UCB and Immunomedics announce worldwide development collaboration and license agreement for Epratuzumab
Brussels, Belgium and Morris Plains, New Jersey, May 10, 2006 - UCB (Euronext Brussels: UCB), a leading global biopharmaceutical company, and Immunomedics, Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on developing therapeutic monoclonal antibodies, today announced a collaboration and license agreement for Immunomedics’ lead product, epratuzumab. The agreement grants UCB the exclusive worldwide rights to develop, market and sell epratuzumab for all autoimmune disease indications. Epratuzumab’s most advanced program is for the treatment of Systemic Lupus Erythematosus (SLE): it has been granted FDA Fast Track designation and is currently undergoing two phase III clinical trials.
Immunomedics will receive initial cash payments totaling 38 million U.S. dollars over the next 10 business days and could receive potential regulatory milestone payments of up to 145 million U.S. dollars in cash and 20 million U.S. dollars in equity investments, depending on geography approval and approval in different indications over several years. In addition to receiving royalties on sales, Immunomedics could also receive sales bonuses upon reaching certain sales target levels.
“We are pleased to enter into this collaboration with Immunomedics, a focused monoclonal antibody research and bio-manufacturing company. Epratuzumab is a promising molecule which we expect to complement our existing portfolio in autoimmune and inflammatory diseases. It offers a unique mechanism of action in targeting B-cells which is very complementary to UCB’s T-cell expertise. UCB plans to escalate activity in the ongoing Phase III studies, with timelines and milestones to be updated when fully integrated into our existing portfolio. The focus during our evaluation of epratuzumab was on autoimmune indications, driven by the very compelling clinical data in SLE, and our interest in furthering the molecule in this and other autoimmune diseases,” said Melanie Lee, Executive Vice President Research & Development of UCB.
“We are excited to collaborate with UCB, since they have demonstrated leadership in the development of monoclonal antibodies. We believe that they are well suited to optimize the potential of epratuzumab in multiple autoimmune disease indications,” commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. “Furthermore, our business strategy of out-licensing compounds in late stage clinical development for markets with unmet medical needs fits exceedingly well with UCB’s focus on securing leading positions in severe disease categories through its successful worldwide marketing and sales organisation. We look forward to bringing epratuzumab to patients with autoimmune disorders through this collaboration,” she added.
Epratuzumab, a humanized monoclonal antibody against the CD22 marker expressed on activated B-cells, was developed and manufactured internally at Immunomedics, and is covered by worldwide patent estate. It is Immunomedics’ lead product candidate being evaluated in two international pivotal Phase III (“ALLEVIATE A and B”) trials for the treatment of moderate and severe SLE. The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE, following Immunomedics’ completion of a Phase II trial.
About Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is a complex systemic autoimmune disease of unknown etiology characterized by cellular and humoral defects, resulting in a breakdown of immunological tolerance and production of auto antibodies to a broad spectrum of nuclear antigens. Like other autoimmune diseases, genetic and environmental influences are thought to trigger disease. The clinical findings in SLE vary greatly and may begin abruptly with fever simulating acute infection or may develop over months or years with periodic episodes.
Incidence of SLE is thought to vary between 24-65 cases per 100,000 people in the US and EU, although some reports from the USA suggest a much higher incidence. The disease has a gender bias and principally affects women (90%).
UCB (www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing over 8,500 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange with a market capitalization of approximately 6.0 billion euro. Worldwide headquarters are located in Brussels, Belgium.
Immunomedics is a New Jersey-based biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabelled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We believe that our portfolio of intellectual property, which includes approximately 90 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. Visit our web site at http://www.immunomedics.com. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a new novel dock and lock platform technology, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pre-targeting methods.
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