First Patient Receives Cimzia(R) Dose through CIMplicity(TM) within Two
Days of FDA Approval
ATLANTA, April 24 /PRNewswire/ -- UCB announced today the launch of its CIMplicity(TM) program, designed to enhance treatment support for patients suffering from moderate to severe Crohn's disease. CIMplicity(TM) provides Cimzia(R) patients and their caregivers with comprehensive financial, administrative, compliance and treatment support. The U.S. Food and Drug Administration (FDA) approved Cimzia(R) for adult patients with moderate to severe Crohn's disease who have an inadequate response to conventional therapy on April 22, 2008.
"CIMplicity(TM) was developed by UCB to enhance the Crohn's patient experience by providing comprehensive treatment support to patients receiving Cimzia(R)," said David Robinson, vice president and general manager, UCB. "With the introduction of CIMplicity(TM), our goal is to eliminate some of the issues patients face when managing the treatment of a complex and debilitating condition."
Accelerating Access to Treatment
Just two days after approval, David Rubin, M.D. co-director of the Inflammatory Bowel Disease Center at the University of Chicago Medical Center, administered the first dose of Cimzia(R) and enrolled the first patient, Donna Bynes, in the CIMplicity(TM) program. Bynes, a 29-year old nurse from the Chicago suburbs, diagnosed with Crohn's at age 12, has had to discontinue a number of Crohn's medications over the years for a variety of reasons. Bynes received the first dose of Cimzia(R) in Dr. Rubin's clinic and, as part of the CIMplicity(TM) program, will receive the next three doses through the Cimzia(R) free trial program. Through CIMplicity(TM), Bynes also has the option of having Cimzia(R) shipped directly to her home to be administered by a licensed home health nurse, at no additional cost to her.
"Crohn's disease is a chronic condition often diagnosed in young adults at a time when individuals are making education, career and relationship decisions that will affect the rest of their lives," said Dr. Rubin. "There are many needs for those who suffer from Crohn's disease, and Cimzia(R) is a very important new option for these patients. Furthermore, in an era of challenges for providing care, we anticipate that the CIMplicity(TM) program will help to ensure that people like Donna will be able to focus on important life experiences and not on the burden of managing their treatment."
How CIMplicity(TM) Works
Enrollment in CIMplicity(TM) is easy. The health care professional faxes two simple forms to the service center. Once enrollment is complete, a customer service representative will contact the patient to describe the CIMplicity(TM) services, explain insurance coverage and answer any questions. The CIMplicity(TM) service center will then coordinate expedited delivery of Cimzia(R) either directly to the healthcare provider or to the patient's home to be administered by a licensed home health nurse.
CIMplicity(TM) Financial Support Program
The CIMplicity(TM) financial support program includes a free trial program and co-pay assistance (CIMpay(TM)). The free trial program provides patients with up to three doses at no cost to them. Additionally, CIMpay(TM) is available to eligible patients and covers co-pay expenses of up to $500 per month.
In-Home Nurse Support
If a patient chooses to receive Cimzia(R) at home, the free trial doses and/or subsequent shipments can be administered by a licensed home health nurse, coordinated by the CIMplicity(TM) program at no additional cost to the patient. The nurses are trained to answer questions about Crohn's disease and will provide the patient's physician with ongoing updates on progress and patient concerns. Patients will also have access to an adherence nurse and a customized communication plan to facilitate optimal compliance.
CIMplicity(TM) Enrollment is Simple
To enroll, patients and physicians can contact the CIMplicity(TM) service center at 1-866-4-CIMZIA [1-866-424-6942]. For more information on Cimzia(R), log onto http://www.cimzia.com.
Eric Miller, Director, U.S. Communications & Public Relations, UCB Group T +1.770.970.8569, Eric.Miller@ucb-group.com
About Cimzia(R) (certolizumab pegol)
Cimzia(R) is the first and only PEGylated anti-TNF (Tumor Necrosis Factor alpha). Cimzia(R) 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. UCB is developing Cimzia(R) in Crohn's Disease, RA and other autoimmune disease indications. For additional information, including safety information, please refer to the Cimzia(R) factsheet in the "News" section of UCB's website (http://www.ucb-group.com).
About Crohn's Disease
Crohn's disease is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). If not effectively treated, it results in the need for surgery. Crohn's disease has been estimated to affect as many as half a million Americans. People with Crohn's can experience an ongoing cycle of flare-up and remission throughout their lives. Together with ulcerative colitis, Crohn's disease is an inflammatory bowel disease (IBD).
IMPORTANT SAFETY INFORMATION
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving Cimzia(R). Some of these infections have been fatal. Anti-tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of reactivation in patients receiving treatment with TNF blockers such as Cimzia(R). However, active tuberculosis has developed in patients receiving Cimzia whose tuberculin test was negative. Evaluate patients for tuberculosis risk factors and test for latent tuberculosis infection prior to initiating Cimzia(R) and during therapy. Initiate treatment of latent tuberculosis infection prior to therapy with Cimzia(R). Monitor patients receiving Cimzia(R) for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. Consider anti-tuberculosis therapy prior to initiation of Cimzia(R) in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Serious infections, sepsis, and cases of opportunistic infections, including fatalities, have been reported in patients receiving TNF blockers, including Cimzia(R). Infections have been reported in patients receiving Cimzia(R) alone or in conjunction with immunosuppressive agents. Do not initiate treatment with Cimzia(R) in patients with active infections, including chronic or localized infections. Patients who develop a new infection while undergoing treatment with Cimzia(R) should be monitored closely. Discontinue administration of Cimzia(R) if a patient develops a serious infection. Exercise caution when considering the use of Cimzia(R) in patients with a history of recurrent infection, concomitant immunosuppressive therapy, or underlying conditions that may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic.
Use of TNF blockers, including Cimzia(R), 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(R) therapy. Exercise caution in prescribing Cimzia(R) for patients identified as carriers of HBV. Patients who are carriers of HBV and require treatment with Cimzia(R) should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, discontinue Cimzia(R) and initiate effective anti-viral therapy with appropriate supportive treatment.
During controlled and open-labeled portions of Cimzia(R) studies of Crohn's disease and other investigational uses, malignancies were observed at a rate (95% confidence interval) of 0.6 (0.4, 0.8) per 100 patient-years among 4,650 Cimzia(R)-treated patients verses a rate of 0.6 (0.2, 1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of the control group and limited duration of the controlled portions of the studies preclude the ability to draw firm conclusions. In studies of Cimzia(R) for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 Cimzia(R)-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. The potential role of TNF blocker therapy in the development of malignancies is not known.
Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following Cimzia(R) administration. If such reactions occur, discontinue further administration of Cimzia(R) and institute appropriate therapy.
Use of TNF blockers, including Cimzia(R), has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with Cimzia(R); the causal relationship to Cimzia(R) remains unclear. Exercise caution in considering the use of Cimzia(R) in patients with these disorders.
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(R). The causal relationship of these events to Cimzia(R) remains unclear. 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(R). Consider discontinuation of Cimzia(R) therapy in patients with confirmed significant hematologic abnormalities.
Serious infections were seen in clinical studies with concurrent use of anakinra (an interleukin-1 antagonist) and another TNF blocker, with no added benefit. Therefore, the combination of Cimzia(R) and anakinra is not recommended.
Interference with certain coagulation assays has been detected in patients treated with Cimzia(R). There is no evidence that Cimzia(R) therapy has an effect on in vivo coagulation.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cimzia(R) has not been formally studied in patients with CHF. Exercise caution when using Cimzia(R) in patients who have heart failure and monitor them carefully.
Treatment with Cimzia(R) 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.
Do not administer live vaccines or attenuated vaccines concurrently with Cimzia(R).
In controlled Crohn's clinical trials, the most common adverse events that occurred in more than or equal to 5% of Cimzia(R) patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% Cimzia(R), 13% placebo), urinary tract infection (7% Cimzia(R), 6% placebo), and arthralgia (6% Cimzia(R), 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for Cimzia(R) and 7% for placebo.
Cimzia(R) should be administered by a healthcare professional.
UCB, Brussels, Belgium (http://www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing around 12,000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB S.A. is listed on the Euronext Brussels (Euronext: UCB). Schwarz Pharma is a member of UCB-Group.
UCB Forward-Looking Statement
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.
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