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Data Demonstrate Potential of Bortezomib for Injection Across Solid and Hematological Cancers

ATLANTA, GA -- June 16, 2006 -- Millennium Pharmaceuticals, Inc. today announced results from additional studies of Velcade (bortezomib) in a variety of cancers, including multiple myeloma, non-Hodgkin's lymphoma and non-small cell lung cancer at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta, GA. Efficacy and safety were reported even in studies of patients with renal impairment.

"The consistently high response rates reported in studies across multiple cancers presented at this meeting emphasize the potential of Velcade to improve outcomes for patients," said Robert Tepper, MD, President, Research & Development, Millennium. "We will continue to build on the role of Velcade as the backbone of therapy in multiple myeloma while driving our clinical development programs in other indications such as non-Hodgkin's lymphoma and lung cancer."

Highlights of the 42 abstracts on Velcade included oral presentations on multiple myeloma (MM), non-Hodgkin's lymphoma (NHL) and non-small cell lung cancer (NSCLC):

Improved Survival Results in Non-Small Cell Lung Cancer

* Results showed a median survival of 11 months compared with the historical 9-month survival seen with gemcitabine and carboplatin, a current standard of care. These survival results are among the highest recorded to date in the Southwest Oncology Group (SWOG). (Abstract 7017)

High Complete Response and Near Complete Response Rates Achieved with Velcade Added to Up-Front Multiple Myeloma Therapy Prior to Tandem Transplants

* Results showed that incorporating Velcade into induction therapy prior to tandem transplants as first step of the Total Therapy 3 regimen, a DT-PACE (dexamethasone, thalidomide, cisplatin, Adriamycin, cyclophosphamide, and etoposide) chemotherapy regimen, induced remarkably high complete response plus near complete response rates reaching 80% at 18 months. (Abstract 7519)

High Single-Agent Response Rates in Newly Diagnosed Multiple Myeloma Patients

* Results of a phase 2 study showed overall response rates (ORR) of 40% including complete response rates (CR) of 10% with Velcade as a single-agent in newly diagnosed patients. These high single-agent response rates underscore why studies of Velcade in combination with other therapies continue to yield some of the highest recorded response rates in the treatment of front-line MM. (Abstract 7504)

Single-Agent Efficacy in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

* Results showed ORR, including CR of 33% with a median duration of response of 9.2 months, and 13.5 months in patients achieving complete response. These data, together with data from other phase 2 studies, will provide the basis for the Company's submission of a supplemental new drug application shortly. (Abstract 7512)

In these studies Velcade was well tolerated and the side effect profile was consistent with previous studies.

Other Velcade abstracts included:

Well Tolerated in Patients with Renal Impairment

* Results of a study of Velcade in patients with mild-to-moderate impaired renal function showed that Velcade was well tolerated at 1.3mg/m2 two times per week every three weeks. Dose reduction was not needed in patients with renal impairment, supporting previous studies that found Velcade could be given safely to patients including those with severe renal failure and those on dialysis. (Abstract 2032)

Achieved Prolonged Disease Control in Multiple Myeloma

* Results of a phase 1V, open-label trial of Velcade as retreatment therapy alone or in combination with other agents showed an average response rate of 50%. Median treatment-free period between the end of the first Velcade treatment and the start of retreatment was 11.1 months. (Abstract 17539)

Inhibited Bone Resorption Markers in Patients in Multiple Myeloma

* In a prospective study of the effects of once weekly Velcade on markers of bone metabolism in patients with multiple myeloma, the bone resorption markers declined by a mean of 32% over baseline values. Velcade may represent an alternative option for MM patients with bone loss over bisphosphonates that can result in destruction of kidney cells and bone loss in the jaw. (Abstract 7548)

Superior to Dexamethasone in Patients Who Had Received Prior Autologous Stem Cell Transplant (ASCT)

* In patients with relapsed/refractory MM, phase 3 international APEX data showed Velcade was superior to dexamethasone in ORR, CR and time to progression (TTP) regardless of patients' prior ASCT status. (Abstract 7546)

ASCT Treatment Velcade dexamethasone

Active in the Treatment of Waldenstrom's Macroglobulinemia (a form of NHL)

* Final data from a National Cancer Institute of Canada (NCIC) phase 2 study of Velcade in previously untreated or treated Waldenstrom's macroglobulinemia showed an ORR of 26% based on both IgM and tumor shrinkage. (Abstract 7543)

In these studies Velcade was well tolerated and the side effect profile was consistent with previous studies.

About Multiple Myeloma
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 45,000 to 50,000 individuals have MM and over 15,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.(1)

About Non-Small Cell Lung Cancer
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women in the United States. Approximately 163,500 deaths will be attributed to lung cancer and 174,470 new cases will be diagnosed in 2006. Of those, 87% will be NSCLC cases. The five-year survival rate for all stages of NSCLC combined is 15%. If NSCLC is diagnosed and treated early with surgery before spreading to the lymph nodes or other organs, the average five-year survival rate improves to 60%. However, it is estimated that only 15% of people with lung cancer are diagnosed at an early stage.(2)

About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(3) The prevalence of NHL is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 11,000 with mantle cell lymphoma. There are approximately 56,400 new cases of NHL diagnosed per year, and 19,000 deaths are attributed to the disease annually.(4),(5)

Mantle cell lymphoma is an aggressive, rapidly progressive subtype of non- Hodgkin's lymphoma that is not curable with standard therapy. Because there is no generally accepted treatment approach and options often are limited, there is a growing need for new therapies.

About Waldenstrom's Macroglobulinemia
Waldenstrom's macroglobulinemia is a type of non-Hodgkin's lymphoma that produces large amounts of an abnormal protein (called a macroglobulin). In some cases, Waldenstrom's macroglobulinemia can become an aggressive lymphoma. It is estimated that about 1,000 to 1,500 people are diagnosed with Waldenstrom's macroglobulinemia each year in the United States. Waldenstrom's macroglobulinemia is named after Jan Waldenstrom, the Swedish doctor who first recognized this condition in 1944.

About Velcade
Velcade is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

Risks associated with Velcade therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with Velcade.

In 331 patients who were treated with Velcade in a phase 3 multiple myeloma study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). Fourteen% of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on Velcade (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea, pneumonia (4%), and vomiting (3%).

Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and 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. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. Velcade is approved in more than 65 countries worldwide. Velcade is also approved in the European Union as a treatment at first relapse.

REFERENCES:
(1) American Cancer Society, Overview: Multiple Myeloma, 2005, http://www.cancer.org
(2) American Cancer Society, ''What is Lung Cancer?'' Available at http://www.cancer.org. Accessed on February 10, 2006
(3) 2005, American Cancer Society, Inc., Surveillance Research.
(4) SEER, SARGA, and Decision Resources (for growth rate) data.
(5) Federico et al., Blood 95(3): 783-789; 2000.


SOURCE: Millennium Pharmaceuticals, Inc.

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