12.06.2018
MorphoSys AG DE0006632003
DGAP-News: New Phase 3 Clinical Trials by MorphoSys's Partner with Gantenerumab in Early Alzheimer's Disease now Underway
DGAP-News: MorphoSys AG / Key word(s): Study
New Phase 3 Clinical Trials by MorphoSys's Partner with Gantenerumab in
Early Alzheimer's Disease now Underway (news with additional features)
12.06.2018 / 22:01
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany, June 12, 2018
New Phase 3 Clinical Trials by MorphoSys's Partner with Gantenerumab in
Early Alzheimer's Disease now Underway
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; Nasdaq: MOR)
announced today that the first patient has been enrolled in a new phase 3
trial of gantenerumab in patients with early Alzheimer's disease.
Gantenerumab is a monoclonal antibody directed against amyloid-beta
generated by MorphoSys using its proprietary HuCAL antibody technology.
Roche is fully responsible for the clinical development of gantenerumab.
MorphoSys is entitled to receive potential success-based regulatory
milestone payments related to gantenerumab and royalties on net sales.
Expected to enroll approximately 1,520 patients in up to 350 study centers
in 31 countries worldwide, the pivotal program consists of the two phase 3
studies named GRADUATE-1 and GRADUATE-2. The two multicenter, randomized,
double-blind, placebo-controlled trials will enroll up to 760 patients each,
to assess the efficacy and safety of gantenerumab in patients with early
(prodromal to mild) Alzheimer's disease. All participants need to show
evidence of beta-amyloid pathology. Patients will receive placebo or
gantenerumab as subcutaneous injection with optimized titration up to the
target dose. The primary endpoint for both trials is the assessment of signs
and symptoms of dementia, measured as the clinical dementia rating-sum of
boxes (CDR-SOB) score, determined as the change of the status from baseline
to week 104.
"This is great news for MorphoSys. We are delighted by the commitment to
gantenerumab as a potential new therapy for Alzheimer's disease, and the
sustained clinical development of this antibody in this area of immense
unmet medical need. We look forward to seeing the effect of the optimized
dosing regimen in the new phase 3 trials run by our partner Roche in early
Alzheimer's patients", commented Dr. Markus Enzelberger, Chief Scientific
Officer of MorphoSys AG.
More information about gantenerumab clinical studies is available on
clinicaltrials.gov.
About MorphoSys
MorphoSys is a late-stage, biopharmaceutical company devoted to the
development of innovative and differentiated therapies for patients
suffering from serious diseases. Based on its technological leadership in
generating antibodies, MorphoSys, together with its partners, has developed
and contributed to the development of more than 100 product candidates, of
which 28 are currently in clinical development. This broad pipeline spans
MorphoSys's two business segments: Proprietary Development, in which
MorphoSys invests in product candidates for its own account, and Partnered
Discovery, in which product candidates are developed exclusively for a
variety of Pharma and Biotech partners. In 2017, Tremfya(R) (guselkumab),
marketed by Janssen, became the first therapeutic antibody based on
MorphoSys's proprietary technology to receive marketing approval for the
treatment of moderate to severe plaque psoriasis in the United States, the
European Union and Canada. MorphoSys is listed on the Frankfurt Stock
Exchange and on the U.S. stock exchange Nasdaq, under the symbol MOR. For
regular updates about MorphoSys, visit http://www.morphosys.com.
HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R),
arYla(R),
Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R)
and LanthioPep(R) are registered trademarks of the MorphoSys Group.
Tremfya(R)
is a trademark of Janssen Biotech, Inc.
MorphoSys forward looking statements
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the commencement of the
GRADUATE-trials in connection with gantenerumab and expectations regarding
the development of gantenerumab in Alzheimer's disease, including the
intended targeting of Amyloid-beta. The forward-looking statements contained
herein represent the judgment of MorphoSys as of the date of this release
and involve known and unknown risks and uncertainties, which might cause the
actual results, financial condition and liquidity, performance or
achievements of MorphoSys, or industry results, to be materially different
from any historic or future results, financial conditions and liquidity,
performance or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance, financial
condition and liquidity, and the development of the industry in which it
operates are consistent with such forward-looking statements, they may not
be predictive of results or developments in future periods. Among the
factors that may result in differences are the inherent uncertainties
associated with competitive developments, clinical trial and product
development activities and regulatory approval requirements, MorphoSys'
reliance on collaborations with third parties and other risks indicated in
the risk factors included in MorphoSys's Registration Statement on Form F-1
and other filings with the US Securities and Exchange Commission. Given
these uncertainties, the reader is advised not to place any undue reliance
on such forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. MorphoSys expressly
disclaims any obligation to update any such forward-looking statements in
this document to reflect any change in its expectations with regard thereto
or any change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements, unless
specifically required by law or regulation.
For more information, please contact:
MorphoSys AG
Alexandra Goller
Associate Director Corporate Communications & IR
Jochen Orlowski
Associate Director Corporate Communications & IR
Dr. Claudia Gutjahr-Löser
Investor Relations Officer
Tel: +49 (0) 89 / 899 27-404
[email protected]
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Additional features:
Document: http://n.eqs.com/c/fncls.ssp?u=FDQWDIKKKN
Document title: Press Release
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12.06.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: [email protected]
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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