® (bortezomib) for Injection and ADCETRIS® (brentuximab vedotin) and three of the company’s pipeline agents, including MLN9708, the first oral proteasome inhibitor to enter Phase 3 development.

Presentations on VELCADE include an analysis of overall survival (OS) from the VISTA trial in previously untreated multiple myeloma (MM). Other presentations will feature new Phase 2 data on MLN9708 and the long-term survival updates for ADCETRIS in relapsed/refractory Hodgkin Lymphoma and relapsed/refractory Anaplastic Large Cell Lymphoma.

“The updated overall survival results for VELCADE and ADCETRIS to be presented at this year’s ASH will be important data for patients with Multiple Myeloma and relapsed or refractory Hodgkin’s Lymphoma and Anaplastic Large Cell Lymphoma, respectively,” said Michael Vasconcelles, M.D., Head, Oncology Therapeutic Area Unit, Takeda. “Data for these products, as well as agents in the Takeda pipeline such as MLN9708, are providing meaningful insights in defining optimal therapy for a wide range of hematologic malignancies.”

Notable presentations at ASH will include:

VELCADE

  • Higher Cumulative Bortezomib Dose Results in Better Overall Survival (OS) in Patients with Previously Untreated Multiple Myeloma (MM) Receiving Bortezomib-Melphalan-Prednisone (VMP) in the Phase 3 VISTA Study
    • Presenter: María-Victoria Mateos, M.D., Hospital Universitario Salamanca, Salamanca, Spain
    • Abstract 1968, Poster Presentation, Saturday, December 7, 2013 5:30 PM-7:30 PM, Hall G (Ernest N. Morial Convention Center)
  • Quantifying the Risk of Heart Failure Associated With Proteasome Inhibition: a Retrospective Analysis of Heart Failure Reported in Phase 2 and Phase 3 Studies of Bortezomib (Btz) in Multiple Myeloma (MM)
    • Presenter: Jacob P. Laubach, M.D., Dana-Farber Cancer Institute, Boston, MA
    • Abstract 3187, Poster Presentation, Sunday, December 8, 2013, 6:30 PM-8:30 PM Hall G (Ernest N. Morial Convention Center),
  • Bortezomib Induction and Maintenance Treatment Improves Survival in Patients with Newly Diagnosed Multiple Myeloma: Extended Follow-up of the HOVON-65/GMMG-HD4 Trial
    • Presenter: Pieter Sonneveld, MD, Ph.D. Erasmus Medical Center Rotterdam, Rotterdam,
      the Netherlands
    • Abstract 404, Oral Presentation, Monday, December 9, 2013, 10:45 AM 393-394 (Ernest N. Morial Convention Center)

MLN9708

  • Twice-weekly Oral MLN9708 (ixazomib citrate), an Investigational Proteasome Inhibitor, in Combination with Lenalidomide (Len) and Dexamethasone (Dex) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (MM): Final Phase 1 Results and Phase 2 Data
    • Presenter: Paul G. Richardson, M.D., Dana-Farber Cancer Institute, Boston, MA
    • Abstract 535, Oral Presentation, Monday, December 9, 2013, 2:45 PM 393-394 (Ernest N. Morial Convention Center)

ADCETRIS

  • Three-year Follow-up Data and Characterization of Long-Term Remissions from an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma
    • Presenter: Ajay Gopal, M.D., University of Washington/ Fred Hutchinson Cancer Research Center, Seattle, WA
    • Abstract 4382, Poster Presentation, Monday, December 9, 2013 6:00 PM-8:00 PM, Hall G (Ernest N. Morial Convention Center)
  • Three-Year Survival Results from an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
    • Presenter: Barbara Pro, M.D., Kimmel Cancer Center, Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA
    • Abstract 1809, Poster Presentation, Saturday, December 7, 2013 5:30 PM-7:30 PM, Hall G (Ernest N. Morial Convention Center)

About VELCADE

VELCADE is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies. Millennium: The Takeda Oncology Company is responsible for commercialization of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 95 countries and has been used to treat more than 440,000 patients worldwide.

VELCADE: Important Safety Information

VELCADE® (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. VELCADE should not be administered intrathecally. Women should avoid becoming pregnant or breastfeeding while taking VELCADE. Patients with diabetes may require close monitoring and adjustment of their medication.

VELCADE can cause serious side effects, including:

  • Peripheral neuropathy. Nerve problems, which can be severe including muscle weakness, tingling, burning, pain, or loss of feeling in the hands and feet.
  • Low blood pressure. A drop in blood pressure resulting in dizziness, light headedness or fainting.
  • Heart problems. Heart rhythm problems and heart failure including worsening of existing conditions. Symptoms may include chest pressure or pain, palpitations, swelling of the ankles or feet, or shortness of breath.
  • Lung problems, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.
  • Liver problems. Liver failure including a yellow discoloration of the eyes and skin.
  • Posterior reversible encephalopathy syndrome (PRES). a rare, reversible condition involving the brain. Symptoms may include seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems
  • Gastrointestinal problems. Nausea, vomiting, diarrhea and constipation.
  • Thrombocytopenia and neutropenia. Lowering the levels of blood cells, which could result in a higher risk for infections or bleeding.
  • Tumor lysis syndrome (TLS). TLS is a syndrome that causes a chemical imbalance in the blood that could lead to heart and/or kidney problems.

Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, rash.

These are not all of the possible side effects with VELCADE. Please see the full Prescribing Information for VELCADE for a complete list available at VELCADE.com.

About ADCETRIS® (brentuximab vedotin)

ADCETRIS® (brentuximab vedotin) is the first and only targeted CD30 antibody-drug conjugate (ADC) being evaluated in a variety of CD30-expressing malignancies including Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The ADC utilizes Seattle Genetics’ proprietary technology, which employs a linker system designed to be stable in the bloodstream but to release monomethyl auristatin E (MMAE) upon internalization into CD30-expressing tumor cells.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30-positive HL: (1) following autologous stem cell transplant (ASCT), or (2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 36 countries outside the US and Canada. See important safety information below.

ADCETRIS for intravenous injection was granted accelerated approval by the FDA in August 2011 and approval with conditions by Health Canada in February 2013 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.

Millennium: The Takeda Oncology Company and Seattle Genetics 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 is solely responsible for development costs.

ADCETRIS U.S. Important Safety Information

BOXED WARNING Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.

Contraindication:

Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity.

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 G-CSF support, 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.
  • Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in ADCETRIS-treated patients. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider the diagnosis of PML in any patient presenting with new-onset signs and symptoms of central nervous system abnormalities. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture or brain biopsy. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
  • Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported with ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and administer appropriate medical therapy.
  • Embryo-fetal toxicity: 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, including Boxed WARNING, please see the full U.S. prescribing information for ADCETRIS at www.ADCETRIS.com.

Editors’ Note: This press release is also available under the Media section of the Company’s website at: www.millennium.com/InTheNews.aspx.

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 people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Takeda Pharmaceutical Company Limited
Corporate Communications Department
Tel +81-3-3278-2037
or
David Albaugh, +1-617-444-4456
david.albaugh@takeda.com

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