Millennium Announces VELCADE Presentations and First Data in Solid Tumors for Pipeline Molecules at American Society of Cl

-- Data focus on VELCADE as foundation of multiple myeloma therapy --

-- Investigational oncology molecules in solid tumors highlighted --

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Millennium: The Takeda Oncology Company today announced that 71 oral and poster presentations featuring VELCADE® (bortezomib) for Injection or the Company’s oncology pipeline molecules will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, Illinois, June 4-8, 2010. These data include five oral presentations on the use of VELCADE based therapy across a spectrum of multiple myeloma treatment settings.

Additionally, VELCADE is being highlighted in five presentations at the newly established, exclusive Trials in Progress session. This session will highlight abstracts on trial design and accepts a limited number of abstracts for all disease states.

First clinical data will be presented for two of the Company’s novel pipeline compounds being investigated in solid tumors. Presentations include data on MLN9708, the first oral proteasome inhibitor; and TAK-701, an anti-hepatocyte growth factor (HGF) antibody. Phase I data will also be presented for MLN8237, an oral, selective Aurora A kinase inhibitor. The first Phase II data will be presented on TAK-700, a selective 17,20 lyase inhibitor.

“Data being presented at this year’s ASCO further demonstrate the effectiveness of VELCADE as a backbone of therapy in a range of multiple myeloma patient populations and treatment settings,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “Our expertise in oncology development, as demonstrated by the success of VELCADE, has enabled us to quickly advance clinical development of our pipeline molecules in a variety of solid tumors. We’re pleased to see the first clinical data presentations for two of our pipeline molecules, including our oral proteasome inhibitor.”

VELCADE Data

A total of 48 abstracts featuring VELCADE were accepted for publication or presentation. These data include VELCADE based combinations in both transplant and non-transplant eligible previously untreated MM patients, as well as VELCADE used as induction and/or maintenance therapy. Emerging data presented at ASCO include VELCADE for the treatment of patients with AL amyloidosis. Presentation highlights are scheduled to include:

  • Bortezomib, melphalan, prednisone and thalidomide (VMPT) followed by maintenance with bortezomib and dexamethasone (VD) for initial treatment of elderly multiple myeloma patients
    • Presenter: Mario Boccadoro, M.D., University of Torino and Italian Multiple Myeloma Study Group, Torino, Italy
    • Abstract #8013: Oral presentation session: Sunday, June 6, 9:30 am CT
  • Lenalidomide, bortezomib, dexamethasone in patients with newly diagnosed multiple myeloma (MM): final results of a multicenter Phase I/II study
    • Presenter: Kenneth Anderson, M.D., Dana-Farber Cancer Institute, Boston, MA
    • Abstract #8016: Oral presentation session: Sunday, June 6, 10:30 a.m. CT
  • Reduced-dose bortezomib plus thalidomide (vTD) is superior to bortezomib plus dexamethasone (VD) as induction treatment prior to ASCT in de novo multiple myeloma (MM): results of IFM2007-02 study
    • Presenter: Philippe Moreau, M.D., Hôpital de Nantes, Nantes, France
    • Abstract #8014: Oral presentation session: Sunday, June 6, 9:45 am CT
  • Weekly and twice-weekly bortezomib in AL amyloidosis: results of a phase 2 study
    • Presenter: Donna Reece, M.D., FRCPC, Princess Margaret Hospital, Toronto, Canada
    • Abstract #8023: Poster discussion session: Friday, June 4, 2:00 pm CT

Pipeline Solid Tumor Data

TAK-700, a compound in development for the treatment of prostate cancer, will have a first presentation of Phase II data. This study is examining the use of TAK-700 in patients with metastatic castration-resistant prostate cancer. Phase I data from that study were presented in March 2010 at ASCO’s Genitourinary Cancers Symposium (ASCO GU) held in San Francisco, California.

MLN8237 is an oral compound designed to selectively inhibit Aurora A kinase and was discovered by Millennium scientists. Data from this ongoing Phase I trial were selected for oral presentation during the Developmental Therapeutics – Experimental Therapeutics session. First clinical data of MLN8237 were presented at the 2009 Annual Meeting of ASCO.

Additional presentations at ASCO will include the presentation of first clinical data for several investigational molecules from the Company’s robust oncology pipeline. MLN9708 is the first oral proteasome inhibitor to enter clinical trials and is based on the Company’s groundbreaking research in protein homeostasis. Phase I data are being presented at this year’s ASCO. TAK-701 is a humanized monoclonal antibody against HGF. Currently, TAK-701 is in Phase I clinical trials for advanced malignancies. Key presentations at ASCO are scheduled to include:

  • Safety, pharmacokinetics and efficacy of TAK-700 in metastatic castration-resistant prostate cancer: a phase 1/2 open-label study
    • Presenter: Robert Dreicer, M.D., FACP, Cleveland Clinic, Cleveland, Ohio
    • Abstract #3084: Poster presentation session: Monday, June 7, 8 :00 am CT
  • Phase I study of the investigational drug MLN8237, an Aurora A kinase (AAK) inhibitor, in patients (pts) with solid tumors
    • Presenter: E. Claire Dees, M.D., M.Sc., University of North Carolina, Chapel Hill, North Carolina
    • Abstract #3010: Oral presentation session: Saturday, June 4, 2:15 pm CT
  • First-in-human phase 1 dose-escalation study of investigational drug MLN9708, a second-generation proteasome inhibitor, in advanced non-hematologic malignancies
    • Presenter: Eve Rodler, M.D., Seattle Cancer Care Alliance, Seattle, Washington
    • Abstract #3071: Poster presentation session: Monday, June 7, 8 :00 am CT
  • Safety, tolerability and pharmacokinetics of TAK-701, a humanized anti-hepatocyte growth factor (HGF) monoclonal antibody, in patients with advance nonhematologic malignancies: first-in-human phase I dose-escalation study
    • Presenter: Suzanne Fields Jones, PharmD, The Sarah Cannon Cancer Center, Nashville, Tennessee
    • Abstract #3081: Poster presentation session: Monday, June 7, 8 :00 am CT

About VELCADE

VELCADE is co-developed by Millennium and Ortho Biotech Oncology Research & Development, a 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. entered into a co-promote agreement in May 2010 for VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 160,000 patients worldwide.

Important Safety Information

CONTRAINDICATION

VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

WARNINGS AND PRECAUTIONS

VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE.

Pregnancy and Nursing: Women should avoid breastfeeding or becoming pregnant while being treated with VELCADE.

Peripheral neuropathy, including severe cases, may occur – manage with dose modification or discontinuation. Patients with pre-existing symptoms may experience worsening peripheral neuropathy (including ≥ Grade 3). Patients should be monitored for symptoms of peripheral neuropathy.

Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope and those who are dehydrated.

Cardiac Disorders including acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have been reported. Isolated cases of QT-interval prolongation have been reported. Patients with risk factors for, or existing heart disease should be closely monitored.

Pulmonary Disorders, some fatal, including pneumonitis interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS), have been reported. Pulmonary hypertension in the absence of left heart failure or significant pulmonary disease has also been reported.

Gastrointestinal Adverse Events including nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia/Neutropenia can occur – manage with dose and/or schedule modifications. Platelets should be monitored prior to each dose of VELCADE. There have been reports of gastrointestinal and intracerebral hemorrhage. Transfusions may be considered.

Patients with Hepatic Impairment: VELCADE exposure is increased in patients with moderate or severe hepatic impairment. These patients should be started at a lower dose of VELCADE, which can be adjusted after cycle 1 depending on tolerability.

Patients with Diabetes: Hypoglycermia and hyperglycemia have been reported with VELCADE use. Patients may require close monitoring and adjustment of the antidiabetic medications.

Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome (RPLS) and acute hepatic failure have been reported.

Adverse Reactions

Previously Untreated MM: In the phase 3 VELCADE with melphalan and prednisone study, the most commonly reported adverse events were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%).

Relapsed MM and MCL: In the integrated analysis of 1163 patients in phase 2 and 3 studies, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%).

In the integrated analysis, a total of 50% of patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

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 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.

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



CONTACT:

Manisha Pai, 617-551-7877
[email protected]
or
Millennium
Lauren Musto, 617-551-7848
[email protected]

KEYWORDS:   United States  North America  Illinois  Massachusetts

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical  Research  Science

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