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Phase 3 Trial Results of Bortezomib Show Extended Survival in Patients With Relapsed Myeloma

CAMBRIDGE, Mass., May 17 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that in the final survival endpoint analysis in the phase III confirmatory APEX study comparing patients receiving VELCADE to those receiving high-dose dexamethasone, VELCADE produced a statistically significant survival benefit. The study was designed to include survival as a secondary endpoint and allowed crossover for patients experiencing disease progression on high-dose dexamethasone to receive VELCADE. Both the interim data and the final survival analysis from the APEX study will be presented on Sunday, June 6, 2004 at the upcoming American Society of Clinical Oncology (ASCO) meeting in New Orleans, LA.

"We are extremely pleased and enthusiastic about the clear survival advantage demonstrated in this trial," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "This is the first randomized study of a treatment in the relapsed multiple myeloma setting to show a survival advantage over a current standard of care. Further, these data potentially represent a significant opportunity to make an important difference in extending survival for patients living with multiple myeloma."

The confirmatory phase III APEX trial included patients with relapsed or refractory multiple myeloma whose disease had progressed after receiving one to three previous therapies. The study was halted one year early in December of 2003 after a data monitoring committee concluded the findings of a pre- specified interim analysis showed a statistically significant improvement in time to disease progression -- the primary endpoint of the trial -- in patients receiving VELCADE compared to patients receiving high-dose dexamethasone. Patients were randomized to receive either VELCADE or high- dose dexamethasone, a recognized standard of care in this setting. The trial enrolled more than 670 patients in 95 sites in the United States, Canada and Europe. The trial design included a primary endpoint of time to disease progression and secondary endpoints that included measurements of clinical benefit, safety and survival.

About VELCADE(R) (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma -- a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival. On April, 27, 2004, the European Commission granted marketing authorization for VELCADE for the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on their last therapy.

VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development; Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag will be responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.

VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.

In 228 patients who were treated with VELCADE(R) (bortezomib) 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65 percent), nausea (64 percent), diarrhea (51 percent), decreased appetite including anorexia (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent), and nausea (4 percent).

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

Source: Millenium Pharmaceuticals

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