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Millennium Pharmaceuticals, Inc. Release: VELCADE(R) (bortezomib) For Injection Continues To Provide Responses In Several Subtypes Of Non-Hodgkin's Lymphoma

Published: Dec 07, 2004

SAN DIEGO, Dec. 6 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the latest results of several studies evaluating the efficacy and safety of VELCADE in patients with aggressive and indolent subtypes of non-Hodgkin's lymphoma (NHL). These results were reported at the 46th Annual Meeting of the American Society of Hematology (ASH) taking place this week in San Diego, CA.

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

In three separate ongoing phase II studies, the overall response rates with single-agent VELCADE in follicular lymphoma (FL) ranged from 60 to 17 percent and from 54 to 39 percent in mantle cell lymphoma (MCL).

"The promising data presented at ASH reaffirm the activity of VELCADE in mantle cell and follicular lymphoma. These data have led Millennium and our co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. to establish a broad clinical development plan in NHL, including two company-sponsored phase II trials; one evaluating VELCADE as a single agent in mantle cell lymphoma and the second evaluating VELCADE in combination with rituximab in follicular lymphoma," said David Schenkein, M.D., vice president, clinical oncology, Millennium. "These encouraging data also led to a fast track designation for mantle cell lymphoma by the Food and Drug Administration (FDA), and inclusion of VELCADE into the guidelines of the National Comprehensive Cancer Network (NCCN) as a second-line therapy option for mantle cell lymphoma patients."

A multi-center phase II study (abstract #607) sponsored by the National Cancer Institute and led by Owen A. O'Connor, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center in New York showed encouraging single agent activity in FL and MCL. The study involved 52 evaluable patients with NHL, including 15 patients with FL and 26 patients with MCL.

   * In FL the overall response rate was 60 percent, including two complete
     responses or unconfirmed complete responses;

   * In MCL the overall response rate was 54 percent, including five
     complete or near complete responses; and,

   * Adverse events observed were generally manageable and included
     thrombocytopenia, sensory neuropathy and weakness.

"Given the ongoing medical need for new therapies in relapsed and refractory NHL, we continue to be encouraged by the clinical profile of bortezomib in mantle cell and follicular lymphoma as data continue to emerge," said Dr. O'Connor.

Additional studies suggesting a potential role for VELCADE for Injection in the treatment of patients with NHL included:

* A phase II trial of VELCADE in MCL (abstract #608) presented by Andrew Belch, M.D., of the Cross Cancer Institute in Canada involving 28 evaluable patients who were previously untreated or had received up to two prior chemotherapy regimens: - The overall response rate was 46.4 percent, including one unconfirmed complete response, and 12 partial responses; - Patients who had not previously received chemotherapy achieved an overall response rate 46.2 percent, patients who had received previous therapy achieved an overall response rate of 46.7 percent; and, - Adverse events observed were fatigue, diarrhea, neuropathy, myalgia, as well as peripheral edema in newly diagnosed patients presenting with edema. The protocol was amended to exclude patients with preexisting dypsnea, edema or effusion. * A phase II clinical study of VELCADE in patients with relapsed and refractory NHL (abstract #1386) led by Sandra Strauss, M.D., of St. Bartholomew's Hospital in London included 39 evaluable patients with relapsed and refractory NHL: - Of the 18 MCL patients there were one complete response and six partial responses with an overall response rate of 39 percent; - Of the 12 FL patients there were two late responses three months post-treatment (reduction in tumor volumes of 76.7 percent and 56.1 percent) for an overall response rate of 17 percent; and, - Adverse events observed were thrombocytopenia, fatigue, anemia and peripheral neuropathy. About Non-Hodgkin's Lymphoma (NHL)

NHL is the most common hematologic cancer and fifth most common cancer diagnosed in the United States each year. There are approximately 54,000 new cases of Non-Hodgkin's lymphoma diagnosed per year: it is attributed to 19,000 deaths and is the second fastest growing form of cancer in the U.S. According to the American Cancer Society, the incidence of non-Hodgkin's lymphoma has more than doubled since the 1970s. The average age of diagnosis is between 55 and 60.

About VELCADE(R) (bortezomib) for Injection

VELCADE is approved 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 improvement in survival. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

VELCADE(R) (bortezomib) for Injection is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.

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

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

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products.

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; 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.

Editor's Note: This release is available under the Media section on the Company's website at http://www.millennium.com/.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comMillennium Pharmaceuticals, Inc.

CONTACT: Adriana Jenkins (media), +1-617-761-6996, or Gina Nugent(investor) +1-617-551-3611, both of Millennium Pharmaceuticals, Inc.

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