UCB and AstraZeneca form alliance for the commercialization of
Cimzia® in Brazil
(Thomson Reuters ONE) - Brussels (Belgium), 28th Sept, 2009 - 7:00 AM (CEST) - press release,regulated information - UCB and AstraZeneca announced today that theyhave entered into a partnership to register and commercialize UCB'sPEGylated anti-TNF alpha drug Cimzia® (certolizumab pegol) in Brazil.The drug is to be registered for the treatment of rheumatoidarthritis and Crohn's disease.Under the agreement, AstraZeneca will register Cimzia® and uponapproval will be the exclusive distributor of Cimzia® in Brazil. Inpartnership with UCB, AstraZeneca will have the right to distributefuture new line extensions related to Cimzia®. UCB retains the rightto co-promote Cimzia® as well as future line extensions in Brazil.This partnership with AstraZeneca will help UCB commercialize itsrich pipeline of products and foster the growth of UCB's affiliate inBrazil."This is an important strategic partnership for us, and supports ourcombined focus on meeting patient needs and developing innovativemedicines," said Mark McDade, COO of UCB. "This relationship willensure that as many Brazilian patients as possible get access to ourinnovative medicine Cimzia®.""This partnership with UCB will leverage AstraZeneca's expertise inregulatory affairs, sales and marketing to help bring the benefits ofCimzia® to patients in Brazil," said Rubens Pedrosa, president andrepresentative director of AstraZeneca Brazil. "AstraZeneca has beenone of the fastest growing pharma companies in the country andCimzia® will complement our current portfolio of innovative medicinesand support our continued growth in this important market."For further informationScott Fleming, Global Communications Manager - ImmunologyT +44.770.277.7378, scott.fleming(at)ucb.comNancy Nackaerts, External Communications, UCBM: +32.473.86.44.14, nancy.nackaerts(at)ucb.comRichard Simpson, Investor Relations, UCBT +32.2.559.9494, richard.simpson(at)ucb.comMichael Tuck-Sherman, Investor Relations, UCBT +32.2.559.9712, michael.tuck-sherman(at)ucb.comAbout CIMZIA®Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor).Cimzia® has a high affinity for human TNF-alpha, selectivelyneutralizing the pathophysiological effects of TNF-alpha. Over thepast decade, TNF-alpha has emerged as a major target of basicresearch and clinical investigation. This cytokine plays a key rolein mediating pathological inflammation, and excess TNF-alphaproduction has been directly implicated in a wide variety ofdiseases. The U.S. Food and Drug Administration (FDA) has approvedCimzia® for reducing signs and symptoms of Crohn's disease andmaintaining clinical response in adult patients with moderately toseverely active disease who have had an inadequate response toconventional therapy and for the treatment of adults with moderatelyto severely active rheumatoid arthritis. Cimzia® was approved inSwitzerland for induction of a clinical response and for themaintenance of a clinical response and a remission in patients withactive Crohn's disease who have not responded adequately toconventional treatment in September 2007. UCB is also developingCimzia® in other autoimmune disease indications. Cimzia® is aregistered trademark of UCB PHARMA S.A.Important safety informationThe most common adverse reactions belonged to the system organclasses Infections and infestations, reported in 15.5% of patients onCimzia and 7.6% of patients on placebo, and General disorders andadministration site conditions, reported in 10.0% of patients onCimzia and 9.7% of patients on placebo. The most serious adversereactions were serious infections (including tuberculosis andhistoplasmosis), malignancies (including lymphoma) and heart failure.A pooled analysis of the safety data show there was a low incidenceof injection site pain (1.5 percent) and low level ofdiscontinuations due to adverse events.Cimzia® is contraindicated in patients with active tuberculosis orother severe infections such as sepsis, abscesses and opportunisticinfections and in patients with moderate to severe heart failure.Before initiation of Cimzia®, evaluate patients for both active orinactive (latent) tuberculosis infection. Monitor patients for thedevelopment of signs and symptoms of infection during and aftertreatment 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 ofreactivation of hepatitis B virus (HBV) in patients who are chroniccarriers of this virus, of new onset or exacerbation of clinicalsymptoms and/or radiographic evidence of demyelinating disease, inthe formation of autoantibodies and uncommonly in the development ofa lupus-like syndrome or of severe hypersensitivity reactionsfollowing Cimzia administration. If a patient develops any of theseadverse reactions, Cimzia® should be discontinued and appropriatetherapy instituted.Adverse reactions of the hematologic system, including medicallysignificant cytopenia, have been infrequently reported with Cimzia®.Advise all patients to seek immediate medical attention if theydevelop signs and symptoms suggestive of blood dyscrasias orinfection (e.g., persistent fever, bruising, bleeding, pallor) whileon Cimzia®. Consider discontinuation of Cimzia® therapy in patientswith confirmed significant haematological abnormalities.The use of Cimzia® in combination with biological DMARDS such asanakinra, abatacept and rituximab is not recommended due to apotential increased risk of serious infections. As no data areavailable, Cimzia® should not be administered concurrently with livevaccines or attenuated vaccines.Please see full prescribing information before prescribing.About UCBUCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical companydedicated to the research, development and commercialization ofinnovative medicines with a focus on the fields of central nervoussystem and immunology disorders. Employing approximately 10 000people in over 40 countries, UCB produced revenue of 3.6 billion euroin 2008. UCB is listed on Euronext Brussels (symbol: UCB).Forward looking statementThis press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of its employees.For the pdf-version of this press release, please click on the linkbelow:http://hugin.info/133973/R/1343775/321976.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 28.09.2009 - 07:00 Uhr
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