Gina Brazier (investor)
(617) 551-3611
Adriana Jenkins (media)
(617) 761-6996
Millennium Pharmaceuticals, Inc.
Harry A. Arena (investor)
(610) 431-0800 ext 203
Arthur V. Boyce Jr. (media)
(610) 431-0800 ext 259
Targeted Diagnostics and
Therapeutics, Inc.



New Target Builds Company’s Portfolio of Cancer Product Candidates

CAMBRIDGE, Massachusetts, and, WEST CHESTER, Pennsylvania, November 26, 2001— Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) and Targeted Diagnostics and Therapeutics, Inc., (TDT), a privately-held company, today announced that TDT has granted Millennium a license to TDT’s intellectual property surrounding guanylyl cyclase C (GC-C), a protein uniquely expressed on the cell surface of colorectal tumors, and its related ST ligand for use in colorectal cancer therapeutics. Millennium intends to utilize these advanced components to develop both toxin and antibody-based therapeutics directed against colorectal cancer. Due to the utility demonstrated in preclinicial work, Millennium believes there is potential to create highly specific therapies that may offer significantly improved efficacy and safety in the fight against metastatic colorectal cancer.

Under the terms of the agreement, TDT grants Millennium an exclusive worldwide license for development of human cancer therapies targeting GC-C and utilizing the ST ligand. In exchange, Millennium will make an initial equity investment in TDT, as well as pay milestone fees and potential royalties following achievement of specific development goals. Additional financial terms were not disclosed.

“Millennium continues to build our oncology franchise and expand our leadership position by broadening our pipeline of product candidates based on novel disease targets, and acquisition of the GC-C target represents an exciting opportunity for us to address a major area of oncology and a major unmet medical need,” said John Maraganore, Ph.D., senior vice president, strategic product development at Millennium. “We continue to identify the most attractive molecules across the biotechnology landscape through our knowledge of cellular pathways and mechanisms of action, and we believe that GC-C is the most promising new colon cancer target we’ve seen. This license, in addition to collaborations with ImmunoGen and BZL Biologics earlier this year, underscores Millennium’s commitment to building a significant portfolio of cutting-edge cancer therapeutics through a combination of internally-derived, in-licensed and acquired products and capabilities.”

“Current preclinical work with an ST-linked imaging agent has already demonstrated the strong utility of the GC-C target in a diagnostic setting. Based on extensive published research and preclinical studies, we believe the ST ligand also has great potential to provide multiple, highly specific treatment options for colorectal cancer,” said Harry Arena, MBA, President and Chief Executive Officer of Targeted Diagnostics and Therapeutics, Inc. “We believe Millennium is an ideal partner to take the next step in moving GC-C to clinical and commercial applications in colorectal cancer treatment.”

GC-C Target and ST Ligand
Extensive research has demonstrated that GC-C is a receptor that is uniquely expressed in metastatic colorectal tumors, but not normal tissues outside the intestine. The heat-stable enterotoxin peptide (ST) produced by E. coli bacteria uniquely binds to GC-C and this specific interaction becomes a valuable basis for creating novel targeted conjugate drugs that selectively kill only metastatic colorectal cancer, leaving normal cells untouched. By harnessing the specificity of GC-C expression, Millennium can apply its expertise in antibody-based therapeutics and toxin-linked conjugates to develop novel treatments for colorectal cancer. Studies performed to date have demonstrated that GC-C can serve as a highly sensitive and specific target for the delivery of novel imaging agents directed by ST to metastatic human colorectal tumors in a variety of animal models.

Colorectal Cancer
Currently colorectal cancer kills over 50,000 people in the United States every year and is the third most common cancer in both men and women. Although primary colorectal cancer is responsive if diagnosed and treated at an early stage, advanced metastatic colorectal cancer therapies have found to be generally ineffective. Therapeutics based upon GC-C and ST ligand and/or antibody-based technologies may offer a novel, effective and specific treatment for these currently poorly responsive metastatic cancer indications.

Millennium’s Oncology Franchise
Millennium has committed to pursing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise and strategic business development. To this end, Millennium has already produced a deep oncology pipeline that ranges from multiple novel targets to commercialized therapeutic and diagnostic products. Among the most advanced clinical compounds is in LDP-341, a proteasome inhibitor that is currently is in phase II trials for multiple myeloma and chronic lymphocytic leukemia, and in phase I trials for a variety of solid tumors including colon, breast, pancreatic and prostate cancers. Millennium’s oncology pipeline also includes an anti-PSMA antibody currently in phase I clinical trials for advanced prostate cancer. The CAMPATH® (alemtuzumab) monoclonal antibody, a therapeutic developed from a joint venture of Millennium, is on the market in both the United States and a number of European countries for the treatment of certain forms of chronic lymphocytic leukemia, the most prevalent adult form of leukemia. A Millennium alliance partner and licensee is in the process of developing and commercializing Melastatin™, a melastatin detection product developed through our predictive medicine efforts.

Millennium Pharmaceuticals, Inc.
Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Massachusetts, Millennium currently employs more than 1,500 people.

Targeted Diagnostics and Therapeutics, Inc.
TDT is a biotechnology company with a substantial intellectual property portfolio and research commitment in the area of discovery and development of molecular-based technologies for the targeted detection and treatment of cancer, infectious diseases, and gastrointestinal disorders. Since it’s inception in 1994, TDT has been successful in developing highly specific novel diagnostic markers and therapeutic targets for gastrointestinal malignancies including colon, rectal, gastric, pancreatic and esophageal cancer. In addition to the technology for therapeutics targeted to colorectal cancer being licensed to Millennium, TDT is pursuing preclinical testing in animal models of targeted imaging agents for metastatic colorectal cancer. Also, a highly sensitive and specific molecular marker is currently undergoing Phase I human clinical testing for staging patients with colorectal cancer, and for detecting recurrent cancer in the blood of patients undergoing postoperative surveillance for this disease. Headquarters for TDT are located off the Route 202 biotechnology corridor in West Chester, Pennsylvania.

For Millennium: This press release contains “forward-looking statements,” including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause Millennium’s actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; 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 we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Editor’s Note: This release is available on Millennium’s website at