MVI and Crucell Announce Collaboration new Malaria Vaccine Approach
(Thomson Reuters ONE) - Partners seek to protect against deadliest malaria parasite usingvirus-based transport method to deliver malaria antigenLeiden, The Netherlands (July 29, 2009) - The U.S.-based PATH MalariaVaccine Initiative (MVI), the United States Agency for InternationalDevelopment (USAID) Malaria Vaccine Development Program (MVDP) andDutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL;Swiss Exchange: CRX) today announced a collaboration to acceleratedevelopment of a promising type of malaria vaccine. Through fundingfrom the USAID MVDP, the partners will conduct studies to determinethe effectiveness of Crucell's novel prime-boost vaccine approachagainst the malaria parasite, Plasmodium falciparum. This approachuses Crucell's proprietary recombinant adenoviruses (a type of virusassociated with the common cold and other mild respiratoryinfections) to deliver a malaria antigen to the immune system.Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell commented:"This agreement is a strong validation of Crucell's malaria vaccine.We are excited to have the MVI as our partner and the support ofUSAID. The fact that MVI is backing our program testifies to theimportance of our efforts to further progress the development ofCrucell's malaria vaccine."For MVI, this partnership adds to its existing portfolio a vaccineapproach with the potential to elicit a more comprehensive immuneresponse than has been seen to date from the circumsporozoite protein(CSP), the only antigen that has proven to be protective incontrolled challenge studies and field studies. Using Crucell'sAdVac® technology with two different adenovirus vectors - Ad35 andAd26 - as delivery mechanisms, this approach seeks to elicit aprotective immune response obtained from delivering the CSP. Thesafety, immunogenicity and efficacy data from these studies willadvance the research forward in the further development of a safe andhighly effective malaria vaccine.Dr. Christian Loucq, Director at MVI said: "Adenoviruses are one ofthe most potent vaccine delivery systems tested to date in humans. Weare excited about the potential of Crucell's adenovirus-based programand the novel Ad35/Ad26 approach. The prime-boost regimen may be acritical next step in malaria vaccine development and, if successfulwould move us toward our goal of having an 80% efficacious vaccine inuse by 2025."Crucell is developing a recombinant malaria vaccine, Ad35-CS, basedon the company's AdVac® technology and PER.C6® manufacturingplatform. The vaccine candidate is made by inserting the gene for theCSP from the P. falciparum malaria parasite into adenoviral vectors,which act as a 'vehicle' for vaccination delivery. This prime vaccinecandidate is currently being tested in a phase I study in partnershipwith the National Institute of Allergy and Infectious Diseases(NIAID). This new collaboration will make it possible to clinicallydevelop the Ad26 boost component of the vaccine and allow Crucell tofurther strengthen and expedite its malaria development program.Carter Diggs at the USAID MVDP said, "We are pleased to support thisadenovirus approach, which could play a vital role in malaria vaccinedevelopment."About AdVac® technologyAdVac® technology is a vaccine technology developed by Crucell and isconsidered to play an important role in the fight against emergingand re-emerging infectious diseases, and in biodefense. Thetechnology supports the practice of inserting genetic material fromthe disease-causing virus or parasite into a 'vehicle' called avector, which then delivers the immunogenic material directly to theimmune system. Most vectors are based on an adenovirus, such as thevirus that causes the common cold.The AdVac® technology is specifically designed to manage the problemof pre-existing immunity in humans against the most commonly usedrecombinant vaccine vector, adenovirus serotype 5 (Ad5), withoutcompromising large-scale production capabilities or the immunogenicproperties of Ad5. AdVac® technology is based on adenoviruses that donot regularly occur in the human population, such as Ad26 and Ad35.In contrast to Ad26 and Ad35 antibodies, antibodies to Ad5 arewidespread among people of all ages and are known to lower the immuneresponse to Ad5-based vaccines, thereby impairing the efficacy ofthese vaccines. All vaccine candidates based on AdVac® are producedusing Crucell's PER.C6® production technology.About PER.C6® technologyCrucell's PER.C6® technology is a cell line developed for thelarge-scale manufacture of biopharmaceutical products includingvaccines. The production scale potential of the PER.C6® cell line hasbeen demonstrated in an unprecedented successful bioreactor run of20,000 liters. Compared to conventional production technologies, thestrengths of the PER.C6® technology lie in its excellent safetyprofile, scalability and productivity under serum-free cultureconditions. These characteristics, combined with its ability tosupport the growth of both human and animal viruses, make PER.C6®technology the biopharmaceutical production technology of choice forCrucell's current and potential pharmaceutical and biotechnologypartners.About MalariaMalaria is one of today's top three killers among communicablediseases. The disease currently represents one of the most prevalentinfections in tropical and subtropical areas causing severe illnessin approximately 250 million individuals worldwide and causing closeto 900,000 deaths every year. Most of these deaths occur amongchildren under the age of five and pregnant women in sub SaharanAfrica. Unfortunately, mortality associated with severe orcomplicated malaria still exceeds 10-30 percent. Malaria is caused bythe Plasmodium parasite and transmitted person-to-person through thebite of a female Anopheles mosquito. Although the overwhelmingmajority of illness and death associated with malaria occurs in thedeveloping world, this disease also affects travellers.About MVIThe PATH Malaria Vaccine Initiative is a focused vaccine developmentprogram created in 1999 through a grant from the Bill & Melinda GatesFoundation. MVI's mission is to accelerate the development ofpromising malaria vaccines and ensure their availability andaccessibility in the developing world. PATH is an international, nonprofit organization that creates sustainable, culturally relevantsolutions, enabling communities worldwide to break longstandingcycles of poor health. By collaborating with diverse public- andprivate-sector partners, PATH helps provide appropriate healthtechnologies and vital strategies that change the way people thinkand act.About the USAID MVDPThe MVDP is a unit of the Division of Infectious Diseases of theOffice of Health, Nutrition, and Infectious Diseases of the USAIDGlobal Health Bureau. The MVDP, which was initiated in 1965 inresponse to the end of the first malaria eradication era, has workedwith a variety of partners to contribute early research on theCircumsporozoite Protein and more recently, development of bloodstage vaccine approaches leading to many of the investigationalmalaria vaccines fielded in recent years. Its mission is congruentwith that of MVI: to develop and introduce malaria vaccines toprotect vulnerable populations in the developing world. For furtherinformation:http://www.usaid.gov/our_work/global_health/id/malaria/techareas/vaccine.htmlAbout 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 and the U.S.The Company employs over 1000 people. For more information, pleasevisit www.crucell.com.Forward-looking statementsThis press release contains forward-looking statements that involveinherent risks and uncertainties. Crucell has 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. +3171 519 7064ir(at)crucell.comwww.crucell.comhttp://hugin.info/132631/R/1331245/314904.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 29.07.2009 - 07:45 Uhr
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