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More than Thirty Abstracts on VELCADE® and Leading Millennium Pipeline Compounds to be Presented in Oral Sessions at 53rd American Society of Hematology Annual Meeting− Landmark VELCADE five-year follow-up data in previously untreated multiple myeloma to be featured in oral presentation −



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Press Releases

November 9, 2011

Takeda Pharmaceutical Company Limited
Millennium Pharmaceuticals, Inc.

More than Thirty Abstracts on VELCADE® and Leading Millennium Pipeline Compounds to be Presented in Oral Sessions at 53rd American Society of Hematology Annual Meeting
− Landmark VELCADE five-year follow-up data in previously untreated multiple myeloma to be featured in oral presentation −

CAMBRIDGE, Mass., November 8, 2011 – Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced 32 abstracts, involving six molecules in the Company’s portfolio, have been accepted for oral presentation at this year’s American Society of Hematology (ASH) annual meeting to be held December 10-13, 2011 in San Diego, California. These abstracts include oral presentations for VELCADE (bortezomib) for Injection and five of the Company’s pipeline agents, including MLN9708, the first oral proteasome inhibitor being studied in patients.

Presentations on VELCADE include five-year follow-up overall survival results from the pivotal randomized VISTA trial in previously untreated multiple myeloma (MM). Earlier this month, the FDA approved the addition of these data to the VELCADE label. Other presentations will feature data on VELCADE-based combinations in the consolidation and maintenance settings in MM as well as relapsed/refractory MM. In total, VELCADE will be highlighted in 81 abstracts, including 22 oral presentations.

Millennium pipeline compounds will be represented in 24 total presentations, including 10 oral sessions. Two of the Company’s leading pipeline candidates, MLN9708, an investigational oral proteasome inhibitor in development for the treatment of MM, and MLN8237, an investigational selective Aurora A kinase inhibitor for the treatment of non-Hodgkin lymphoma, will be featured in four oral presentations.

“Data being presented at this year’s meeting add to the growing body of evidence that supports the use of VELCADE in a wide variety of settings,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “We are pleased to note the prominence of MLN9708, along with our other pipeline agents, which are yielding new insights into key pathways relevant to hematologic malignancies.”

Notable presentations at ASH will include:

VELCADE

• Continued Overall Survival (OS) Benefit After 5 Years’ Follow-Up with Bortezomib-Melphalan-Prednisone (VMP) Versus Melphalan-Prednisone (MP) in Patients with Previously Untreated Multiple Myeloma, and No Increased Risk of Second Primary Malignancies: Final Results of the Phase 3 VISTA Trial

  • o Presenter: Jesús F. San Miguel, M.D., Hospital Universitario, Salamanca, CIC, IBMCC (USAL-CSIC), Spain
  • o Abstract #476, Oral Presentation, Monday, December 12, 2011, 10:45 am, Ballroom 20D, San Diego Convention Center

• Maintenance therapy with bortezomib plus thalidomide (VT) or bortezomib plus prednisone (VP) after induction with bortezomib, melphalan and prednisone (VMP) or bortezomib, thalidomide and prednisone (VTP) in elderly untreated myeloma patients included in the GEM2005MAS65 Spanish randomized trial.

  • o Presenter: María-Victoria Mateos, M.D., Hospital Universitario de Salamanca, Salamanca, Spain
  • o Abstract #477, Oral Presentation, Monday, December 12, 2011, 11:00 am, Ballroom 20D, San Diego Convention Center

MLN9708

• Investigational Agent MLN9708, An Oral Proteasome Inhibitor, in Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (MM): Results From the Expansion Cohorts of a Phase 1 Dose-Escalation Study

  • o Presenter: Paul G. Richardson, M.D. Clinical Director, Jerome Lipper Center for Multiple Myeloma, Dana-Farber Cancer Institute, Cambridge, MA
  • o Abstract #301, Oral Presentation, Monday, December 12, 2011, 7:00 am, Ballroom 20D, San Diego Convention Center

• Weekly Dosing of the Investigational Oral Proteasome Inhibitor MLN9708 in Patients with Relapsed and/or Refractory Multiple Myeloma: Results From a Phase 1 Dose-Escalation Study

  • o Presenter: Shaji K. Kumar, M.D., Associate Professor of Hematology and Medicine, Rochester, MN
  • o Abstract #816, Oral Presentation, Monday, December 12, 2011: 5:45 pm, Ballroom 20D, San Diego Convention Center

• Phase 1/2 Dose-Escalation Study of Oral MLN9708, A Novel, Investigational Proteasome Inhibitor, in Combination with Lenalidomide and Dexamethasone in Patients with Previously Untreated Multiple Myeloma

  • o Presenter: Jesus G. Berdeja, M.D., Sarah Cannon Research Institute, Nashville, TN
  • o Abstract #479, Oral Presentation, Monday, December 12, 2011, 11:30 am, Ballroom 20D, San Diego Convention Center

Oncology Pipeline

• Phase 2 Trial of Alisertib (MLN8237), An Investigational, Potent Inhibitor of Aurora A Kinase (AAK), in Patients (pts) with Aggressive B- and T-Cell Non-Hodgkin Lymphoma (NHL)

  • o Presenter: Jonathan Friedberg, M.D., James P. Wilmot Cancer Center, University of Rochester, Rochester, NY
  • o Abstract #95, Oral Presentation, Sunday, December 11, 2011, 5:30 pm, Ballroom 20A, San Diego Convention Center

• Azacitidine/Decitabine Synergism with the NEDD8-Activating Enzyme Inhibitor MLN4924 in Pre-Clinical AML Model

  • o Presenter: Michael A. Milhollen, Ph.D., Millennium Pharmaceuticals, Cambridge, MA
  • o Abstract #578, Oral Presentation, Monday, December 12, 2011, 3:00 pm, Room 30, San Diego Convention Center

About VELCADE

VELCADE is co-developed by Millennium and Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is 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 300,000 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. Women should be advised not to take VELCADE while pregnant or breast-feeding. Patients with diabetes may require close monitoring and adjustment of their medication.

VELCADE can cause serious side effects, including:

  • • Lowering the levels of blood cells, which could result in a higher risk for infections or bleeding.
  • • Nausea, vomiting, diarrhea and constipation.
  • • Nerve problems, which can be severe including muscle weakness, tingling, burning, pain, or loss of feeling in the hands and feet.
  • • A drop in blood pressure resulting in dizziness, light headedness or fainting.
  • • 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 disorders, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.
  • • Liver failure including a yellow discoloration of the eyes and skin.
  • • Tumor Lysis Syndrome and Reversible Posterior Leukoencephalopathy Syndrome have been reported.

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

Additional information and full prescribing information is available at www.VELCADE.com.
Please see the full prescribing information for VELCADE including warnings and precautions.

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).

# # #


Editors' 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.


Contacts:
Millennium
Manisha Pai
1- 617- 551- 7877
Manisha.paimpi.com

David Albaugh
1- 617- 444- 4456
david.albaughmpi.com

Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Tel: 81- 3- 3278- 2037

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