26.04.2018
MorphoSys AG DE0006632003
DGAP-News: MorphoSys Announces Approval of Tremfya(R) (Guselkumab) in South Korea
DGAP-News: MorphoSys AG / Key word(s): Regulatory Approval
MorphoSys Announces Approval of Tremfya(R) (Guselkumab) in South Korea (news
with additional features)
26.04.2018 / 22:00
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany, April 26, 2018
MorphoSys Announces Approval of Tremfya(R) (Guselkumab) in South Korea
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY; Nasdaq:
MOR) announced today that an affiliate of its licensee, Janssen Korea Ltd.
(Janssen), reported that South Korea's Ministry of Food and Drug Safety has
approved Tremfya(R) (guselkumab) for the treatment of moderate to severe
adult plaque psoriasis requiring phototherapy or systemic therapies.
Tremfya(R) is a fully human anti-IL-23 monoclonal antibody developed by
Janssen Research & Development, LLC and was generated utilizing MorphoSys's
proprietary HuCAL antibody library technology.
MorphoSys is eligible to receive royalties on net sales of Tremfya(R).
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said:
"After recent approvals of Tremfya(R) in Japan, Australia and Brazil as well
as the approvals in the U.S., Canada and the European Union seen last year,
we are very pleased about the Tremfya(R) approval in South Korea. We expect
Tremfya(R) will continue to provide an important treatment option for
patients living with moderate to severe plaque psoriasis on a truly global
basis."
In addition to psoriasis, Tremfya(R) is in phase 3 development for psoriatic
arthritis. Janssen has announced plans to investigate Tremfya(R) in Crohn's
disease.
Further information about the South Korean approval of Tremfya(R) can be
found in a press release issued by Janssen on April 15, 2018.
About Psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the
overproduction of skin cells, characterised by raised, inflamed, scaly, red
lesions, or plaques, which can cause itching and physical pain. It is
estimated that as many as 125 million people worldwide have psoriasis, and
approximately 20% of people affected have cases that are considered moderate
to severe.
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 the use of
Tremfya(R)
for the treatment of moderate to severe plaque psoriasis, expectations
regarding royalties received on Tremfya(R) sales and the further clinical
development of Tremfya(R), including for the treatment of Crohn's disease.
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 that MorphoSys' expectations regarding the use of Tremfya(R)
for the treatment of moderate to severe plaque psoriasis may be incorrect,
royalties received on Tremfya(R) sales may be less than anticipated, 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=BGSERAWFAE
Document title: Media Release
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26.04.2018 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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679735 26.04.2018
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