MARTINSRIED, GERMANY and MUNICH, GERMANY--(Marketwire - June 06, 2012) -
MorphoSys AG /
MorphoSys Antibody Reaches Major Milestone in Collaboration with Roche
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Gantenerumab Clinical Trial Expanded to Pivotal Phase 2/3 Study
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today
partner Roche (SIX: RO, ROG; OTCQX: RHHBY) has expanded the ongoing SCarlet
Phase 2 clinical trial of gantenerumab for prodromal (early) Alzheimer's
to a potentially pivotal study. The trial size will be increased from
770 participants, and a favorable outcome to the trial could be used by
support a marketing application for gantenerumab. The expansion of the
triggered a clinical milestone payment to MorphoSys, the details of which
not disclosed. MorphoSys stands to receive further developmental
well as royalties on product sales.
"This is a major step forward for a HuCAL antibody program that has
blockbuster potential", commented Dr. Marlies Sproll, Chief Scientific
of MorphoSys AG. "Gantenerumab is the first investigational antibody
program for Alzheimer's disease to be clinically tested in a setting for
there is great hope, namely the treatment of early-stage, pre-dementia
A potential path to market for this program has become much clearer with
transition to a pivotal trial".
"We believe the greater opportunity to make a difference in patients'
in early diagnosis and intervention," said Luca Santarelli, Head of
at Roche. "Our attempt is to utilize a biomarker-driven approach,
both our pharmaceutical and diagnostics divisions to develop a
diagnostic for gantenerumab to select patients at the prodromal stage,
significant damage to the brain has occurred."
Gantenerumab is an optimized, fully human antibody that was developed on
of Roche by MorphoSys scientists using the Company's proprietary
technology. Gantenerumab is unique amongst antibodies in development in
binds to both the N-terminus and mid-section of the 42 amino acid
amyloid-βpeptide. It has been shown to break down amyloid plaque
both in vitro and in
vivo. In Phase 1 clinical trials conducted by Roche(1), the antibody was
to bring about rapid, dose-dependent clearance of plaque from the brains of
to moderate Alzheimer's disease patients. The ongoing clinical trial is
to evaluate its effect on cognition and functioning as well as its
pharmacokinetics in patients with prodromal, or early-stage,
disease. In this phase of the disease, which can be characterized by
certain biomarkers, patients have only mild cognitive impairment and
yet been diagnosed with Alzheimer's disease. According to recent
amyloid plaque may accumulate even at this early stage in the
sufferers, and may lead to full-blown disease.
MorphoSys's clinical pipeline now comprises one program in phase 3
seven in phase 2 and twelve in phase 1. Of these, four are proprietary,
un-partnered programs, namely MOR103, which is in a phase 1b/2a
rheumatoid arthritis and a phase 1b trial in multiple sclerosis, MOR208,
is in a phase 1 trial for chronic lymphocytic leukemia and MOR202, which is
phase 1/2a trial for multiple myeloma.
(1) Reference: Ostrowitzki, S. et al (2011) Mechanism of Amyloid Removal in
Patients With Alzheimer Disease Treated With Gantenerumab. Archives of
MorphoSys developed HuCAL, the most successful antibody library technology
the pharmaceutical industry. By successfully applying this and other
technologies, MorphoSys has become a leader in the field of therapeutic
antibodies, one of the fastest-growing drug classes in human healthcare.
Company's AbD Serotec unit uses HuCAL and other antibody technologies to
generate superior monoclonal antibodies for research and diagnostic
Together with its pharmaceutical partners, MorphoSys has built a
pipeline of more than 70 human antibody drug candidates for the treatment
cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few.
its ongoing commitment to new antibody technology and drug development,
MorphoSys is focused on making the healthcare products of tomorrow.
listed on the Frankfurt Stock Exchange under the symbol MOR. For regular
about MorphoSys, visit http://www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, Ylanthia®,
RapMAT® and arYla® are registered trademarks of MorphoSys.
This communication contains certain forward-looking statements
MorphoSys group of companies. The forward-looking statements contained
represent the judgment of MorphoSys as of the date of this release and
risks and uncertainties. Should actual conditions differ from the
assumptions, actual results and actions may differ from those
MorphoSys does not intend to update any of these forward-looking
far as the wording of the relevant press release is concerned.
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Source: MorphoSys AG via Thomson Reuters ONE