Endgame: nothing short of breakthrough science

Innovative medicines are the only way to go, especially for a small company like Millennium. We are merely a rounding error in some of the bigger companies’ systems. We have to take risks because there are high rewards in unmet medical needs. When you bring a first-in-class molecule to the marketplace, it is really something. It makes a huge difference in the practice of medicine by bringing more options for the patients – options they never had before. A ‘me-too’ will not help you to achieve this.

Personalized medicines

All research and development at Millennium is focused on the goal of developing breakthrough treatments that will make a real difference in patients’ lives. We believe that the best way to accomplish this is to develop a deep understanding of 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”. By this we mean providing the right drugs, directed toward the right molecular targets, to the right patients, at the right time.

Investing in the right technologies

We expect to develop drugs in two key therapeutic areas: cancer and inflammation. To add to our clinical pipeline, we have a large number of discovery-stage and preclinical programs. Our research and drug discovery efforts are now focused solely on oncology small-molecule drug development. We aim to combine world-class biology in important disease pathways with an industry-leading technology platform.

Critical to the success of oncology drugs, particularly in the early development stages, will be imaging technologies, existing ones and those emerging over the next several years – a view shared by others, such as the National Cancer Institute.

We have invested heavily in cell-based screening as well as noninvasive animal imaging. Multi-modal positron emission tomography and magnetic resonance imaging (PET/MRI) in animal models, for example, make a critical connection between research and the clinic by allowing a seamless transition.

Interrogating enzymes in the context of their normal environment is a very powerful approach to underlying biology. We use cellular imaging from high throughput screening all the way through pre-clinical development. Then we utilize the reagents that we have generated to analyze cellular phenotypes as biomarkers in clinical trials.

Leading the game

Millennium has strategic alliances and business partnerships with some of the world’s leading pharmaceutical and biotechnology firms. The relationships range from disease-oriented therapeutic collaborations and technology-transfer arrangements, to marketing and licensing agreements. Millennium is currently the leader in the area of protein homeostasis with our oncology product Velcade, which has been approved in multiple myeloma and mantle cell lymphoma. The rapid clinical development of this drug – with FDA approval granted little more than four and a half years after initiation of the first clinical trial – reflects our commitment to novel treatments for cancer patients.

Velcade has had great clinical success and is the first proteasome inhibitor to be commercialized. We are going to continue to invest in protein homeostasis because we’re very excited about the whole array of targets in this particular field. It offers a great future with many opportunities.

Joseph B. Bolen, Chief Scientific Officer, has spent more than 30 years in the oncology field. He is a recognized world leader in the field of signal transduction and the molecular mechanisms of cancer, and has authored over 180 publications, most notably about the biochemistry and molecular biology of protein tyrosine kinases.

Before joining Millennium in 1999, Bolen was VP of Oncologic Diseases at Hoechst Marion Roussel for one year. Previously, Bolen was Director of the Cellular Signaling Department at the DNAX Research Institute of Molecular and Cellular and Executive Director of Oncology Drug Discovery at the Bristol-Myers Squibb Pharmaceutical Research Institute. Prior to BMS he spent ten years at the National Institutes of Health in Bethesda, Maryland.

Bolen graduated from the University of Nebraska with a B.S. degree in microbiology and chemistry and a Ph.D. in immunology. He pursued post-doctoral training in molecular virology at the Kansas State University Cancer Center where his research was directed towards analysis of the DNA tumor virus, polyoma.