Annual Report 2002 - BIRD Foundation

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Life SciencesDevelopment of a Pharmaceutical Composition Containing Recombinant Factor VIII and LiposomesThe CompaniesOMRI Laboratories Ltd. — Bayer Corporation, Biological ProductsThe ProjectOMRI Laboratories Ltd. is a biopharmaceutical companylocated in the Weizmann Science Park, Nes-Ziona, Israel.The company focuses on the development of liposomes asa delivery vehicle for Factor VIII (FVIII) and other short half-lifeproteins. OMRI developed a formulation of FVIII and liposomesthat was evaluated pre-clinically in a hemophilic mousemodel. Results indicated an extension of half-life and enhancedstability of recombinant FVIII (rFVIII), as well as an increasein efficacy when FVIII is administrated in a liposome formulation.Further animal studies showed that the formulation is nontoxic.Bayer Biological Products is devoted to the discovery,manufacturing and marketing of plasma – derived therapiesand their recombinant (genetically engineered) and/or genetherapy replacements. Biological Products is a businessunit within Bayer's global Pharmaceutical Business Group,which is a part of Bayer Worldwide Group, a $32 billion chemicaland pharmaceutical company based in Leverkusen, Germany.The market for Factor VIII, a lifesaving drug for treatment ofhemophilia A patients, is rapidly growing from $2.5 billion/yearto $5 billion/year. Annual treatment costs of severe hemophilia(typically three injections/week) are very high, exceeding$150,000 per patient. This is due to the enormous cost ofmanufacturing of this very complex protein (the price of rFVIIIis about $5 million/gram).Advances in the treatment of hemophilia have been focusedon reducing safety risks (HIV, hepatitis, etc.), but there hasbeen no success in reducing dosage frequency.This project aims to develop a pharmaceutical compoundcontaining recombinant factor VIII and liposomes for thetreatment of hemophilia A patients in a formulation that willenable weekly injections instead of the current three timesper week. The commercial vial of freeze-dried FVIII isreconstituted in a mixture of proprietary liposomes and injected,as is currently done with FVIII.The project is now in a clinical trial with severe hemophilia Apatients. To date, four patients have received the newformulation; the drug has been well tolerated, and preventionof bleeding for over one week was observed in patients whotypically bleed every two to four days.10
“Having worked with Federal agencies such as the NIH, NSFand others, our experience with the BIRD Foundation hasbeen very gratifying. Responsiveness, flexibility and a highdegree of good will and professionalism characterized ourinteraction and contributed greatly to the project's successto date.”Dr. Moshe BaruHead, Research and DevelopmentOMRI LaboratoriesDevelopment of liposomes as a deliveryvehicle for factor VIII for the treatment ofhemophilia A patientsDr. David Naveh Chief Technical Officer,Bayer Cooperation, Biological ProductsExtension of half-life and stability,twice as long or moreNon-toxicIncrease in efficacyDr. Moshe BaruFewer injections will be neededNon-invasive therapeutic deviceIncreased qualityof the patient's lifeLonger protection against bleedingLower costFactor VIII isa blood-clotting factor11
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Annual Report 2002 - BIRD Foundation

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