Millenium Pharmaceuticals
By Roopak Chakravarty
Oct 02, 2007
Millenium Pharmaceuticals hasn't seen its share price move for several years, but that could be about to change. The company's drug for multiple myeloma, Velcade, shows excellent promise and could be a boon for the bottom line. Over the past 90 days, next year's earnings estimates have increased 33%. Analysts expect the company to break even this year and generate a profit of nine cents per share next year.
Full Analysis
Millennium Pharmaceuticals, Inc. (MLNM) is a leading biopharmaceutical company incorporating large-scale genetics, genomics, high throughput screening and informatics in an integrated science and technology platform. This innovative drug discovery platform is applied across the entire research process, from gene identification through patient management, to accelerate and transform the discovery and development of proprietary therapeutic and diagnostic products and services. Millennium is focused on researching and developing treatment for cancer and inflammatory diseases.
Millennium's future lies with Velcade (bortezomib). Velcade is a modified dipeptidyl boronic acid derived from the amino acids leucine and phenylalanine and formulated as a mannitol ester. Millennium received approval on May 13, 2003 in the U.S. (April 27, 2004 in the E.U.) to market Velcade for the treatment of multiple myeloma (MM) patients who have demonstrated disease progression on at least two prior therapies (3rd-line).
Velcade is the only product on the market and the key growth driver for Millennium. Velcade was approved in U.S. (May 2003), EU (April 2004) and Japan (October 20, 2006) as a single agent for the 2nd line or 3rd line treatment of multiple myeloma (MM, also known as myeloma or plasma cell myeloma).
MM is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. MM is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths.
The company plans to file a supplemental new drug application (sNDA) in the U.S. for use of Velcade in patients with newly diagnosed multiple myeloma in the first quarter of 2008, based on the data from this trial, which was conducted under the special protocol assessment (SPA) process with the FDA. The company also expects that these data will be presented at the December 2007 meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
On July 16, 2007, Millennium initiated a randomized, multi-center phase III trial to determine the most effective Velcade based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma (MM) patients, ineligible for stem cell transplantation. |
