VELCADE® (bortezomib), ADCETRIS® (brentuximab vedotin) and Millennium Pipeline Agents to be Featured at American Society of Hematology Annual Meeting

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced that more than 60 abstracts from studies involving five molecules in the Company's portfolio have been accepted for presentation at the annual meeting of the American Society of Hematology (ASH) being held December 8 – 11 in Atlanta, Georgia. The abstracts include oral and poster presentations across a range of hematological diseases.

Presentations include retreatment and maintenance data on VELCADE in multiple myeloma (MM). Data on once-weekly MLN9708, the first oral proteasome inhibitor in clinical trials, will be presented from two studies: the first as part of an all-oral triplet in previously untreated MM, and the second in relapsed or refractory light-chain amyloidosis. Additionally, data will be presented on ADCETRIS in combination with chemotherapy regimens in both previously untreated Hodgkin lymphoma and previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing mature T-cell and NK-cell lymphomas.

“The VELCADE and MLN9708 data being presented at ASH further demonstrate Millennium's leadership in protein homeostasis,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “Additionally, the promising ADCETRIS data serve as the basis for the continued development in earlier lines of CD30-expressing lymphomas.”

VELCADE

• Meta-analysis of the Efficacy and Safety of Bortezomib Retreatment in Patients with Multiple Myeloma
  • Presenter: Kevin B. Knopf, M.D., MPH, California Pacific Medical Center, San Francisco, CA
  • Abstract #1863: Poster presentation, Saturday, December 8, 5:30-7:30 p.m. ET, Hall B1-B2, Level 1, Building B, Georgia World Congress Center

MLN9708

• Phase 1 / 2 Study of Weekly MLN9708 an Investigational Oral Proteasome Inhibitor, in Combination with Lenalidomide and Dexamethasone in Patients with Previously Untreated Multiple Myeloma
  • Presenter: Shaji K. Kumar, M.D., Associate Professor of Hematology and Medicine, Rochester, MN
  • Abstract #332: Oral presentation, Monday, December 10, 7:15 a.m. ET, Thomas Murphy Ballroom 2-3, Level 5, Building B, Georgia World Congress Center

• MLN9708, a Novel, Investigational Oral Proteasome Inhibitor, in Patients with Relapsed or Refractory Light-Chain Amyloidosis (AL): Results of a Phase 1 Study
  • Presenter: Professor Giampaolo Merlini, MD, Amyloidosis Research and Treatment Center, University of Pavia, Italy
  • Abstract #731 : Oral presentation, Monday, December 10, 5:30 p.m. ET, Thomas Murphy Ballroom 2-3, Level 5, Building B, Georgia World Congress Center

ADCETRIS

• Brentuximab Vedotin Administered Concurrently with Multi-Agent Chemotherapy as Frontline Treatment of ALCL and Other CD30+ Mature T-Cell and NK-Cell Lymphomas
  • Presenter: Michelle Fanale, M.D., University of Texas MD Anderson Cancer Center, Houston, TX
  • Abstract #60: Oral presentation Sunday, December 9, 1:15 p.m. ET, Sidney Marcus Auditorium, Level 4, Building A, Georgia World Congress Center
• Frontline Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage HL
  • Presenter: Stephen M. Ansell, M.D., Ph.D., Medical Oncologist, Rochester, MN
  • Abstract #798: Oral presentation, Monday, December 10, 6:15 p.m. ET, B304-B305, Level 3, Building B, Georgia World Congress Center

About VELCADE

VELCADE is co-developed by Millennium and Janssen Pharmaceutical Companies. Millennium 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 90 countries and has been used to treat more than 340,000 patients worldwide.

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 also available at www.VELCADE.com.

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

About ADCETRIS^® (Brentuximab Vedotin)

ADCETRIS (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). 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.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2011 for two indications: (1) the treatment of patients with Hodgkin lymphoma 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 systemic anaplastic large cell lymphoma (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 was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) the treatment of patients with Hodgkin lymphoma 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 systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

See important safety information below.

ADCETRIS is a registered trademark of Millennium Pharmaceuticals, Inc.

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

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 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.
• 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, including Boxed WARNING, please see the full U.S. prescribing information for ADCETRIS at www.ADCETRIS.com.

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

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of 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 is available through its website, www.millennium.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.