Filter News

Millennium Pharmaceuticals, Inc. (Cambridge, Massachusetts) Release: VELCADE(R) (Bortezomib) For Injection Demonstrated High Single-Agent Response Rates In Newly Diagnosed Multiple Myeloma Patients

Published: Jun 05, 2006

ATLANTA, June 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced new clinical data for the treatment of multiple myeloma (MM) that underscore the potential benefit of using VELCADE upfront in newly diagnosed patients. Data, reported at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta, June 2-6, 2006, showed an overall response rate of 40 percent as a single agent, including a complete response rate of 10 percent. These data provide further rationale for several Phase II studies of VELCADE in combination with other therapies that consistently have shown some of the highest recorded response rates, including complete responses, in the treatment of front-line MM.

(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO)

"These single-agent results further demonstrated that VELCADE may provide a strong foundation for combining with other agents in the treatment of newly diagnosed patients," said Paul Richardson, M.D., Principal Investigator, from the Dana-Farber Cancer Institute in Boston, Mass. "Emerging data such as these offer real hope that we may continue to improve outcomes for multiple myeloma patients, and do so with less toxicity than other approaches, such as those involving cytotoxic chemotherapy and/or high dose dexamethasone."

Single-agent VELCADE (bortezomib) in Previously Untreated Multiple

Myeloma: Results of a Phase II Multicenter Study (Abstract 7504)

The Phase II prospective, single-arm study led by Dr. Richardson assessed the safety and efficacy of VELCADE in 66 patients with untreated, symptomatic MM. Patients received single-agent VELCADE 1.3mg/m2 twice weekly for two weeks every 21 days for eight cycles. Response rates were measured using the Blade criteria. The following results were reported:

* Overall response rate of 40 percent including a complete response rate of 10 percent and a 30 percent partial response rate. * Therapy well tolerated. Side effects included peripheral neuropathy, fatigue and rash, which were mild to moderate in almost all cases. Importantly, no thrombosis was seen and in those patients with peripheral neuropathy, symptoms improved or resolved in 75 percent of cases through dose reduction or after treatment was completed. Growing Body of Evidence

Previous studies in relapsed MM have demonstrated single-agent VELCADE has an unprecedented survival advantage. In newly diagnosed patients, VELCADE based therapies have achieved transplant-like results with overall response rates of up to 95 percent and complete and near complete response rates of up to 43 percent. To date, over 33,000 MM patients have been treated with VELCADE worldwide.

"The results of this study add to the growing body of data that support our aggressive registration strategy to move VELCADE into the front-line MM setting," said Robert Tepper, M.D., President, Research & Development, Millennium. "If interim data from at least one of our three, Phase III front- line trials are strong, there may be an opportunity for early registration. This could potentially double the number of patients who would benefit from VELCADE based regimens."

Millennium and co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) are currently investigating the potential benefit of VELCADE in the treatment of newly diagnosed MM patients, both eligible and ineligible for transplant, in three Phase III registration trials. Interim data from one of the Phase III registration trials are anticipated later this year.

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

VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD). 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.

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 Pharmaceuticals, Inc., a leading biopharmaceutical Company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of

innovative candidate products. The Company's website is http://www.millennium.com .

This press release contains "forward-looking statements," including statements about the Company's growth and development of products. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company's dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company's products; government and third party reimbursement rates; the commercial success of VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward- looking statements, whether as a result of new information, future events or otherwise.

Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com . 1. American Cancer Society, Overview: Multiple Myeloma, 2005, http://www.cancer.org . Contacts: Theresa McNeely (media) Kyle Kuvalanka (investors) (508) 523-9511 (857) 498-0818

Photo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGOMillennium Pharmaceuticals, Inc.

CONTACT: Media: Theresa McNeely, +1-508-523-9511, or Investors: KyleKuvalanka, +1-857-498-0818, both for Millennium Pharmaceuticals, Inc.

Back to news