10.07.2018
MorphoSys AG DE0006632003
DGAP-News: MorphoSys Announces its Licensee Janssen has Initiated a Phase 2/3 Program (GALAXI) to Evaluate Tremfya(R) (Guselkumab) in Crohn's Disease
DGAP-News: MorphoSys AG / Key word(s): Study/Miscellaneous
MorphoSys Announces its Licensee Janssen has Initiated a Phase 2/3 Program
(GALAXI) to Evaluate Tremfya(R) (Guselkumab) in Crohn's Disease (news with
additional features)
10.07.2018 / 22:01
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany, July 10, 2018
MorphoSys Announces its Licensee Janssen has Initiated a Phase 2/3 Program
(GALAXI) to Evaluate Tremfya(R) (Guselkumab) in Crohn's Disease
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR)
announced today that its licensee Janssen Research & Development, LLC, part
of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), has
initiated a pivotal phase 2/3 clinical program to evaluate the efficacy and
safety of Tremfya(R) (guselkumab) in the treatment of patients with
moderately to severely active Crohn's disease. Expected to enroll
approximately 2,000 patients, the program, which is named GALAXI, consists
of three separate studies, a phase 2 study (GALAXI 1), followed by two phase
3 studies (GALAXI 2 and GALAXI 3).
Tremfya(R) is a fully human anti-IL-23 monoclonal antibody developed by
Janssen, and was generated utilizing MorphoSys's proprietary HuCAL antibody
technology.
In connection with the start of the GALAXI program, MorphoSys will receive
two milestone payments from Janssen. Financial details were not disclosed.
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: "We
are very pleased that our licensee Janssen has started a pivotal phase 2/3
development program in Crohn's disease, a severe illness where significant
unmet needs exist despite the availability of some effective therapies. If
successful, this could result in a further expansion of the therapeutic
range of Tremfya(R)."
Crohn's disease is a type of inflammatory bowel disease (IBD) affecting any
part of the gastrointestinal tract. In addition to the clinical development
in Crohn's disease, Tremfya(R) is currently being investigated in two phase
3 trials in psoriatic arthritis. Tremfya(R) has been approved in the U.S.,
Canada, the European Union, and several other countries for the treatment of
plaque psoriasis and in Japan for the treatment of both psoriasis and
psoriatic arthritis.
More information about Tremfya(R) (guselkumab) clinical studies is available
on clinicaltrials.gov.
About Crohn's disease
Crohn's disease is a chronic inflammatory bowel disease (IBD) characterized
by inflammation of the digestive, or gastrointestinal (GI) tract affecting
about 700,000 people in the U.S. Crohn's disease can affect any part of the
GI tract, from the mouth to the anus, but it is more commonly found at the
end of the small intestine. The disease can also affect eyes, the skin and
joints. Currently, there is no cure for Crohn's disease. Though the exact
cause of the disease is unknown, genes, the immune system and environmental
factors are all believed to play a role in the onset of the disease.
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 the
Company 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.
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, expectations regarding a pivotal clinical
development program of Tremfya(R) in Crohn's disease and milestone payments
received on the start of a clinical development program of Tremfya(R) in
Crohn's disease, the further clinical development of Tremfya(R) including
the treatment of psoriatic arthritis and the possible further expansion of
the therapeutic range of Tremfya(R). 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 MorphoSys' expectations regarding
a pivotal clinical development program of Tremfya(R) in Crohn's disease and
milestone payments received on the start of a clinical development program
of Tremfya(R) in Crohn's disease, the further clinical development of
Tremfya(R) including the treatment of psoriatic arthritis and the possible
further expansion of the therapeutic range of Tremfya(R) may be incorrect,
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 as 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-Loeser
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=OCBQJIYDJO
Document title: Media Release
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10.07.2018 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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