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MLMN - Cancer Drug Study - Phase 3 Halted

Independent Committee Recommends Early End to Confirmatory Phase III VELCADE Trial Based on Achieving Statistically Significant Improvement in Primary Endpoint

Monday December 15, 5:25 am ET
-- Data available one year early; comparator arm patients offered immediate access to VELCADE --


CAMBRIDGE, Mass., Dec. 15 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the Company, based on the recommendation of an independent data monitoring committee and the notification of regulatory authorities, is halting the control arm in the phase III APEX trial. This allows patients currently receiving dexamethasone the option to immediately crossover to VELCADE(TM) (bortezomib) for Injection therapy. The findings of a pre-specified interim analysis found 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"The findings provide important insight into a broader patient population, including patients who received only one prior therapy unlike those treated in the phase II SUMMIT registration trial," said Robert Tepper, M.D., president, research and development at Millennium. "Data from this trial were previously scheduled to be available in 2005 and this accelerates our timetable by over a year. We plan to share the results from this study at a medical conference in the first half of 2004."

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. Patients were randomized to receive either VELCADE or high-dose dexamethasone, a recognized standard of care in this setting. The trial has enrolled approximately 670 patients and is being conducted 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. Data on these endpoints were also reviewed by the data monitoring committee and were found to support the primary endpoint and the decision to end the comparator arm.

About VELCADE(TM) (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.

VELCADE is being codeveloped by Millennium and Johnson & Johnson Pharmaceutical Research & Development L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S. and Ortho Biotech Products L.P. and the Janssen Cilag group of companies will be responsible for commercialization in the EU and 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.

In 228 patients who were treated with VELCADE in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). 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.