OUR HISTORY

Our history is a diverse tapestry interwoven by dutiful leadership, scientific innovation and passionate employees. This successful combination makes Millennium what it is today: a company that aspires to cure cancer.

Evolution of Our Company and Our Mission

Millennium Pharmaceuticals, Inc., was established in 1993 as a genomics company applying world-class recombinant technology to the discovery and development of innovative new therapies in a broad spectrum of diseases. Millennium has since grown into a fully integrated biopharmaceutical company with a pipeline of investigational drug candidates, as well as a successfully commercialized medicine derived from Nobel Prize-winning science that is now approved in more than 87 countries worldwide.

Evolution of Leadership

In May of 2005, the company's leadership changed as Founder Mark Levin turned the helm over to his carefully selected successor, Deborah Dunsire, M.D. Although considered remarkably different in management style, Dr. Dunsire embraced the company's culture and had the skills and experience Levin and the Board of Directors considered necessary to move the company forward to greater accountability and sustainable success.

For the next several years, significant refocusing and reconfiguration took place within Millennium, as well as considerable improvements in the scale and strength of Commercial Operations.

Evolution of Responsibility

In May, 2008, Millennium was acquired by Takeda Pharmaceutical Company Limited. Takeda is the largest pharmaceutical company in Japan, and a global enterprise with an important presence in key markets.

Millennium now operates as an independent subsidiary, serving as the global center of excellence in oncology under its new name: "Millennium: The Takeda Oncology Company." The merger of oncology resources has resulted in a more robust pipeline of investigational drug candidates.

This new function focuses Millennium efforts on expanding its scope of responsibility to the global oncology community. Along with an increased capacity in oncology comes increased accountability for success and a new mission that puts Millennium on a trajectory toward global oncology leadership.

This global footprint includes oncology research and marketing strategy and oversight. In addition to Cambridge, MA, oncology resources include facilities in San Diego, San Francisco, Tsukuba and Osaka with Millennium as the global hub for this critical and rapidly expanding therapeutic area.

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Cambridge

Detailed History

Millennium was founded in 1993 with a vision for innovation and excellence in science that still exists today. Since the inception, Millennium has differentiated itself with either first-in-class or best-in-class innovation – whether in discovery research, clinical development or commercial operations.

Achieving our Vision

In its early years, Millennium focused on building top-notch science and business teams to help achieve this vision. Attracted by scientific leadership, entrepreneurial spirit and rapid growth, Millennium earned the attention and respect of some of the best scientists and business people around the world.

Building Alliances

Beginning in 1994, Millennium created more than 20 strategic alliances with leading pharmaceutical and biotechnology companies. These alliances provided Millennium with close to $2 billion of committed funding that we used to develop and enhance our pipeline. With an innovative, integrated science and technology platform, expertise in drug-target discovery, and industry-leading partnerships, the company was well suited to be a competitive presence in drug research and development.

Through transformational mergers and acquisitions, Millennium advanced toward the goal of building a leading biopharmaceutical company. A merger with Leukosite in 1999 brought the company its first drug close to market, Campath® (alemtuzumab) Injection, and additional investigational drugs in clinical trials. In 2000, a merger with Cambridge Discovery Chemistry gave Millennium a strong presence in the United Kingdom and added to the organization more than 100 scientists with expertise in chemistry. In a strategic business decision, Campath was later sold to Genzyme.

In February 2002, a merger with COR Therapeutics – among the largest such mergers in the history of the biotech industry – helped to further solidify our standing as a leading biopharmaceutical company. In addition to creating a strong pipeline of novel therapeutics, the merger added cardiovascular research and drug development to the Company's other key therapeutic areas: oncology and inflammation. The merger also brought INTEGRILIN® (eptifibatide) Injection, a market-leading intravenous anti-platelet drug for patients with severe cardiovascular diseases, into the Millennium fold. Later in 2005, the Company sold the rights to Schering-Plough.

Launching and Expanding VELCADE

As Millennium celebrated its tenth anniversary in 2003, the Company reached new heights. VELCADE® (bortezomib) for Injection was launched in May of that year for the treatment of relapsed and refractory multiple myeloma – a cancer of the blood. In June 2008, the VELCADE label was expanded to include previously untreated multiple myeloma. VELCADE also is approved to treat patients with mantle cell lymphoma, who have received at least 1 prior therapy. You should not receive VELCADE if you are allergic to bortezomib, boron, or mannitol. VELCADE must not be administered into your spinal fluid (intrathecally). VELCADE is the first FDA-approved proteasome inhibitor and reached the market in record time. It represented the first treatment in more than a decade to be approved for patients with multiple myeloma.

Read the VELCADE Important Safety Information. Read the VELCADE Full Prescribing Information. This information is intended for US residents only.

VELCADE is currently approved in more than 90 countries worldwide, including the US, European Union and a number of countries within Latin America and Southeast Asia. VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, LLC. Millennium is responsible for commercialization of VELCADE in the US. Janssen Pharmaceutical KK and Takeda Pharmaceutical Company Limited are responsible for commercialization in Japan, and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world.

Focusing on Our Future

Today, Millennium has a leading oncology product, proven commercial capabilities and many product candidates in varying stages of development. We are continually evolving to ensure that our research and development efforts stay current with the demand for new therapeutic products that will make a genuine difference in patients' lives.

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Business Highlights

December 1993

Millennium Enters Market

Millennium Pharmaceuticals, Inc. enters market as a genomics company

Business Highlights

May 1996

Nasdaq Listing

Listing on Nasdaq as MLNM

Scientific and Regulatory Highlights

May 2003

FDA Approves VELCADE® (bortezomib) for Injection

FDA Approves VELCADE for Relapsed/Refractory Multiple Myeloma patients who have received at least 2 prior therapies*

Business Highlights

June 2003

VELCADE Inception

Agreement with Johnson & Johnson's Ortho Biotech unit to co-develop and market VELCADE outside of US*

Scientific and Regulatory Highlights

April 2004

VELCADE in Europe

EMEA grants approval to market VELCADE in Europe for treating patients with relapsed/refractory MM*

Business Highlights

June 2004

INTEGRILIN (eptifibatide) Injection

Agreement with GlaxoSmithKline in Europe for INTEGRILIN Injection

Industry Awards

August 2004

VELCADE Awarded

Oncology Compound of the Year for VELCADE — Pharmaceutical Achievement Awards, IBC Life Sciences*

December 2004

Company Accolades

Top 100 Innovators list — Red Herring Magazine Most Admired Healthcare Companies list — Medical Advertising News Top Employers list — Science magazine

Scientific and Regulatory Highlights

March 2005

Additional VELCADE Approval

FDA approved VELCADE for the treatment of MM after 1 prior therapy*

Industry Awards

June 2005

VELCADE Awarded

VELCADE won the International Prix Galien award (June 2005 in France, the Netherlands and Belgium; September 2005 in Germany and April 2006 in Switzerland)*

Business Highlights

July 2005

New Leadership

Deborah Dunsire, M.D., new President and CEO

July 2005

INTEGRILIN® Injection Rights Sold

Rights for INTEGRILIN Injection sold to Schering-Plough

Scientific and Regulatory Highlights

December 2006

Additional VELCADE Approval

FDA approval of VELCADE for the treatment of Mantle Cell Lymphoma after 1 prior therapy*

Scientific and Regulatory Highlights

April 2007

Genomic Research

Discovery of biomarkers predictive of response to VELCADE in MM patients, highlighting applicability of genomic research to personalized medicine*

October 2007

VELCADE Label Addition

Instructions for use of VELCADE in patients with impaired kidney function, including those on dialysis, added to label*

Industry Awards

June 2008

Best Place to Work

Best Places to Work – The Scientist's annual survey – ranked fourth

September 2008

Corporate Citizen

Corporate Citizen of the Year – Cambridge, Massachusetts Chamber of Commerce

October 2008

Top Employer

Top Employers in the Biotech/Pharma Industry — First time in  Science magazine's top 10 annual survey

Business Highlights

January 2008

Strategic Partnership

Strategic partnership begins with Harvard Medical School

May 2008

Millennium Acquired

New name — Millennium: The Takeda Oncology Company in acquisition by Takeda Pharmaceutical Company Limited. Millennium ceases trading on Nasdaq.

Scientific and Regulatory Highlights

June 2008

Additional VELCADE Approval

Vista Frontline Data Expands Indication to the Treatment of Multiple Myeloma*

August 2008

VELCADE Study Published

New England Journal of Medicine publishes VISTA study showing VELCADE for Injection improves overall survival of patients with multiple myeloma (MM) at 16.3 month median follow up*

Business Highlights

June 2009

IDM Pharma Acquired

Takeda acquires IDM Pharma and the commercialization rights to mifamurtide

December 2009

Strategic Partnership

Millennium and Seattle Genetics announce strategic partnership on the worldwide development and commercialization of SGN-35

Scientific and Regulatory Highlights

December 2009

VELCADE Label Updated

FDA updates VELCADE label to include 3-year VISTA Overall Survival Benefit*

Industry Awards

July 2010

Sales Team Recognition

Health Strategies Group recognizes the Millennium Sales Team as leading the industry in relationship value with Oncologists

Proteasome

A distinct enzyme complex within cells responsible for breaking down proteins that have been marked for disposal by the attachment of a tag called ubiquitin, including regulatory proteins governing processes such as cell division.

Genomics

The study of genetic material in the chromosomes of a particular organism and its activity.

Indications and Important Safety Information for VELCADE® (bortezomib)

What is VELCADE used for?

VELCADE (bortezomib) is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of the lymph nodes) who have already received other treatments.

How is VELCADE administered?

VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. It is administered by a healthcare professional as an injection into your vein (intravenously, or IV) or under your skin (subcutaneously). VELCADE must not be administered into your spinal fluid (intrathecally).


Who should not receive VELCADE?

Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. You should not receive VELCADE if you are allergic to bortezomib, boron, or mannitol.

What are the possible side effects of VELCADE?

VELCADE (bortezomib) can cause serious side effects, including:

  • Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. Tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE or stop it altogether. If you have peripheral neuropathy before starting VELCADE, your doctor could consider giving you VELCADE subcutaneously.

  • Low blood pressure. VELCADE can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy, or feel as though you might faint. If you are taking drugs that lower blood pressure, your medications might need to be adjusted. If you are not drinking enough liquids, your doctor may need to administer IV fluids.

  • Heart problems. Treatment with VELCADE can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. Tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.

  • Lung problems. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. Tell your doctor if you experience any cough, shortness of breath, wheezing, or difficulty breathing.

  • Liver problems. If you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease.

  • Posterior reversible encephalopathy syndrome (PRES). There have been reports of a rare, reversible condition involving the brain, called PRES, in patients treated with VELCADE. Patients with PRES can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems. Treatment with VELCADE should be stopped in cases of PRES.

  • Gastrointestinal problems. VELCADE (bortezomib) treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.

  • Neutropenia (low levels of neutrophils, a type of white blood cell). VELCADE can cause low levels of white blood cells (infection-fighting cells). If your white blood cells become low, you can be at higher risk for infections. Tell your doctor if you develop a fever or believe you have an infection.

  • Thrombocytopenia (low levels of platelets). VELCADE can cause low levels of platelets (clot-forming cells). If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion.

    You will have regular blood tests to check your cell counts during your treatment with VELCADE. If the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE.

  • 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. TLS can occur with cancer treatments, and your doctor will be monitoring your blood and urine for any signs of this syndrome. If you develop TLS, your doctor will take appropriate steps to treat it.

More than 1 in 5 patients (20%) receiving VELCADE have experienced the following side effects: nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia (nerve pain), anemia, leukopenia (low levels of white blood cells), constipation, vomiting, lymphopenia (low levels of a certain type of white blood cells), rash, pyrexia (fever), and anorexia.

What other information should you discuss with your doctor?

Women should avoid becoming pregnant or breast-feeding while being treated with VELCADE (bortezomib). Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.

You should also tell your doctor if you:

  • Have kidney disease. If you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
  • Are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
  • Have liver disease.
  • Are using any other medications, including prescription and over-the-counter drugs, herbal or dietary supplements, or holistic treatments. St. John’s wort should be avoided.
  • Develop a rash of any type while receiving VELCADE.

The side effects of VELCADE may impair your ability to drive or operate machinery.

These are not all of the possible side effects with VELCADE. It is important to always contact your doctor if you experience any side effects while on VELCADE. If you have any questions about VELCADE, contact your doctor. Additional information is available on the Web site VELCADE.com.

Please see the full Prescribing Information for VELCADE, including Warnings and Precautions.