UCB receives positive CHMP opinion for CIMZIA® (certolizumab pegol) dose dispenser cartridge for use with ava® electronic injection device

• UCB will bring first electronic injection device to rheumatology patients in EU

Brussels, Belgium – April 26, 2017 – UCB has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the CIMZIA dose dispenser cartridge for use with the re-usable ava^® electronic injection device in all approved indications. 

“UCB recognizes the unique and varying needs of people living with immunologic diseases. With our extensive, uniquely tailored portfolio of devices designed in partnership with patients, physicians, and payers, patients now have multiple administration options. Our innovative new e-device, ava^®, gives patients a choice that will improve their treatment experience,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB. “Patients typically have personal preferences for self-injection devices depending on their experience and individual needs. Having an electronic injection device, a pre-filled pen, and a pre-filled syringe for CIMZIA will bring more value to patients.” 

CIMZIA ava^® was studied in 61 UK patients living with rheumatoid arthritis. The results of the research helped to inform the ava® design and ensure safe and appropriate use of the device.¹

CIMZIA ava^® is the first re-usable electronic injection device in rheumatology and includes a number of innovative features.¹ 

It is the only injection device offering the combination of a hidden needle and ability to control the speed of injection.  Currently patients need to either choose a device with a hidden needle, such as a pen, or go for control of speed, such as a syringe. The benefit of both can mean reduced anxiety and a more comfortable injection. 

CIMZIA ava^® also offers step-by-step guidance, increasing patient confidence and reducing errors. A training cartridge included in the ava kit allows patients to practice using the device as much as they need. An on-screen notification of when the next injection is due and injection log helps patients be more active in managing their care, in partnership with their physicians.¹  

Additional safety features include a skin sensor that ensures CIMZIA ava^® is correctly positioned on the patient’s skin. CIMZIA ava^® will not inject unless the skin sensor is in full contact with the skin. The skin sensor minimizes drug wastage by preventing inadvertent or accidental injections.

UCB is committed to providing value to patients and meeting their unique needs. As part of this commitment, UCB continued its partnership with OXO, a company known for thoughtful, consumer friendly designs, to develop the ava^® electronic injection device. 

The CIMZIA ava^® electronic injection device received its CE Mark on March 17, 2016. This certification means that the device meets all safety and quality standards and that it can be marketed in European member states, Switzerland, and Turkey. With the CHMP approval of the dose dispenser cartridge, the device can now be prescribed by healthcare providers in the EU to dispense CIMZIA.

UCB will make ava^® available in the next few months in selected health centers in several European countries. After initial feedback and learnings from the centers, ava will then be introduced to other health centers and countries. The availability of ava will allow UCB to provide multiple administration options for CIMZIA patients. 

The AutoClicks^® Prefilled Pen was approved by CHMP in 2016 for use in countries throughout Europe. The Institute for Universal Design recently presented the CIMZIA^® AutoClicks^® Pre-filled Pen with two UNIVERSAL DESIGN 2017 awards—the Consumer Award, selected by a panel of 100 consumers and the Expert Award, selected by a panel of design experts. These awards recognize products that fulfil the Institute’s aim of promoting the use of design to address challenges affecting society.

About OXO
Founded in 1990 on the concept of Universal Design, OXO's mission is to create consumer household products that ease the tasks of everyday life for the widest range of users possible. Since the original 15 Good Grips items were introduced, the OXO collection has grown to more than 1,000 strong, covering many rooms of the house and tasks including cooking, baking, cleaning, brewing coffee, storing, organizing, childcare and more. Headquartered in New York City, the company’s products are sold in more than 80 countries and are included in the permanent collections of numerous museums. The company has won more than 100 design and business awards worldwide and is frequently used as a case study on how a well-executed Universal Design philosophy can be a successful business strategy. 

OXO and Good Grips^® are trademarks owned and/or licensed by Helen of Troy Limited (NASDAQ, NM: HELE), and are used by UCB under license. 

About CIMZIA^®
CIMZIA^® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. 

REFERENCES
1.    UCB Data on File. 

About Cimzia^® in the EU/EEA
In the EU, Cimzia^® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA 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. CIMZIA^® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia^® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Cimzia^®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia^® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia^® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

• Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
• Axial spondyloarthritis (axSpA) without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.⁴

Important Safety Information about Cimzia^® in the EU/EEA
Cimzia^® was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 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), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (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 oedema, 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, 4.4% of patients discontinued taking Cimzia^® due to adverse events vs. 2.7% 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 cytopaenia, 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 haematological 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.

Cimzia^® was studied in 325 patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30 months and in 409 patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30 months. The safety profile for axSpA and PsA patients treated with Cimzia^® was consistent with the safety profile in RA and previous experience with Cimzia^®.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision 15th December 2016. 
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf   

For further information, UCB: 

Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

Laurent Schots 
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com 

Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com 

Brand Communications

Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.levin@ucb.com 

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 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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