|Gina Brazier (investor)
Adriana Jenkins (media)
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
FOR RELEASE MONDAY, NOVEMBER 26, 2001 AT 12:00 NOON EST
MILLENNIUM IN-LICENSES NOVEL TARGET FOR COLORECTAL
New Target Builds Companys 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 TDTs
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 weve seen. This license, in addition to collaborations with
ImmunoGen and BZL Biologics earlier this year, underscores Millenniums
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
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.
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
Millenniums 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.
Millenniums 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
its 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
Millenniums 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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Editors Note: This release is available on Millenniums website