UCB and AstraZeneca form alliance for the commercialization of Cimzia® in Brazil
Brussels (Belgium) - UCB and AstraZeneca announced today that they have entered into a partnership to register and commercialize UCB’s PEGylated anti-TNF alpha drug Cimzia® (certolizumab pegol) in Brazil. The drug is to be registered for the treatment of rheumatoid arthritis and Crohn’s disease.
Under the agreement, AstraZeneca will register Cimzia® and upon approval will be the exclusive distributor of Cimzia® in Brazil. In partnership with UCB, AstraZeneca will have the right to distribute future new line extensions related to Cimzia®. UCB retains the right to co-promote Cimzia® as well as future line extensions in Brazil. This partnership with AstraZeneca will help UCB commercialize its rich pipeline of products and foster the growth of UCB’s affiliate in Brazil.
“This is an important strategic partnership for us, and supports our combined focus on meeting patient needs and developing innovative medicines,” said Mark McDade, COO of UCB. “This relationship will ensure that as many Brazilian patients as possible get access to our innovative medicine Cimzia®.”
“This partnership with UCB will leverage AstraZeneca’s expertise in regulatory affairs, sales and marketing to help bring the benefits of Cimzia® to patients in Brazil,” said Rubens Pedrosa, president and representative director of AstraZeneca Brazil. “AstraZeneca has been one of the fastest growing pharma companies in the country and Cimzia® will complement our current portfolio of innovative medicines and support our continued growth in this important market.”
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® was approved in Switzerland for induction of a clinical response and for the maintenance of a clinical response and a remission in patients with active Crohn’s disease who have not responded adequately to conventional treatment in September 2007. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.
Important safety information
The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 15.5% of patients on Cimzia and 7.6% of patients on placebo, and General disorders and administration site conditions, reported in 10.0% of patients on Cimzia and 9.7% of patients on placebo. The most serious adverse reactions were serious infections (including tuberculosis and histoplasmosis), malignancies (including lymphoma) and heart failure. A pooled analysis of the safety data show there was a low incidence of injection site pain (1.5 percent) and low level of discontinuations due to adverse events.
Cimzia® is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections and in patients with moderate to severe heart failure. Before initiation of Cimzia®, evaluate patients for both active or inactive (latent) tuberculosis infection. Monitor patients for the development of signs and symptoms of infection during and after treatment with Cimzia®. If an infection develops, monitor carefully, and stop Cimzia® if infection becomes serious.
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, of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, in the formation of autoantibodies and uncommonly in the development of a lupus-like syndrome or of severe hypersensitivity reactions following Cimzia administration. If a patient develops any of these adverse reactions, Cimzia® should be discontinued and appropriate therapy instituted.
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 haematological abnormalities.
The use of Cimzia® in combination with biological DMARDS such as anakinra, abatacept and rituximab 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 or attenuated vaccines.
Please see full prescribing information before prescribing.
UCB, Brussels, Belgium (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 approximately 10 000 people in over 40 countries, UCB produced revenue of 3.6 billion euro in 2008. 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. 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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