Physicians' Financial News: February 2008

By Matthew Mahady
Published: Wednesday, Jun 23, 2010
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â–º Future Looking Bright for Millennium After Record 2007

Millennium Pharmaceuticals, Inc., driven by the stellar sales and marketshare growth of injectable Velcade (bortezomib), its flagship oncology product, posted record numbers in 2007. With the continued evolution of the promising candidates that crowd a maturing drug development pipeline and the recent release of significant data supporting the prospect of expanded Velcade indications, the company is positioned to match or eclipse its unprecedented 2007 performance.

Background

Millennium, based in Cambridge, Massachusetts, was founded in 1993 and has been a publicly traded company since 1996. The Company's research, development, and commercialization activities are focused in two therapeutic areas: oncology and inflammation.

The company employs over 1,100 people and markets Velcade, a first-in-class small molecule proteasome inhibitor approved in the United States for the treatment of patients with multiple myeloma (MM) and mantle cell lymphoma (the most aggressive source of non-Hodgkin’s lymphoma [NHL]) who have received at least one prior therapy. In addition, the company receives royalties for sales of Integrilin (eptifi- batide) injection, a drug indicated for the treatment of patients with acute coronary syndrome that Millennium had formerly comarketed with Schering-Plough.

The company’s future prospects appear robust. In late December 2007, Millennium announced the submission of a supplemental new drug application (sNDA) with the FDA for Velcade in the treatment of patients with previously untreated MM. The filing is based on data from the 682 patient Phase III VISTA (Velcade as Initial Standard Therapy in MM) trial, one of the largest, international, randomized clinical trials for patients in this treatment setting. "This submission is an important step in expanding the benefits of Velcade therapy from patients with relapsed disease to those with previously untreated MM. We will request a priority review and, if granted, we could expect approval by mid-2008," said Deborah Dunshire, MD, President and CEO, Millennium.

In addition, Millennium boasts a fertile pipeline featuring 11 compounds currently in clinical development. Six of these compounds address various inflammation-related maladies (i.e., rheumatoid arthritis, asthma, atherosclerosis, Crohn’s disease and more), while the other five represent potential oncology therapies. In addition, Millennium is aggressively seeking to expand the range of indication for which Velcade is currently approved, continuing to investigate Velcade globally in Phase I, II and III clinical trials in a diverse array of hematologic and solid tumors, including front-line MM, various forms of NHL and lung cancer.

Research and Development

Millenium’s research and development philosophy is guided by a focus on disease pathways—the networks of molecular mechanisms that underlie serious diseases. “By combining this understanding with knowledge of therapeutically important differences that may exist between patients— differences either in disease pathways or in their responsiveness to particular drugs—we seek to enable ‘personalized medicine’,” commented a Millenium spokesperson. The disease pathway strategy, according to the spokesperson, has yielded several promising experimental drugs currently in development, which include molecules targeted to several key pathways, including the ubiquitin-proteasome pathway, leukocyte activation and migration, and kinase-mediated signaling.

Millennium’s oncology pipeline includes MLN0518, a potential acute myelogenous leukemia (AML) treatment in Phase II testing, and two product candidates MLN8237 and MLN8054 that are currently in Phase I trials for the treatment of advanced malignancies.

Millenium Oncology Pipeline

  Drug Cancer Type
Pre Clinical MLN4924 Advanced malignancies
  MLN2238 Various hematological and solid


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