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Published on 25 June 2010

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Epratuzumab data from phase IIb EMBLEM study

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UCB and Immunomedics Inc. today announced that data for lupus drug candidate, epratuzumab, were presented at the 9th International Congress on Systemic Lupus Erythematosus in Vancouver, Canada.

These data showed that, in patients with moderate to severe systemic lupus erythematosus (SLE), epratuzumab provided clinically meaningful and statistically significant* improvements in disease activity. In the second half of 2010, UCB will initiate two Phase III studies of epratuzumab for the treatment of patients with moderate to severe lupus.

The presented data, followed by key conclusions, are listed below:

“Epratuzumab Demonstrates Clinically Meaningful Improvements in Patients with Moderate to Severe Systemic Lupus Erythematosus (SLE): Results from EMBLEM, a Phase IIb Study [Oral presentation on Friday June 25th. Session: CS6.3 – NEW DRUGS IN DEVELOPMENT (13:30-15:30)]:

Key conclusion – Epratuzumab (cumulative dose 2400 mg) demonstrated clinically meaningful and statistically significant* improvements in disease activity in patients with moderately to severely active SLE at 12 weeks, with responder rates twice those of placebo. Results validate the combined index emphasizing BILAG and support phase III trials of epratuzumab in SLE.

“BILAG-Measured Improvement in Moderately and Severely Affected Body Systems in Patients with Systemic Lupus Erythematosus (SLE) by Epratuzumab: Results from EMBLEM, a Phase IIb Study” [Oral presentation on Friday June 25th. Session: CS6.4 – NEW DRUGS IN DEVELOPMENT (13:30-15:30)]:

Key conclusion – Treatment with epratuzumab 600mg weekly x4 (for a cumulative dose of 2400 mg) during a 12-week cycle provided greater BILAG improvement over placebo in disease activity in all affected body systems. Efficacy was particularly prominent in cardiorespiratory and neuropsychiatric systems in which symptom improvements are often difficult to achieve. Within specific body systems, the majority had symptom reduction or absence of active disease after treatment. This analysis supports that epratuzumab may be an effective treatment for SLE.

EMBLEM was a 12-week, multicenter, phase IIb, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of epratuzumab, and to define a dose and regimen in patients with moderate to severe SLE. The primary efficacy measure in EMBLEM was a combined response index endpoint including several indices of SLE disease activity, primarily emphasizing BILAG**.

Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.

Epratuzumab is a humanised monoclonal antibody targeting CD22 and modulating B cell activity. Although the exact role of CD22 is not fully understood, it is considered to be a 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.

Data accepted for presentation at this congress also include:

“The effects of the anti-CD22 monoclonal antibody epratuzumab on peripheral blood B cells and immune responses in vivo and immunoglobulin production in vitro” [Oral presentation on Friday, June 25, 2010. Session: CS5.4 – B CELLS IN LUPUS (10:00-11:30)]:

Key conclusion – Epratuzumab treatment caused a reduction in B cells but had no effect on the capacity to raise an antibody response to challenge antigens in animal models.  The production of immunoglobulin by B cells in culture was also unaffected by epratuzumab. Although not yet tested clinically, this might indicate that the efficacy of epratuzumab in SLE patients is unlikely to be accompanied by a gross effect on the capacity to generate an adaptive immune response.

“The effects of the anti-CD22 monoclonal antibody Epratuzumab on B cell surface proteins [Poster presentation on Friday, June 25th. Session: PO1.I – IMMUNOLOGY- B CELLS (11:30-13:30)]:

Key conclusion – Epratuzumab stimulated rapid internalisation of its target, CD22, on human peripheral blood B cells in vitro but had no consistent effect on a range of other B cell markers.  This could lead to modulation of B cell functional responses that are regulated specifically by CD22, which may be relevant in the context of SLE.

“Impact of lupus on patients’ employment, family relationships, and overall wellbeing” [Poster presentation on Friday, June 25th, 2010. Session: PO1.F-EPIDEMIOLOGY [(11:30-13:30)]:

Key conclusion – These results indicate that people affected by lupus experience frequent symptoms which they identify as flares, with a significant impact on employment, physical well-being and everyday living. Fatigue, joint and muscle pain, and skin disorders are the most common physical symptoms reported, and may have a high impact on quality of life regardless of current standards of care. Most patients with lupus are not satisfied with the effects of the treatments they are taking, and place a high priority on communications with family, friends and healthcare professionals.

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