* Statistically significant* and clinically meaningful differences of the
epratuzumab 600 mg weekly and 1,200 mg every other week dose groups compared
to the placebo group were achieved, with responders rates twice those of
* Treatment differences were observed as early as week 8, with further
improvement to week 12
* Epratuzumab 600 mg weekly was associated with greater BILAG improvement
(from A/B to C/D) than placebo in affected body systems, with particularly
prominent efficacy in cardiorespiratory and neuropsychiatric systems
Rome, June 16th, 2010 - UCB (EURONEXT: UCB) and Immunomedics Inc. (NASDAQ:IMMU)
announced new lupus drug candidate, epratuzumab, provided a significant
reduction in disease activity in patients with moderate to severe active
systemic lupus erythematosus (SLE). Data presented at the European League
Against Rheumatism (EULAR) meeting in Rome from the phase IIb study, EMBLEM(TM),
showed the clinical efficacy of epratuzumab in patients with SLE.
"We are very encouraged by the findings of this new study which demonstrate that
in a patient population with predominantly severe disease activity, epratuzumab
is improving patients' health as quickly as week 12, with the emergence of
improvements as early as week 8," commented lead study investigator Daniel J.
Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine,
UCLA. He added, "In a short study, such as this one, seeing this level of
patient improvement so rapidly is a hopeful sign of the drug's potential to
become an effective new treatment option."
EMBLEM(TM) 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(TM) was a combined response index endpoint
including several indices of SLE disease activity, primarily emphasizing
In the EMBLEM(TM) study, combined responder index rates were numerically
superior in all epratuzumab groups than in the placebo group, reaching
statistical significance in the epratuzumab 600 mg weekly group (P=0.0265*) and
the combined group of all 74 patients who received a cumulative dose of 2,400 mg
(P=0.0239*) during the 12-week treatment cycle. In both these groups, responder
rates were twice those of placebo.
Based on analysis of improvement in BILAG 2004 by body system in EMBLEM(TM),
most patients had symptom reduction or absence of active disease within specific
body systems after treatment with epratuzumab. Efficacy was particularly
prominent in cardiorespiratory and neuropsychiatric systems in which symptom
improvements are often difficult to achieve. This BILAG analysis reported the
results for the BILAG improvement component of the combined response index in
body systems for which a sufficient number of patients per treatment group had
baseline disease activity that allowed an assessment of response. These systems
were: musculoskeletal, mucocutaneous, cardiorespiratory, neuropsychiatric,
constitutional and renal.
"Achieving a BILAG improvement without worsening, especially at an early
timepoint such as week 12, is encouraging, as the BILAG 2004 evaluates nine
different organ systems affected by SLE, including constitutional,
mucocutaneous, neuro-psychiatric, musculoskeletal, cardiorespiratory,
gastrointestinal, ophthalmic, renal and haematological. In lupus, a disease that
has not seen a new drug approved in over fifty years, epratuzumab shows
encouraging signs of being able to improve patient lives in this devastating and
life altering disease." said Kenneth Kalunian, M.D. Associate Director of the
Center for Innovative Therapy, Professor in the Division of Rheumatology,
Allergy and Immunology in the School of Medicine at UCSD.
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. Epratuzumab is an anti-B-cell therapeutic, because of its ability to
modulate B cell function without depleting a large portion of these lymphocytes.
* p values were not adjusted for multiple comparisons
**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.
For further information
Scott Fleming, Global Communications Manager - Immunology
Tel: +44.770.277.7378,firstname.lastname@example.org <mailto:email@example.com>
Michael Tuck-Sherman, Investor Relations, UCB
Richard Simpson, Investor Relations, UCB
Tel: +32.2.559.9494,firstname.lastname@example.org <mailto:email@example.com>
Antje Witte, Investor Relations, UCB
Tel: +32 2559 9414 / +492173481866,firstname.lastname@example.org
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. Under the license agreement, UCB
owns the rights and is responsible for the clinical development, and
commercialization of epratuzumab in all autoimmune disorders including SLE.
In EMBLEM(TM) patients were randomized to 1 of 6 intravenous regimens: placebo
(PBO), epratuzumab cumulative dose (cd) 200, 800, 2400, or 3600 mg in equal
divided doses using 2 every other week (EOW) infusions or epratuzumab cd 2400 mg
delivered as 4 equal infusions 1 week apart. Concomitant oral corticosteroids
(CS) and immunosuppressives (IS) were stable for at least 5 and 28 days,
respectively, prior to first study drug infusion. Primary endpoint was responder
rate on a combined index of clinical disease activity at week 12 (defined as
reduction of all baseline (BL) BILAG 2004 A to B/C/D and BL BILAG B to C/D, no
BILAG worsening in other organ systems, and no deterioration in SLEDAI or
physician global assessment [VAS]), with no CS, IS and antimalarials increase
over BL dose. The study was not powered to detect statistical differences
between treatment arms.
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 whom
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.
UCB, Brussels, Belgium (www.ucb.com <
http://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 more than 9 000 people in over 40 countries, UCB
produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels
Immunomedics (NASDAQ: IMMU) 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. Immunomedics is developing epratuzumab
for the therapy of B-cell hematopoietic tumors, such as non-Hodgkin lymphoma and
acute lymphoblastic lymphoma.
Forward-looking statements - 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 - 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.
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