New Data From UCB's Immunology Portfolio Highlighted at 2012 American College of Rheumatology Meeting

ATLANTA and BRUSSELS, Nov. 9, 2012 /PRNewswire/ -- UCB, a global biopharmaceutical company focusing on immunology treatment and research, is proud to announce new data on two compounds in its immunology portfolio for a broad range of rheumatic conditions at the American College of Rheumatology's (ACR) 2012 Annual Scientific Meeting in Washington, D.C., November 10-14. The data include posters and oral presentations on Cimzia® (certolizumab pegol) for the treatment of moderate to severe rheumatoid arthritis in adults, as well as posters and oral presentations on investigational data on certolizumab pegol for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and axSpA without radiographic evidence of AS (non-radiographic axSpA [nr-axSpA]). Data will also be presented on epratuzumab, which is being evaluated for the treatment of systemic lupus erythematosus (SLE).

"At UCB, we remain steadfastly committed to rheumatology and to providing treatments for patients with severe chronic conditions. The multiple data sets we are presenting at this year's ACR meeting highlight our ongoing scientific research in immunology aimed at helping to address the needs of patients living with a broad range of rheumatic diseases," said Carol Satler, MD, Vice President, U.S. Medical Affairs, UCB, Inc. "We are looking forward to the presentation of data investigating the long-term use of Cimzia^® in adult patients with moderate to severe RA, as well as Cimzia^® data on household productivity. Additionally, we are pleased to announce first results in Phase III data for psoriatic arthritis and axial spondyloarthritis."

In the U.S., Cimzia^® is indicated for the treatment of adult patients with moderately-to-severely active RA. In the European Union, Cimzia^® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. Cimzia^® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

Patients treated with Cimzia^® are at an increased risk for developing serious infections that may lead to hospitalization or death.  Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.  Cimzia^® should be discontinued if a patient develops a serious infection or sepsis.  Additional important safety information is included at the end of this press release.

Following is a guide to UCB-sponsored data presentations being held from Sunday, November 11-Wednesday, November 14, 2012.

Cimzia® for Rheumatoid Arthritis

• Oral Presentation Title: Outcomes of Pregnancy in Subjects Exposed to Certolizumab Pegol
  • Monday, November 12, 2012, 2:30 PM - 4:00 PM
  • Presentation Time: 3:15 PM - 3:30 PM
  • Location: Walter E. Washington Convention Center (WCC): Poster Hall (Hall E)

• Presentation Title: Safety Update on Certolizumab Pegol in Patients with Active Rheumatoid Arthritis with Long-Term Exposure
  • Sunday, November 11, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Long-Term Safety and Efficacy of 4-Weekly Certolizumab Pegol in Combination with Methotrexate and as Monotherapy in Rheumatoid Arthritis: 5 Year Results from an Open Label Extension Study
  • Monday, November 12, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Long-Term Benefits of 4-Weekly Certolizumab Pegol Combination and Monotherapy on Household Productivity and Social Participation in Rheumatoid Arthritis: 5 Year Results from an Open Label Extension Study
  • Monday, November 12, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Certolizumab Pegol Plus Methotrexate is Similarly Effective in Active Rheumatoid Arthritis Patients With or Without Secondary Non-Response to TNF Inhibitors: Post-hoc Analysis of a Phase IIIB Trial
  • Monday, November 12, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Clinical Response at 12 Weeks Predicts Long-Term Remission and the Extent of Radiographic Progression in Japanese Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol With and Without Methotrexate Co-Administration
  • Monday, November 12, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Observation of Persistence Rates and Potential Cost Savings Associated with Certolizumab Pegol Treatment for Rheumatoid Arthritis in England, Wales and Northern Ireland Clinical Practice
  • Tuesday, November 13, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Effects of Anti-Tumor Necrosis Factor Agents on the Expansion of T Helper-Type 17 Cells Driven By Lipopolysaccharide-Stimulated Monocytes
  • Tuesday, November 13, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

Investigational Studies of Certolizumab Pegol for Axial Spondyloarthritis (Including Ankylosing Spondylitis and axSpA without radiographic evidence of AS (non-radiographic axSpA [nr-axSpA])

• Oral Presentation Title: Effect of Certolizumab Pegol on Signs and Symptoms of Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 24 Week Results of a Double Blind Randomized Placebo-Controlled Phase 3 Axial Spondyloarthritis Study
  • Sunday, November 11, 2012, 2:30 PM - 4:00 PM
  • Presentation Time: 2:30 PM - 2:45 PM
  • Location: WCC: Ballroom B

• Oral Presentation Title: Effect of certolizumab pegol on inflammation of spine and sacroiliac joints in patients with axial spondyloarthritis: 12 week magnetic resonance imaging results of a Phase 3 double blind randomized placebo-controlled study (RAPID-axSpA)
  • Monday, November 12, 2012, 4:30 PM - 6:00 PM
  • Presentation Time: 5:45 PM - 6:00 PM
  • Location: WCC: 145 A

• Presentation Title: Rapid Improvements in Patient Reported Outcomes with Certolizumab Pegol in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 24 Week Results of a Phase 3 Double Blind Randomized Placebo-Controlled Study
  • Sunday, November 11, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Increased Participation in Daily Activities After 24 Weeks of Certolizumab Pegol Treatment of Axial Spondyloarthritis Patients, Including Patients with Ankylosing Spondylitis: Results of a Phase 3 Double Blind Randomized Placebo-Controlled Study
  • Monday, November 12, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

Investigational Studies of Certolizumab Pegol for Psoriatic Arthritis

• Oral Presentation Title: Effect of Certolizumab Pegol on Signs and Symptoms in Patients with Psoriatic Arthritis with and without Prior Anti-TNF Exposure: 24 Week Results of a Phase 3 Double Blind Randomized Placebo-Controlled Study
  • Wednesday, November 14, 2012, 9:00 AM - 10:30 AM
  • Presentation Time: 9:30 AM - 9:45 AM
  • Location: WCC: Salon B
     
• Presentation Title: Impact of Imputation Methodology on Radiographic Progression Outcomes – 24 Week Results and Sensitivity Analyses of a Phase 3 Double-Blind Randomized Placebo-Controlled Study of Certolizumab Pegol in Patients with Psoriatic Arthritis
  • Sunday, November 11, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

Investigational Studies of Epratuzumab for Systemic Lupus Erythematosus

• Presentation Title: Efficacy and Safety of Epratuzumab in an Open-Label Extension Study
  • Sunday, November 11, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Epratuzumab-treated Systemic Lupus Erythematosus Patients Report Improvements in Health-Related Quality of Life: Final Results from an Open-Label Extension Study
  • Tuesday, November 13, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Limitations of Current Treatment of Systemic Lupus Erythematosus: A Patient and Physician Survey
  • Tuesday, November 13, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Targeting of CD22 by Epratuzumab Potentially Raises the Threshold of B Cell Receptor Activation
  • Tuesday, November 13, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

• Presentation Title: Phosphoprotein Changes Induced with Epratuzumab, an Antibody Targeting CD22 on B Cells
  • Tuesday, November 13, 2012, 9:00 AM - 6:00 PM
  • Location: WCC: Poster Hall (Hall B)

About Rheumatoid Arthritis (RA)
RA affects more than 1.3 million Americans, and it is estimated that 5 million people suffer from RA globally. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 40-60 years of age.

About Spondyloarthritis (SpA)
SpA is the overall name of a family of inflammatory rheumatic diseases that can affect the spine and joints, ligaments and tendons. There are two main types of clinical presentation of SpA – axSpA (symptoms predominantly related to the spine) and peripheral SpA (symptoms predominantly related to the peripheral joints).

About Ankylosing Spondylitis (AS)
AS is a chronic inflammatory rheumatic disease of the spine and is the most defined subset of axSpA. The symptoms of AS can vary, but most people experience back pain and stiffness due to inflammation which can proceed to fusion of the vertebrae. The condition can be severe, with around 1 in 10 people at risk of long-term disability. The condition usually occurs between 15 and 35 years of age, and rarely starts in old age, with prevalence estimated to be between 0.1% - 1.1% of the population. AS is more common in men than in women.

About Axial Spondyloarthritis (axSpA) without radiographic evidence of AS
Patients with no definitive sacroiliitis on conventional radiographs, but who are showing either sacroiliitis on MRI or are HLA-B27 positive, have axSpA without radiographic evidence of AS (non-radiographic axSpA [nr-axSpA]).

About Psoriatic Arthritis (PsA)
PsA is a condition involving joint inflammation that usually occurs in combination with a skin disorder called psoriasis. Signs and symptoms of PsA include stiff, painful joints with warmth and swelling in the joints and surrounding tissues. In the U.S. it is estimated that PsA affects an estimated 24 in 10,000 people. Between 5 and 10 percent of people with psoriasis develop psoriatic arthritis, according to most estimates, with some studies suggesting a figure as high as 30 percent.

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.

About Cimzia^®
Cimzia^® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia^® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia^® for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia^® in combination with MTX is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia^® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia^® in other autoimmune disease indications. Cimzia^® is a registered trademark of UCB PHARMA S.A.
Please visit www.cimzia.com for full prescribing information for CIMZIA^®.

IMPORTANT SAFETY INFORMATION

Risk of Serious Infections and Malignancy
Patients treated with CIMZIA are at an increased risk for developing serious infections that may lead to hospitalization or death.  Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.  CIMZIA should be discontinued if a patient develops a serious infection or sepsis.  Reported infections include:

• Active tuberculosis, including reactivation of latent tuberculosis.  Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease.  Patients should be tested for latent tuberculosis before CIMZIA use and during therapy.  Treatment for latent infection should be initiated prior to CIMZIA use. 
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.  Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease.  Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.  Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.  Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.  CIMZIA is not indicated for use in pediatric patients.

Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.  Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers.  Patients have frequently presented with disseminated rather than localized disease.

Treatment with CIMZIA should not be initiated in patients with an active infection, including clinically important localized infections. CIMZIA should be discontinued if a patient develops a serious infection or sepsis.  Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteroids or methotrexate) may be at a greater risk of infection.  Patients who develop a new infection during treatment with CIMZIA should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated.  Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

Malignancies
During controlled and open-labeled portions of CIMZIA studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of CIMZIA for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients.  In CIMZIA RA clinical trials (placebo-controlled and open label) a total of three cases of lymphoma were observed among 2,367 patients.  This is approximately 2-fold higher than expected in the general population.  Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy </=18 years of age), of which CIMZIA is a member.  Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma, while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.  Most of the patients were receiving concomitant immunosuppressants. 

Cases of acute and chronic leukemia have been reported with TNF-blocker use.  Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.

Heart Failure
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. CIMZIA has not been formally studied in patients with CHF. Exercise caution when using CIMZIA in patients who have heart failure and monitor them carefully.

Hypersensitivity
Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA administration. If such reactions occur, discontinue further administration of CIMZIA and institute appropriate therapy.

Hepatitis B Reactivation
Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating CIMZIA therapy. Exercise caution in prescribing CIMZIA for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue CIMZIA and initiate effective anti-viral therapy with appropriate supportive treatment.

Neurologic Reactions
Use of TNF blockers, including CIMZIA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA. Exercise caution in considering the use of CIMZIA in patients with these disorders.

Hematologic Reactions
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA. Consider discontinuation of CIMZIA therapy in patients with confirmed significant hematologic abnormalities.

Drug Interactions
An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept.  Formal drug interaction studies have not been performed with rituximab or natalizumab; however because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA in these combinations.  Therefore, the combination of CIMZIA with anakinra, abatcept, rituximab, or natalizumab is not recommended.  Interference with certain coagulation assays has been detected in patients treated with CIMZIA. There is no evidence that CIMZIA therapy has an effect on in vivo coagulation. CIMZIA may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

Autoimmunity
Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.

Immunizations
Do not administer live vaccines or live-attenuated vaccines concurrently with CIMZIA.

Adverse Reactions
In controlled Crohn's clinical trials, the most common adverse events that occurred in >/=5% of CIMZIA patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in >/= 3% of patients taking CIMZIA 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo), hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo), back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo), pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute bronchitis (3% CIMZIA,1% placebo), fatigue (3% CIMZIA, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls.  These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs.  Patients receiving CIMZIA 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200mg every other week.  The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA and 2.5% for placebo.

For full prescribing information, please go to: http://www.cimzia.com/pdf/Prescribing_Information.pdf

Cimzia® (certolizumab pegol) in EU/ EEA important safety information

Cimzia® was studied in 2367 patients with RA in controlled and open label trials for up to 57 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritis (any sites), hepatitis (including hepatic enzyme increase), injection site reactions and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic edema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 5% of patients discontinued taking Cimzia® due to adverse events vs. 2.5% for placebo.
Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate to severe heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia®. Treatment with Cimzia must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia® if infection becomes serious.  Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia®.

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. Carriers of HBV who require treatment with Cimzia® should be closely monitored and in the case of HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 
TNF antagonists including Cimzia® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia® should be discontinued and appropriate therapy instituted. 

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®. 

Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia®. Consider discontinuation of Cimzia® therapy in patients with confirmed significant hematological abnormalities.

The use of Cimzia® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia® should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia® should be closely monitored for infections.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision June 2012.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

For further Information:
Andrea Levin, Associate Director, U.S. Communications and Public Relations, UCB
770.970.8352, [email protected]

Eimear O'Brien, Director, Brand Communications, UCB
+32.2.559.9271, [email protected]

Antje Witte, Investor Relations, UCB
+32.2.559.9414, [email protected]

France Nivelle, Global Communications, UCB
+32.2.559.9178, [email protected]

About Epratuzumab
Epratuzumab is being developed for the treatment of moderate to severe systemic lupus erythematosus (SLE). It is a humanized monoclonal antibody targeting CD22, a B cell-specific protein. CD22 is considered to be a regulator of B-cell function and these cells are known to contribute to SLE by over-reacting and producing antibodies against the body's own cells and tissues.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).

Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially 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, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

References

1. Rheumatoid Arthritis, National Institute of Arthritis and Musculoskeletal and Skin Diseases. Accessed September 25, 2012 from http://www.niams.nih.gov/Health_Info/Rheumatic_Disease/default.asp.

2. Rheumatoid Arthritis, UCB. Accessed September 25, 2012 from http://www.ucb.com/patients/conditions/immunology-inflammation/ra

3. Rheumatoid Arthritis, Mayo Clinic. Accessed September 25, 2012 from http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020.

4. Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis, European Medicines Agency. Accessed September 25, 2012 from www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003424.

5. Ankylosing Spondylitis, National Health Service (NHS). Accessed September 25, 2012 from http://www.nhs.uk/conditions/Ankylosing-spondylitis/Pages/Introduction.aspx.

6. The Assessment of SpondyloArthritis International Society (ASAS) Handbook:

A Guide to Assess Spondyloarthritis, Assessment of SpondyloArthritis International Society (ASAS).  Accessed September 25, 2012 from http://www.asas-group.org/education.php?id=01.

7. Psoriatic Arthritis, Genetics Home Reference.  Accessed September 25, 2012 from http://ghr.nlm.nih.gov/condition/psoriatic-arthritis.

8. What is Lupus, Lupus Foundation of America. Accessed September 25, 2012 from http://www.lupus.org/webmodules/webarticlesnet/templates/new_learnunderstanding.aspx?articleid=2232&zoneid=523.

9. Systemic Lupus Erythematosus (Lupus), John Hopkins Medicine. Accessed September 25, 2012 from http://www.hopkinsmedicine.org/healthlibrary/conditions/arthritis_and_other_rheumatic_diseases/systemic_lupus_erythematosus_lupus_85,P00058/.

10. Lupus Health Center, WebMD. Accessed September 25, 2012 from http://lupus.webmd.com/guide/lupus-systemic-lupus-erythematosus-topic-overview.

11. Sanz I., Eun-Hyung Lee F. B cells as therapeutic targets in SLE. Rheumatology; Vol. 6. 2010; Pp 326-327

12. Walker J., Smith K. B cells as therapeutic targets in SLE. Immunology; Vol. 123. 2008; Pp 314-325

SOURCE UCB

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