MorphoSys Antibody Reaches Major Milestone in Collaboration with Roche
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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 that its
partner Roche (SIX: RO, ROG; OTCQX: RHHBY) has expanded the ongoing SCarlet RoAD
Phase 2 clinical trial of gantenerumab for prodromal (early) Alzheimer's disease
to a potentially pivotal study. The trial size will be increased from 360 to
770 participants, and a favorable outcome to the trial could be used by Roche to
support a marketing application for gantenerumab. The expansion of the study
triggered a clinical milestone payment to MorphoSys, the details of which were
not disclosed. MorphoSys stands to receive further developmental milestones as
well as royalties on product sales.
"This is a major step forward for a HuCAL antibody program that has genuine
blockbuster potential", commented Dr. Marlies Sproll, Chief Scientific Officer
of MorphoSys AG. "Gantenerumab is the first investigational antibody development
program for Alzheimer's disease to be clinically tested in a setting for which
there is great hope, namely the treatment of early-stage, pre-dementia subjects.
A potential path to market for this program has become much clearer with this
transition to a pivotal trial".
"We believe the greater opportunity to make a difference in patients' lives is
in early diagnosis and intervention," said Luca Santarelli, Head of Neuroscience
at Roche. "Our attempt is to utilize a biomarker-driven approach, leveraging
both our pharmaceutical and diagnostics divisions to develop a companion
diagnostic for gantenerumab to select patients at the prodromal stage, before
significant damage to the brain has occurred."
Gantenerumab is an optimized, fully human antibody that was developed on behalf
of Roche by MorphoSys scientists using the Company's proprietary HuCAL
technology. Gantenerumab is unique amongst antibodies in development in that it
binds to both the N-terminus and mid-section of the 42 amino acid amyloid-β
peptide. 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 found
to bring about rapid, dose-dependent clearance of plaque from the brains of mild
to moderate Alzheimer's disease patients. The ongoing clinical trial is designed
to evaluate its effect on cognition and functioning as well as its safety and
pharmacokinetics in patients with prodromal, or early-stage, Alzheimer's
disease. In this phase of the disease, which can be characterized by measuring
certain biomarkers, patients have only mild cognitive impairment and have not
yet been diagnosed with Alzheimer's disease. According to recent research,
amyloid plaque may accumulate even at this early stage in the brains of
sufferers, and may lead to full-blown disease.
MorphoSys's clinical pipeline now comprises one program in phase 3 development,
seven in phase 2 and twelve in phase 1. Of these, four are proprietary, as yet
un-partnered programs, namely MOR103, which is in a phase 1b/2a trial for
rheumatoid arthritis and a phase 1b trial in multiple sclerosis, MOR208, which
is in a phase 1 trial for chronic lymphocytic leukemia and MOR202, which is in a
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
Neurology, 68(10); http://archneur.ama-
assn.org/cgi/content/full/archneurol.2011.1538
About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in
the pharmaceutical industry. By successfully applying this and other patented
technologies, MorphoSys has become a leader in the field of therapeutic
antibodies, one of the fastest-growing drug classes in human healthcare. The
Company's AbD Serotec unit uses HuCAL and other antibody technologies to
generate superior monoclonal antibodies for research and diagnostic
applications.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic
pipeline of more than 70 human antibody drug candidates for the treatment of
cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With
its ongoing commitment to new antibody technology and drug development,
MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is
listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates
about 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 statements concerning the
MorphoSys group of companies. The forward-looking statements contained herein
represent the judgment of MorphoSys as of the date of this release and involve
risks and uncertainties. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ from those anticipated.
MorphoSys does not intend to update any of these forward-looking statements as
far as the wording of the relevant press release is concerned.
For more information, please contact:
MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-122
Mario Brkulj
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454
Jessica Kulpi
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/1617342/516085.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: MorphoSys AG via Thomson Reuters ONE
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