UCB and Immunomedics announce positive results for epratuzumab phase IIb study in systemic lupus erythematosus (SLE)
- Data from phase IIb dose and regimen-ranging study demonstrate clinically meaningful treatment effect
- Treatment advantage of epratuzumab over placebo reached 24.9% at week 12
Brussels, Belgium & Morris Plains, New Jersey, 27 Aug 2009 - 7:00 AM (CEST) - press release, regulated information - UCB and Immunomedics (NASDAQ: IMMU) announced today top-line results from UCB's Phase IIb clinical study comparing epratuzumab to placebo in patients with systemic lupus erythematosus (SLE, also commonly known as lupus). The data from the 12-week dose and regimen-ranging study demonstrated clinical meaningful treatment effect of epratuzumab over placebo in SLE patients. The 227 patients in this study had moderately (30%) to severely (70%) active disease in multiple organ systems.
The primary efficacy measure was a combined index endpoint, which included several indices of SLE disease activity, primarily emphasizing BILAG* measured improvement. Treatment advantage of epratuzumab over placebo reached 24.9% at week 12.
"Epratuzumab is the most advanced pipeline program in UCB's immunology disease portfolio and the positive results are significant for UCB as we continue to move our antibody based programs ahead", said Roch Doliveux, Chief Executive Officer of UCB. "These results may provide new hope for the hundreds of thousands of people around the world living with SLE as no new treatment has been approved for this life altering disease for over five decades."
UCB is committed to finding treatments for immunological disorders and providing patients with therapeutic options that are effective with minimal adverse effects. In depth analysis of the data is ongoing in preparation of the phase III program.
Epratuzumab, developed by Immunomedics and licensed to UCB for all autoimmune disease indications in 2006, is a humanised anti-CD22 monoclonal antibody with the potential to modulate B cell activity. Although the exact role of CD22 is not fully understood, it is considered to be a negative regulator of B cell function. B cells are known to contribute to SLE by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself, resulting in inflammation and tissue damage.
"We are delighted that this randomized, placebo-controlled, study conducted by UCB demonstrates the activity of epratuzumab in SLE, which has proven to be difficult to treat with currently available drugs," remarked Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, Inc. "Epratuzumab is a unique anti-B cell therapeutic, because of its ability to modulate B cell function without depleting a large portion of these lymphocytes," she added.
* BILAG (British Isles Lupus Assessment Group) is a comprehensive scoring system for assessing both current SLE disease activity and changes in that activity since the patient was last seen.
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Notes to the Editors
Epratuzumab is a humanized anti-CD22 monoclonal antibody under investigation for the treatment of SLE. CD22 is a B cell specific surface protein that is considered to be involved in B cell function. The product was licensed from Immunomedics, Inc., Morris Plains, NJ, USA.
About systemic lupus erythematosus (SLE)
SLE, commonly referred to as lupus, is a chronic and potentially fatal autoimmune disease with a variable and unpredictable course. Antibodies are generated against the body's own nuclear proteins causing the immune system to attack its own cells and tissues resulting in inflammation and tissue damage. This can occur in any part of the body, but most often targets the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system.
Lupus is characterized by periods of flares, or exacerbations, interspersed with periods of improvement or remission. The Lupus Foundation of America estimated that between 1.5-2 million Americans have a form of lupus, 90 percent of which are women. Symptoms and diagnosis occur most often between the ages of 15 and 45. In the U.S., lupus is more common in African Americans, Latinos, Asians, and Native Americans than in Caucasians.
A Lupus Foundation of America survey demonstrated the potential economic impact of the disease, as two of three lupus patients reported a complete or partial loss of their income because they are unable to work due to complications.
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10,000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. Immunomedics has built a pipeline of therapeutic product candidates that utilize several different mechanisms of action.
Forward-looking statements related to UCB
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
Forward looking statements relating to Immunomedics
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.