MARTINSRIED, GERMANY and MUNICH, GERMANY--(Marketwire -06/06/12)-
MorphoSys AG /MorphoSys Antibody Reaches Major Milestone in Collaboration with Roche. Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.
Gantenerumab Clinical Trial Expanded to Pivotal Phase 2/3 Study
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced todaythat itspartner Roche (SIX: RO, ROG; OTCQX: RHHBY) has expanded the ongoing SCarletRoADPhase 2 clinical trial of gantenerumab for prodromal (early) Alzheimer'sdiseaseto a potentially pivotal study. The trial size will be increased from360 to770 participants, and a favorable outcome to the trial could be used byRoche tosupport a marketing application for gantenerumab. The expansion of thestudytriggered a clinical milestone payment to MorphoSys, the details of whichwerenot disclosed. MorphoSys stands to receive further developmentalmilestones aswell as royalties on product sales.
"This is a major step forward for a HuCAL antibody program that hasgenuineblockbuster potential", commented Dr. Marlies Sproll, Chief ScientificOfficerof MorphoSys AG. "Gantenerumab is the first investigational antibodydevelopmentprogram for Alzheimer's disease to be clinically tested in a setting forwhichthere is great hope, namely the treatment of early-stage, pre-dementiasubjects.A potential path to market for this program has become much clearer withthistransition to a pivotal trial".
"We believe the greater opportunity to make a difference in patients'lives isin early diagnosis and intervention," said Luca Santarelli, Head ofNeuroscienceat Roche. "Our attempt is to utilize a biomarker-driven approach,leveragingboth our pharmaceutical and diagnostics divisions to develop acompaniondiagnostic for gantenerumab to select patients at the prodromal stage,beforesignificant damage to the brain has occurred."
Gantenerumab is an optimized, fully human antibody that was developed onbehalfof Roche by MorphoSys scientists using the Company's proprietaryHuCALtechnology. Gantenerumab is unique amongst antibodies in development inthat itbinds to both the N-terminus and mid-section of the 42 amino acidamyloid-βpeptide. It has been shown to break down amyloid plaqueboth in vitro and invivo. In Phase 1 clinical trials conducted by Roche(1), the antibody wasfoundto bring about rapid, dose-dependent clearance of plaque from the brains ofmildto moderate Alzheimer's disease patients. The ongoing clinical trial isdesignedto evaluate its effect on cognition and functioning as well as itssafety andpharmacokinetics in patients with prodromal, or early-stage,Alzheimer'sdisease. In this phase of the disease, which can be characterized bymeasuringcertain biomarkers, patients have only mild cognitive impairment andhave notyet been diagnosed with Alzheimer's disease. According to recentresearch,amyloid plaque may accumulate even at this early stage in thebrains ofsufferers, and may lead to full-blown disease.
MorphoSys's clinical pipeline now comprises one program in phase 3development,seven in phase 2 and twelve in phase 1. Of these, four are proprietary,as yetun-partnered programs, namely MOR103, which is in a phase 1b/2atrial forrheumatoid arthritis and a phase 1b trial in multiple sclerosis, MOR208,whichis in a phase 1 trial for chronic lymphocytic leukemia and MOR202, which isin aphase 1/2a trial for multiple myeloma.
(1) Reference: Ostrowitzki, S. et al (2011) Mechanism of Amyloid Removal inPatients With Alzheimer Disease Treated With Gantenerumab. Archives ofNeurology, 68(10);http://archneur.ama-assn.org/cgi/content/full/archneurol.2011.1538
MorphoSys developed HuCAL, the most successful antibody library technologyinthe pharmaceutical industry. By successfully applying this and otherpatentedtechnologies, MorphoSys has become a leader in the field of therapeuticantibodies, one of the fastest-growing drug classes in human healthcare.TheCompany's AbD Serotec unit uses HuCAL and other antibody technologies togenerate superior monoclonal antibodies for research and diagnosticapplications.Together with its pharmaceutical partners, MorphoSys has built atherapeuticpipeline of more than 70 human antibody drug candidates for the treatmentofcancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few.Withits ongoing commitment to new antibody technology and drug development,MorphoSys is focused on making the healthcare products of tomorrow.MorphoSys islisted on the Frankfurt Stock Exchange under the symbol MOR. For regularupdatesabout MorphoSys, visit http://www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, Ylanthia®,CysDisplay®,RapMAT® and arYla® are registered trademarks of MorphoSys.
This communication contains certain forward-looking statementsconcerning theMorphoSys group of companies. The forward-looking statements containedhereinrepresent the judgment of MorphoSys as of the date of this release andinvolverisks and uncertainties. Should actual conditions differ from theCompany'sassumptions, actual results and actions may differ from thoseanticipated.MorphoSys does not intend to update any of these forward-lookingstatements asfar as the wording of the relevant press release is concerned.
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Source: MorphoSys AG via Thomson Reuters ONE[HUG#1617342]
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