Crucell Rabies Monoclonal Antibody Combination: Positive Results
Philippines Phase II Study Presente
(Thomson Reuters ONE) - Leiden, The Netherlands (October 20, 2009) - Dutch biopharma companyCrucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) todayannounced that detailed results of the Phase II Philippines study ofits rabies monoclonal antibody combination (CL 184) were presented atthe XX Rabies in the Americas (RITA) Conference in Quebec, Canada.The presentation was given by Dr Beatriz P. Quiambao (MD), ChiefClinical Research Division and Head, Rabies Research Group, ResearchInstitute for Tropical Medicine, Muntinlupa, Philippines and isavailable on Crucell's website www.crucell.com.In June 2009, Crucell announced the results of the Phase IIPhilippines study in healthy adolescents and children, which showedthat the antibody combination was safe and well tolerated.Neutralizing activity levels in subjects given the antibody productwere similar to those in subjects given human rabies immunoglobulin(HRIG), the current standard for inducing immediate, passiveimmunity. All study participants reached adequate immunity levels.This study in a paediatric population, performed at the ResearchInstitute for Tropical Medicine under the leadership of Dr Quiambao,further broadens the potential patient population for Crucell'srabies monoclonal antibody combination."We are very pleased with the outcome of the Philippines Phase IIstudy as our children are at high risk of getting rabies. Theprogress with this next generation rabies treatment brings us closerto the moment when all-in-need will get adequate treatment againstrabies." said Dr Quiambao."We continue to push this program forward in order to bring a highquality rabies treatment to the market as soon as possible. Plans tostart the third phase II clinical study are progressing well afterrecent approval received from the Drug Controller General of India."said Ronald Brus, CEO Crucell. "The market for Crucell's rabiesmonoclonal antibody combination is estimated to be significant withpeak sales expected to exceed $300 million."This third phase II study will be carried out at Lotus Laboratoriesin Bangalore, India and is planned to start within the next sixmonths. The rationale for this study is to collect safety andneutralizing activity data of the CL184 antibody in combination withthe vaccine in a simulated rabies post-exposure prophylaxis settingto be used in Phase III.Crucell's monoclonal antibody combination against rabies is beingdeveloped in close collaboration with Sanofi Pasteur using Crucell'sPER.C6® manufacturing technology. This antibody combination isdesigned to be used in combination with a rabies vaccine forpost-exposure prophylaxis against this fatal disease.In 2007 promising Phase I data showed no serious adverse effects anddemonstrated the expected rabies neutralizing activity uponadministration. Positive results of the Phase II US study werepresented to rabies experts at the 19th annual RITA meeting inAtlanta on October 1, 2008.About rabiesRabies is a viral disease of mammals most often transmitted throughthe bite of a rabid animal. The virus infects the central nervoussystem, causing encephalitis (inflammation of the brain) andultimately death if medical intervention is not sought promptly afterexposure. There is no proven treatment for rabies once symptoms ofthis fatal disease have appeared. Rabies is prevented bypost-exposure prophylaxis (PEP) with the combined administration of arabies vaccine and rabies immunoglobulin (RIG). Rabies is prevalentin Europe, Asia, Africa, North America and South America. Every yearapproximately 10 million people are vaccinated against the diseaseworldwide. An estimated 55,000 people die from rabies each year,mainly in Asia.About Crucell's rabies monoclonal antibody programCrucell's rabies monoclonal antibody product is a combination of twohuman monoclonal antibodies, generated using Crucell's MAbstract®technology and produced using Crucell's PER.C6® technology. Crucell'srabies monoclonal antibody combination offers the potential toreplace the traditional serum-derived products that are currentlyused for rabies post-exposure prophylaxis. Phase I clinical trialsdata conducted in the United States and India supported furtherclinical development. The program has been granted a Fast Trackdesignation by the US Food and Drug Administration's (FDA) Departmentof Health and Human Services in February 2008. The Fast Track programfacilitates the development and expedites the review of new drugsthat are intended to treat serious or life-threatening diseases andthat demonstrate the potential to address unmet medical needs.In December 2007, Crucell and Sanofi Pasteur signed an exclusivecollaboration and commercialization agreement for Crucell's rabiesmonoclonal antibodies, next-generation rabies biologicals, to be usedwith rabies vaccine for post-exposure prophylaxis against this fataldisease. Under the terms of the agreement, Crucell will continue toperform the development activities. Crucell will be responsible forthe manufacturing of the final product and will retain exclusivedistribution rights in Europe, co-exclusive distribution rights inChina and the rights to sell to supranational organizations such asUNICEF. Crucell received an initial payment of ?10 million followingthe execution of the agreement and will be eligible for milestonepayments of up to ?66.5 million.About PER.C6® technologyCrucell's PER.C6® technology is a cell line developed for thelarge-scale manufacture of biopharmaceutical products such asrecombinant proteins including monoclonal antibodies. The strengthsof the PER.C6® technology lie in its safety profile, scalability andproductivity under serum-free culture conditions.About MAbstract® technologyCrucell's proprietary MAbstract® technology can be used to discoverdrug targets, such as cancer markers or proteins from infectiousagents including bacteria and viruses, and identify human antibodiesagainst those drug targets.About CrucellCrucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is aglobal biopharmaceutical company focused on research development,production and marketing of vaccines, proteins and antibodies thatprevent and/or treat infectious diseases. Its vaccines are sold inpublic and private markets worldwide. Crucell's core portfolioincludes a vaccine against hepatitis B, a fully-liquid vaccineagainst five important childhood diseases and a virosome-adjuvantedvaccine against influenza. Crucell also markets travel vaccines, suchas the only oral anti-typhoid vaccine, an oral cholera vaccine andthe only aluminum-free hepatitis A vaccine on the market. The Companyhas a broad development pipeline, with several product candidatesbased on its unique PER.C6® production technology. The Companylicenses its PER.C6® technology and other technologies to thebiopharmaceutical industry. Important partners and licensees includeDSM Biologics, Sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck &Co. Crucell is headquartered in Leiden, the Netherlands, withsubsidiaries in Switzerland, Spain, Italy, Sweden, Korea, the UK andthe U.S. The Company employs over 1000 people. For more information,please visit www.crucell.com.Forward-looking statementsThis press release contains forward-looking statements that involveinherent risks and uncertainties. We have identified certainimportant factors that may cause actual results to differ materiallyfrom those contained in such forward-looking statements. Forinformation relating to these factors please refer to our Form 20-F,as filed with the U.S. Securities and Exchange Commission on April22, 2009, in the section entitled 'Risk Factors'. The Companyprepares its financial statements under International FinancialReporting Standards (IFRS).For further information please contact:Crucell N.V.Oya YavuzVice PresidentCorporate Communications & Investor RelationsTel. +31-(0)71-519 7064ir(at)crucell.comwww.crucell.comhttp://hugin.info/132631/R/1348634/324650.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 20.10.2009 - 15:01 Uhr
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Philippines Phase II Study Presente"
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